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Improved Induction and Maintenance Immunosuppression in Kidney Transplantation

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ClinicalTrials.gov Identifier: NCT00556933
Recruitment Status : Completed
First Posted : November 12, 2007
Results First Posted : March 2, 2015
Last Update Posted : March 2, 2015
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
R. Brian Stevens, MD, University of Nebraska

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition End-stage Renal Disease
Interventions Drug: rabbit anti-thymocyte globulin
Drug: mycophenolate mofetil
Drug: sirolimus
Drug: tacrolimus
Enrollment 180
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Single Dose rATG (6 mg/kg x 1) and Tacrolimus/Sirolimus Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus Single-dose rATG (6mg/kg ) and Sirolimus/Mycophenolate Mofetil Divided-dose rATG (1.5mg/kgx4),Sirolimus/Mycophenolate Mofetil
Hide Arm/Group Description Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) (6 mg/kg) and maintained on tacrolimus and sirolimus for chronic immunosuppression. Kidney transplant recipients given 4 small doses (1.5 mg/kg) of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression. Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG, 6 mg/kg x 1) and maintained on tacrolimus and sirolimus for chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months. Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG, 1.5 mg/kg x 4) and maintained on tacrolimus and sirolimus for chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.
Period Title: Single vs. Divided-dose rATG Induction
Started 45 45 45 45
Completed 43 37 39 43
Not Completed 2 8 6 2
Reason Not Completed
Protocol Violation             2             3             3             0
Withdrawal by Subject             0             0             1             0
Pancreas transplantation             0             2             2             2
Death             0             1             0             0
Lost to Follow-up             0             1             0             0
Kidney graft primary non-function             0             1             0             0
Period Title: CNI Withdrawal vs. Minimization
Started 43 37 39 43
Completed 42 33 36 41
Not Completed 1 4 3 2
Reason Not Completed
Pancreas transplantation             1             1             0             0
Lost to Follow-up             0             1             0             1
Withdrawal by Subject             0             1             1             0
Graft loss             0             1             2             0
Death             0             0             0             1
Arm/Group Title Single Dose rATG (6 mg/kg x 1) and Tacrolimus/Sirolimus Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus Single-dose rATG (6mg/kg ) and Sirolimus/Mycophenolate Mofetil Divided-dose rATG (6mg/kg ) and Sirolimus/Mycophenolate Mofeti Total
Hide Arm/Group Description

Kidney transplant patients receive 6 mg/kg of rATG as a single dose administered intravenously over <24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation. Chronic maintenance immunosuppression is with tacrolimus and sirolimus.

Sirolimus, oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection

Tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection.

Kidney transplant patients receive 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6. Chronic maintenance immunosuppression is with tacrolimus and sirolimus.

Sirolimus, oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection

Tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection.

Kidney transplant receive the same treatment as in Group 1, until tacrolimus is replaced with mycophenolate mofetil after about 6 months.

Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney.

Sirolimus, oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection

Tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection.

Kidney transplant receive the same treatment as in Group 2, until tacrolimus is replaced with mycophenolate mofetil after about 6 months.

Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney.

Sirolimus, oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection

Tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection..

Total of all reporting groups
Overall Number of Baseline Participants 44 44 45 45 178
Hide Baseline Analysis Population Description
Two patients were enrolled into the study erroneously in a violation of protocol and were identified and excluded before any study-related interventions. (Additional patients excluded from outcome analyses are accounted for in the Participant Flow and Outcome modules.)
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 44 participants 44 participants 45 participants 45 participants 178 participants
45.8  (12) 47.1  (11.2) 44.1  (13.2) 51.6  (9.7) 47.2  (11.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants 44 participants 45 participants 45 participants 178 participants
Female
15
  34.1%
14
  31.8%
11
  24.4%
17
  37.8%
57
  32.0%
Male
29
  65.9%
30
  68.2%
34
  75.6%
28
  62.2%
121
  68.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 44 participants 44 participants 45 participants 45 participants 178 participants
Caucasian/Asian 39 38 39 41 157
Non Caucasian/Asian 5 6 6 4 21
Patient Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 44 participants 44 participants 45 participants 45 participants 178 participants
28.5  (5.0) 27.9  (6.6) 28.8  (7.0) 28.9  (6.9) 28.5  (5.7)
Donor type  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 44 participants 44 participants 45 participants 45 participants 178 participants
Deceased donor 18 17 18 17 70
Living donor 26 27 27 28 108
Deceased-donor Cold Ischemia Time  
Mean (Standard Deviation)
Unit of measure:  Hours
Number Analyzed 44 participants 44 participants 45 participants 45 participants 178 participants
14.3  (7) 13.7  (4.1) 14.7  (5.7) 15.4  (11) 14.5  (7.2)
Patient Panel Reactive Antibody (PRA)(%)  
Mean (Standard Deviation)
Unit of measure:  % reactive
Number Analyzed 44 participants 44 participants 45 participants 45 participants 178 participants
0.6  (2.3) 1.0  (4.8) 1.1  (6.3) 1.3  (7.8) 1.0  (5.6)
Donor/recipient height ratio  
Mean (Standard Deviation)
Unit of measure:  Ratio
Number Analyzed 44 participants 44 participants 45 participants 45 participants 178 participants
0.98  (0.07) 1.00  (0.17) 0.98  (0.16) 1.00  (0.16) 0.99  (0.1)
Donor age  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 44 participants 44 participants 45 participants 45 participants 178 participants
40.4  (13.1) 44.7  (10.0) 37.4  (12.1) 41.2  (14.0) 40.9  (12.7)
Donor gender  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 44 participants 44 participants 45 participants 45 participants 178 participants
Male 18 23 17 20 78
Female 26 21 28 25 100
Donor BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 44 participants 44 participants 45 participants 45 participants 178 participants
27.7  (5.7) 27.3  (4.0) 27.1  (4.2) 28.3  (5.1) 27.6  (4.8)
Donor final serum creatinine  
Mean (Standard Deviation)
Unit of measure:  Mg/dl
Number Analyzed 44 participants 44 participants 45 participants 45 participants 178 participants
1.0  (0.3) 1.1  (0.6) 1.0  (0.5) 1.0  (0.5) 1.0  (0.5)
Adult Cadaver Donor Nyberg Grade   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 44 participants 44 participants 45 participants 45 participants 178 participants
10.5  (7.5) 14.6  (7.0) 11.8  (6.9) 15.4  (7.8) 13.1  (7.4)
[1]
Measure Description: Nyberg et al (AmJourTrans 2001; 1: 162–170) developed a deceased-donor kidney grading system to predict early graft dysfunction and failure; developed from seven donor variables (cause of death, 0–6 points; history of hypertension, 0–6; final creatinine clearance before procurement, 0–6; age, 0–6; history of diabetes mellitus, 0–3; cold ischemia time, 0–3; and severity of renal artery plaque, 0–3). It stratifies deceased-donor kidneys by score: grade A, 0–5 points; grade B, 6– 10; grade C, 11–15; and grade D, 16–32. Risk of delayed graft function was 17% in Group A and 62% in group D.
Pediatric vs. Adult Donor  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 44 participants 44 participants 45 participants 45 participants 178 participants
Pediatric donor 3 1 3 3 10
Adult donor 41 43 42 42 168
Donor/Recipient High-Risk CMV Serostatus   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 44 participants 44 participants 45 participants 45 participants 178 participants
CMV High-risk 23 27 25 33 108
CMV Low-risk 21 17 20 12 70
[1]
Measure Description:

Donor/Recipient High-Risk CMV Serostatus = Donor CMV Positive/Recipient CMV Positive or Negative

Donor/Recipient Low-Risk CMV Serostatus = Donor CMV Negative/Recipient CMV Positive or Negative

1.Primary Outcome
Title Chronic Allograft Nephropathy (Cumulative Calcineurin-inhibitor Nephrotoxicity/Transplant Nephropathy) Per Protocol Surveillance Kidney Biopsies (Banff Grading Criteria).
Hide Description Protocol kidney biopsies collected at approximately 12 and 24 months were scored by a transplant renal pathologist blinded to treatment group assignment for evidence of rejection, BK virus nephropathy, antibody-mediated rejection, recurrent disease, inflammation, and Banff 2005 categories of chronic renal injury. Chronic injury categories were arteriolar hyaline thickening (ah), allograft glomerulopathy (cg), interstitial fibrosis (ci), tubular atrophy (ct), and vascular fibrous intimal thickening (cv). Severity scores within each category could be 0 (<5%; none or minimal), 1 (>5% - <25%; mild), 2 (>25% - <50%, moderate), or 3 (>50%, severe). The proportions of patients in each severity grade (0, 1, 2, and 3) for both the individual categories and a composite were compared using Fisher’s exact test.
Time Frame Two years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Dose rATG (6 mg/kg x 1) and Tacrolimus/Sirolimus Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus Single-dose rATG (6mg/kg ) and Sirolimus/Mycophenolate Mofetil Divided-dose rATG(6mg/kg ) and Sirolimus/Mycophenolate Mofetil
Hide Arm/Group Description:

Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.

rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.

sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection

tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection.

Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.

rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.

sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection

tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection.

Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.

Rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.

Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels.

Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.

Rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.

Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney.

Overall Number of Participants Analyzed 36 29 28 29
Measure Type: Number
Unit of Measure: percentage of participants
Banff histopathology cumulative grade = 0 43 40 53 51
Banff histopathology cumulative grade = 1 37 46 45 41
Banff histopathology cumulative grade = 2 16 9 2 7
Banff histopathology cumulative grade = 3 4 6 0 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Single Dose rATG (6 mg/kg x 1) and Tacrolimus/Sirolimus, Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus, Single-dose rATG (6mg/kg ) and Sirolimus/Mycophenolate Mofetil, Divided-dose rATG(6mg/kg ) and Sirolimus/Mycophenolate Mofetil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
2.Primary Outcome
Title Average of Renal Function
Hide Description Calculated Glomerular Filtration Rate (GFR) by using the abbreviated MDRD (aMDRD) formula and patient serum creatinine and demographic data; averaged values from months four through 24.
Time Frame Two years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Dose rATG (6 mg/kg x 1) and Tacrolimus/Sirolimus Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus Single-dose rATG (6mg/kg ) and Sirolimus/Mycophenolate Mofetil Divided-dose rATG(6mg/kg ) and Sirolimus/Mycophenolate Mofetil
Hide Arm/Group Description:

Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.

rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.

sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection

tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection.

Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.

rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.

sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection

tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection.

Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression; tacrolimus is replaced with mycophenolate mofetil after about 6 months.

rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.

mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and i

Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression; tacrolimus is replaced with mycophenolate mofetil after about 6 months.

mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney.

rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.

sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough leve

Overall Number of Participants Analyzed 43 38 42 44
Mean (Standard Deviation)
Unit of Measure: ml/min/1.73m2
Average GFR, months 1-3 50.4  (16.0) 50.1  (12.5) 53.6  (14.4) 50.4  (17.0)
Average GFR, months 4-6 57.3  (17.6) 57.3  (12.5) 60.2  (15.6) 54.8  (13.2)
Average GFR, months 7-9 54.8  (16.5) 55.0  (11.8) 61.0  (15.8) 55.8  (13.2)
Average GFR, months 10-12 55.8  (16.6) 55.6  (12.1) 57.4  (16.7) 56.6  (14.4)
Average GFR, months 13-15 56.8  (19.2) 57.3  (14.3) 61.8  (15.4) 58.5  (16.6)
Average GFR, months 16-18 57.6  (20.9) 56.3  (14.8) 62.3  (17.6) 56.6  (18.4)
Average GFR, months 19-21 56.6  (20.0) 54.8  (17.3) 60.2  (14.7) 56.8  (18.9)
Average GFR, months 22-24 56.9  (21.9) 57.0  (16.2) 62.9  (18.6) 57.6  (17.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Single Dose rATG (6 mg/kg x 1) and Tacrolimus/Sirolimus, Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus, Single-dose rATG (6mg/kg ) and Sirolimus/Mycophenolate Mofetil, Divided-dose rATG(6mg/kg ) and Sirolimus/Mycophenolate Mofetil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.45
Comments [Not Specified]
Method General Linear Model
Comments [Not Specified]
3.Secondary Outcome
Title Safety Profile
Hide Description Number of events: cytomegalovirus (CMV) disease, opportunistic infections (bacteremia, abscess, pneumonia, fungal), Post-transplantation Lymphoproliferative Disorder (PTLD), wound healing problems within 30 days, and lymphoceles.
Time Frame Two years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Dose rATG (6 mg/kg x 1) and Tacrolimus/Sirolimus Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus Ingle-dose rATG (6mg/kg ) and Sirolimus/Mycophenolate Mofetil Divided-dose rATG(6mg/kg ) and Sirolimus/Mycophenolate Mofetil
Hide Arm/Group Description:

Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.

rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.

sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection

tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection.

Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.

rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.

sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection

tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection.

Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.

Rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.

Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels.

Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.

Rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.

Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney.

Overall Number of Participants Analyzed 43 43 43 44
Overall Number of Units Analyzed
Type of Units Analyzed: Number of possible events
215 215 215 220
Measure Type: Number
Unit of Measure: Events
11 14 10 17
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Single Dose rATG (6 mg/kg x 1) and Tacrolimus/Sirolimus, Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus, Ingle-dose rATG (6mg/kg ) and Sirolimus/Mycophenolate Mofetil, Divided-dose rATG(6mg/kg ) and Sirolimus/Mycophenolate Mofetil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.53
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
4.Secondary Outcome
Title Requirement for Additional Immunosuppression (Such as Corticosteroids, Antimetabolites or Other Immunosuppressive Agents)
Hide Description [Not Specified]
Time Frame Two years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Dose rATG (6 mg/kg x 1) and Tacrolimus/Sirolimus Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus Single-dose rATG (6mg/kg ) and Sirolimus/Mycophenolate Mofetil Divided-dose rATG(6mg/kg ) and Sirolimus/Mycophenolate Mofetil
Hide Arm/Group Description:

Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.

rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.

sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection

tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection.

Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.

rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.

sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection

tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection.

Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.

Rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.

Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels.

Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.

Rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.

Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney.

Overall Number of Participants Analyzed 43 42 41 45
Measure Type: Number
Unit of Measure: participants
7 5 6 11
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Single Dose rATG (6 mg/kg x 1) and Tacrolimus/Sirolimus, Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus, Single-dose rATG (6mg/kg ) and Sirolimus/Mycophenolate Mofetil, Divided-dose rATG(6mg/kg ) and Sirolimus/Mycophenolate Mofetil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.463
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
5.Secondary Outcome
Title Acute Rejection Per Kidney Biopsy (Banff Grading Criteria)
Hide Description [Not Specified]
Time Frame Two years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Dose rATG (6 mg/kg x 1) and Tacrolimus/Sirolimus Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus Single-dose rATG (6mg/kg ) and Sirolimus/Mycophenolate Mofetil Divided-dose rATG(1.5mg/kgx4), Sirolimus/Mycophenolate Mofetil
Hide Arm/Group Description:

Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.

rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.

sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection

tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection.

Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.

rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.

sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection

tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection.

Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.

Rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.

Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels.

Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.

Rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.

Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney.

Overall Number of Participants Analyzed 43 42 41 45
Measure Type: Number
Unit of Measure: participants
7 4 8 9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Single Dose rATG (6 mg/kg x 1) and Tacrolimus/Sirolimus, Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus, Single-dose rATG (6mg/kg ) and Sirolimus/Mycophenolate Mofetil, Divided-dose rATG(1.5mg/kgx4), Sirolimus/Mycophenolate Mofetil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.67
Comments [Not Specified]
Method Kaplan-Meier
Comments [Not Specified]
6.Secondary Outcome
Title Acute Tubular Necrosis (ATN) Rate, Defined as the Requirement for Dialysis Within 7 Days Post-transplantation.
Hide Description [Not Specified]
Time Frame Seven days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Dose rATG (6 mg/kg x 1) and Tacrolimus/Sirolimus Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus Single-dose rATG (6mg/kg ) and Sirolimus/Mycophenolate Mofetil Divided-dose rATG(1.5mg/kgx4); Sirolimus/Mycophenolate Mofetil
Hide Arm/Group Description:

Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.

rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.

sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection

tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection.

Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.

rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.

sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection

tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection.

Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.

Rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.

Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels.

Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.

Rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.

Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney.

Overall Number of Participants Analyzed 41 43 43 44
Measure Type: Number
Unit of Measure: participants
3 1 6 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Single Dose rATG (6 mg/kg x 1) and Tacrolimus/Sirolimus, Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus, Single-dose rATG (6mg/kg ) and Sirolimus/Mycophenolate Mofetil, Divided-dose rATG(1.5mg/kgx4); Sirolimus/Mycophenolate Mofetil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.193
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
7.Secondary Outcome
Title Graft Survival
Hide Description Graft failure = permanent return of patient to dialysis.
Time Frame Two years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Dose rATG (6 mg/kg) and Tacrolimus/Sirolimus Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus Single-dose rATG (6mg/kg) and Sirolimus/Mycophenolate Mofetil Divided-dose rATG(1.5mg/kgx4); Sirolimus/Mycophenolate Mofetil
Hide Arm/Group Description:

Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.

rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.

sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection

tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection.

Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.

rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.

sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection

tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection.

Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.

Rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.

Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels.

Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.

Rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.

Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney.

Overall Number of Participants Analyzed 41 43 43 44
Measure Type: Number
Unit of Measure: participants
0 1 2 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Single Dose rATG (6 mg/kg) and Tacrolimus/Sirolimus, Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus, Single-dose rATG (6mg/kg) and Sirolimus/Mycophenolate Mofetil, Divided-dose rATG(1.5mg/kgx4); Sirolimus/Mycophenolate Mofetil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.422
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
8.Secondary Outcome
Title Patient Survival
Hide Description [Not Specified]
Time Frame Two years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Dose rATG (6 mg/kg) and Tacrolimus/Sirolimus Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus Single-dose rATG (6mg/kg) and Sirolimus/Mycophenolate Mofetil Divided-dose rATG(1.5mg/kgx4); Sirolimus/Mycophenolate Mofetil
Hide Arm/Group Description:

Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.

rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.

sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection

tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection.

Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.

rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.

sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection

tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection.

Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.

Rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.

Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels.

Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.

Rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.

Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney.

Overall Number of Participants Analyzed 44 44 45 45
Measure Type: Number
Unit of Measure: participants
0 1 0 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Single Dose rATG (6 mg/kg) and Tacrolimus/Sirolimus, Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus, Single-dose rATG (6mg/kg) and Sirolimus/Mycophenolate Mofetil, Divided-dose rATG(1.5mg/kgx4); Sirolimus/Mycophenolate Mofetil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.871
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
9.Secondary Outcome
Title Lymphoid Cell Sub-type CD3 Absolute Numbers
Hide Description [Not Specified]
Time Frame One year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Dose rATG (6 mg/kg) and Tacrolimus/Sirolimus Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus Single-dose rATG (6mg/kg) and Sirolimus/Mycophenolate Mofetil Divided-dose rATG(1.5mg/kgx4); Sirolimus/Mycophenolate Mofetil
Hide Arm/Group Description:

Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.

rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.

sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection

tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection.

Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.

rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.

sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection

tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection.

Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression; tacrolimus is replaced with mycophenolate mofetil after about 6 months.

rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.

mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and i

Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression; tacrolimus is replaced with mycophenolate mofetil after about 6 months.

mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney.

rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.

sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough leve

Overall Number of Participants Analyzed 25 26 24 30
Mean (Standard Deviation)
Unit of Measure: CD3 Cell Numbers/mm^3
446  (403) 375  (564) 392  (319) 266  (211)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Single Dose rATG (6 mg/kg) and Tacrolimus/Sirolimus, Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus, Single-dose rATG (6mg/kg) and Sirolimus/Mycophenolate Mofetil, Divided-dose rATG(1.5mg/kgx4); Sirolimus/Mycophenolate Mofetil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.068
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
10.Secondary Outcome
Title New-onset Polyomavirus (BK Virus) Disease Per Kidney Biopsy
Hide Description [Not Specified]
Time Frame Two years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Dose rATG (6 mg/kg) and Tacrolimus/Sirolimus Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus Single-dose rATG (6mg/kg) and Sirolimus/Mycophenolate Mofetil Divided-dose rATG(1.5mg/kgx4); Sirolimus/Mycophenolate Mofetil
Hide Arm/Group Description:

Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.

rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.

sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection

tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection.

Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.

rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.

sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection

tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection.

Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.

Rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.

Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels.

Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.

Rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.

Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney.

Overall Number of Participants Analyzed 43 43 43 44
Measure Type: Number
Unit of Measure: participants
1 2 0 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Single Dose rATG (6 mg/kg) and Tacrolimus/Sirolimus, Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus, Single-dose rATG (6mg/kg) and Sirolimus/Mycophenolate Mofetil, Divided-dose rATG(1.5mg/kgx4); Sirolimus/Mycophenolate Mofetil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.67
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
11.Secondary Outcome
Title New-onset Diabetes and Hyperglycemia After Transplantation (NODAT)
Hide Description [Not Specified]
Time Frame Six months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Dose rATG (6 mg/kg) and Tacrolimus/Sirolimus Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus Single-dose rATG (6mg/kg) and Sirolimus/Mycophenolate Mofetil Divided-dose rATG(1.5mg/kgx4); Sirolimus/Mycophenolate Mofetil
Hide Arm/Group Description:

Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.

rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.

sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection

tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection.

Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.

rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.

sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection

tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection.

Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.

Rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.

Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels.

Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.

Rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.

Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney.

Overall Number of Participants Analyzed 26 26 22 24
Measure Type: Number
Unit of Measure: participants
10 7 5 12
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Single Dose rATG (6 mg/kg) and Tacrolimus/Sirolimus, Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus, Single-dose rATG (6mg/kg) and Sirolimus/Mycophenolate Mofetil, Divided-dose rATG(1.5mg/kgx4); Sirolimus/Mycophenolate Mofetil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.21
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
12.Secondary Outcome
Title Ratio of CD4/CD8 Lymphoid Cells
Hide Description [Not Specified]
Time Frame One year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Dose rATG (6 mg/kg) and Tacrolimus/Sirolimus Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus Single-dose rATG (6mg/kg) and Sirolimus/Mycophenolate Mofetil Divided-dose rATG(1.5mg/kgx4); Sirolimus/Mycophenolate Mofetil
Hide Arm/Group Description:

Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.

rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.

sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection

tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection.

Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.

rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.

sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection

tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection.

Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.

Rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.

Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels.

Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.

Rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.

Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney.

Overall Number of Participants Analyzed 25 23 23 29
Mean (Standard Deviation)
Unit of Measure: Ratio of cell counts
0.84  (0.55) 0.84  (0.41) 0.98  (0.53) 1.01  (0.57)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Single Dose rATG (6 mg/kg) and Tacrolimus/Sirolimus, Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus, Single-dose rATG (6mg/kg) and Sirolimus/Mycophenolate Mofetil, Divided-dose rATG(1.5mg/kgx4); Sirolimus/Mycophenolate Mofetil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.40
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Time Frame Up to two years.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1 Group 2 Group 3 Group 4
Hide Arm/Group Description

Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.

rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.

sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection

tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection.

Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.

rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.

sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection

tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection.

Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression; tacrolimus is replaced with mycophenolate mofetil after about 6 months.

rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.

mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and i

Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression; tacrolimus is replaced with mycophenolate mofetil after about 6 months.

mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney.

rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.

sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough leve

All-Cause Mortality
Group 1 Group 2 Group 3 Group 4
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Group 1 Group 2 Group 3 Group 4
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   9/44 (20.45%)   15/44 (34.09%)   18/45 (40.00%)   21/45 (46.67%) 
Cardiac disorders         
Myocardial Infarction  [1]  0/44 (0.00%)  1/44 (2.27%)  1/45 (2.22%)  1/45 (2.22%) 
Cardiac Arrhythmia  [2]  0/44 (0.00%)  0/44 (0.00%)  0/45 (0.00%)  2/45 (4.44%) 
General disorders         
Death   0/44 (0.00%)  1/44 (2.27%)  0/45 (0.00%)  1/45 (2.22%) 
Immune system disorders         
Serum Sickness  [3]  0/44 (0.00%)  1/44 (2.27%)  0/45 (0.00%)  2/45 (4.44%) 
Infections and infestations         
Wound Abscess  [4]  0/44 (0.00%)  0/44 (0.00%)  3/45 (6.67%)  0/45 (0.00%) 
Injury, poisoning and procedural complications         
Rabbit Anti-Thymocyte Globulin (rATG) Reaction   1/44 (2.27%)  2/44 (4.55%)  4/45 (8.89%)  2/45 (4.44%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Cancer   0/44 (0.00%)  2/44 (4.55%)  2/45 (4.44%)  1/45 (2.22%) 
Renal and urinary disorders         
Acute Tubular Necrosis   3/44 (6.82%)  1/44 (2.27%)  6/45 (13.33%)  2/45 (4.44%) 
Renal Allograft Primary Non-function  [5]  0/44 (0.00%)  1/44 (2.27%)  0/45 (0.00%)  0/45 (0.00%) 
Renal Allograft Failure  [6]  0/44 (0.00%)  1/44 (2.27%)  2/45 (4.44%)  0/45 (0.00%) 
Ureteral Stricture  [7]  2/44 (4.55%)  3/44 (6.82%)  1/45 (2.22%)  1/45 (2.22%) 
Surgical and medical procedures         
Wound Dehiscence   1/44 (2.27%)  1/44 (2.27%)  0/45 (0.00%)  0/45 (0.00%) 
Lymphocele Requiring Drainage  [8]  3/44 (6.82%)  1/44 (2.27%)  2/45 (4.44%)  4/45 (8.89%) 
Repair of Wound Hernia at Transplantation Incision   2/44 (4.55%)  4/44 (9.09%)  1/45 (2.22%)  9/45 (20.00%) 
Indicates events were collected by systematic assessment
[1]
Myocardial infarction within 30 days of transplantation.
[2]
Cardiac arrhythmia within 30 days of transplantation.
[3]
Response to rabbit anti-thymocyte globulin administration
[4]
Abscess at site of transplantation incision
[5]
No or insufficient graft function from time of transplantation.
[6]
Insufficient graft function necessitating permanent return to dialysis.
[7]
Obstruction develops in outflow tract of transplanted kidney.
[8]
Failure of spontaneous resolution of lymph accumulation at site of transplanted kidney.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Group 1 Group 2 Group 3 Group 4
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   12/44 (27.27%)   12/44 (27.27%)   11/45 (24.44%)   8/45 (17.78%) 
Blood and lymphatic system disorders         
Incomplete Rabbit Anti-Thymocyte Globulin Induction  [1]  1/44 (2.27%)  2/44 (4.55%)  4/45 (8.89%)  0/45 (0.00%) 
Metabolism and nutrition disorders         
New-onset Hyperlipidemia after Transplantation   11/44 (25.00%)  10/44 (22.73%)  7/45 (15.56%)  8/45 (17.78%) 
Indicates events were collected by systematic assessment
[1]
Administration of rabbit anti-thymocyte globulin interrupted by adverse reaction.
The trial is designed for analysis as 1st, rATG dosing, and 2nd, CNI withdrawal status. Results published as analysis of 2 induction protocols followed by analysis of 2 CNI maintenance regimens. Potential limitations = single-center & non-blinded.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: R. Brian Stevens, MD, PhD
Organization: Wright State University, Dayton, Ohio
Phone: 937-545-4817
Responsible Party: R. Brian Stevens, MD, University of Nebraska
ClinicalTrials.gov Identifier: NCT00556933     History of Changes
Other Study ID Numbers: 286-03
First Submitted: November 9, 2007
First Posted: November 12, 2007
Results First Submitted: January 29, 2015
Results First Posted: March 2, 2015
Last Update Posted: March 2, 2015