Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Research Study of ATG and Rituximab in Renal Transplantation (RESTARRT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01318915
Recruitment Status : Terminated (The stopping rule for incidence of acute rejection was met.)
First Posted : March 21, 2011
Results First Posted : October 4, 2017
Last Update Posted : November 29, 2018
Sponsor:
Collaborator:
Immune Tolerance Network (ITN)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Renal Transplant Recipients
Interventions Drug: ATG
Drug: Rituximab
Drug: Tacrolimus
Drug: Sirolimus
Drug: MMF
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Induction (Rituximab and ATG)
Hide Arm/Group Description Adult living donor kidney transplant recipients were enrolled into the study prior to transplant. Participants received a novel induction regimen of ATG and rituximab that included 4 doses of ATG 1.5 mg/kg and 2 doses of rituximab 375 mg/m^2. The first dose of rituximab was given ~ day -6 pre-transplant, and the second dose on day 1-3 post-transplant. The first dose of ATG was given on the day of transplant, with the additional three doses administered on days 2-7 post-transplant (not on the same day as rituximab). Participants were maintained on anti-rejection medications tacrolimus, MMF, and sirolimus post-transplant. Participants were evaluated for eligibility to proceed with immunosuppressive maintenance withdrawal (IMW), a gradual withdrawal of their anti-rejection medications, starting as early as 26 weeks post-transplant. IMW for eligible participants proceeded with close monitoring per protocol over a period of 68-104 weeks.
Period Title: Overall Study
Started 10
Completed 9
Not Completed 1
Reason Not Completed
Lost to Follow-up             1
Arm/Group Title Induction (Rituximab and ATG)
Hide Arm/Group Description Adult living donor kidney transplant recipients were enrolled into the study prior to transplant. Participants received a novel induction regimen of ATG and rituximab that included 4 doses of ATG 1.5 mg/kg and 2 doses of rituximab 375 mg/m^2. The first dose of rituximab was given ~ day -6 pre-transplant, and the second dose on day 1-3 post-transplant. The first dose of ATG was given on the day of transplant, with the additional three doses administered on days 2-7 post-transplant (not on the same day as rituximab). Participants were maintained on anti-rejection medications tacrolimus, MMF, and sirolimus post-transplant. Participants were evaluated for eligibility to proceed with immunosuppressive maintenance withdrawal (IMW), a gradual withdrawal of their anti-rejection medications, starting as early as 26 weeks post-transplant. IMW for eligible participants proceeded with close monitoring per protocol over a period of 68-104 weeks.
Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
Participants that received induction (Rituximab and ATG) and were transplanted on study
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
<=18 years
0
   0.0%
Between 18 and 65 years
10
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants
36.6  (13.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
2
  20.0%
Male
8
  80.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
10
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
1
  10.0%
Black or African American
1
  10.0%
White
8
  80.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 10 participants
10
 100.0%
Serum Creatinine   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 10 participants
1.7  (0.73)
[1]
Measure Description: Serum creatinine provides an estimate of how well the kidneys filter (glomerular filtration rate). Higher results= poorer kidney function. The baseline creatinine interval per protocol is defined as the 2 to 4 week interval post-kidney transplant and is calculated using the lowest N=3 serum creatinine values during this pre-defined interval, the interval prior to immunosuppressive maintenance withdrawal (IMW) initiation. Normal values: Adult males, 0.7 to 1.3 mg/dL; adult females, 0.6 to 1.1 mg/dL.
eGFR   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 10 participants
55.1  (20.79)
[1]
Measure Description: Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. The equation developed by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) is used to estimate GFR (e.g., eGFR) from serum creatinine. Baseline serum creatinine was used in the equation, which is the average of the lowest three creatinine values during 2 to 4 weeks post-transplant, excluding days on dialysis.
Systolic Blood Pressure   [1] 
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 10 participants
142.3  (21.27)
[1]
Measure Description: The systolic blood pressure collected on the day of transplant. If there is no value recorded on the day of transplant, the value from the screening visit is used. Systolic blood pressure measures the pressure on the blood vessels when the heart is beats and thus is pushing blood to the rest of the body. A normal systolic blood pressure is lower than 120 mmHg. High blood pressure, also known as hypertension, is a risk factor for coronary artery disease, stroke, heart failure, and other complications if left unmanaged.
Diastolic Blood Pressure   [1] 
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 10 participants
82.5  (15.01)
[1]
Measure Description: The diastolic blood pressure collected on the day of transplant. If there is no value recorded on the day of transplant, the value from the screening visit is used. Diastolic blood pressure measures the pressure in the arteries when the heart is at rest and is thus filled with blood. A normal diastolic blood pressure is lower than 80 mmHg. High blood pressure, as known as hypertension, is a risk factor for coronary artery disease, stroke, heart failure, and other complications if left unmanaged.
Total Cholesterol   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 10 participants
181.6  (67.10)
[1]
Measure Description: The total cholesterol collected on the day of transplant. If there is no value recorded on the day of transplant, the value from the screening visit is used. Total cholesterol measures the amount of cholesterol found in the blood. Cholesterol is a waxy substance your body needs to build cells, but too much can be a problem since it can build-up in arteries. Narrowed arteries can result in heart attack or stroke. A value less than 200 mg/dL is considered good.
Glucose   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 10 participants
102.0  (22.57)
[1]
Measure Description: The glucose collected on the day of transplant. If there is no value recorded on the day of transplant, the value from the screening visit is used. Glucose, a sugar, is an energy source that the body relies on to properly function. If levels are too high for a long period of time, diabetes can develop. Diabetes can result in many long-term complications such as eye, kidney, and nerve damage, stroke, and cardiovascular complications. Fasting levels for glucose should be around 70-99 mg/dL and less than 140 mg/dL within 2 hours after a meal.
1.Primary Outcome
Title Percent of Participants Successfully Withdrawn From Immunosuppression and Remained Off Immunosuppression for at Least 52 Weeks
Hide Description Participants are considered successfully withdrawn from immunosuppression if they remained off immunosuppression for at least 52 weeks without evidence of rejection, as determined by a biopsy performed 52 weeks after completion of immunosuppression withdrawal. All participants who failed to complete immunosuppression withdrawal, regardless of reason, or failed to have a biopsy 52 weeks after completion of immunosuppression withdrawal, were considered to have failed. The endpoint is summarized with a two-sided, 95% exact binomial confidence interval.
Time Frame Transplantation through 52 weeks after discontinuation of all immunosuppression
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that received induction (Rituximab and ATG) and were transplanted on study
Arm/Group Title Induction (Rituximab and ATG)
Hide Arm/Group Description:
Adult living donor kidney transplant recipients were enrolled into the study prior to transplant. Participants received a novel induction regimen of ATG and rituximab that included 4 doses of ATG 1.5 mg/kg and 2 doses of rituximab 375 mg/m^2. The first dose of rituximab was given ~ day -6 pre-transplant, and the second dose on day 1-3 post-transplant. The first dose of ATG was given on the day of transplant, with the additional three doses administered on days 2-7 post-transplant (not on the same day as rituximab). Participants were maintained on anti-rejection medications tacrolimus, MMF, and sirolimus post-transplant. Participants were evaluated for eligibility to proceed with immunosuppressive maintenance withdrawal (IMW), a gradual withdrawal of their anti-rejection medications, starting as early as 26 weeks post-transplant. IMW for eligible participants proceeded with close monitoring per protocol over a period of 68-104 weeks.
Overall Number of Participants Analyzed 10
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percent of participants
20
(2.5 to 55.6)
2.Secondary Outcome
Title Percent of Transplanted Participants Who Remain Off Immunosuppression for at Least 52 Weeks Including Those in Whom the 52 Week Biopsy Was Not Performed
Hide Description Participants are considered successfully withdrawn from immunosuppression if they remained off immunosuppression for at least 52 weeks without evidence of rejection. A biopsy performed 52 weeks after completion of immunosuppression withdrawal confirmed that there was no sub-clinical evidence of rejection. This result considers a participant off all immunosuppression for at least 52 weeks with or without the confirmatory week 52 biopsy as a success. The endpoint is summarized with a two-sided, 95% exact binomial confidence interval.
Time Frame Transplantation through 52 weeks after discontinuation of all immunosuppression
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that received induction (Rituximab and ATG) and were transplanted on study
Arm/Group Title Induction (Rituximab and ATG)
Hide Arm/Group Description:
Adult living donor kidney transplant recipients were enrolled into the study prior to transplant. Participants received a novel induction regimen of ATG and rituximab that included 4 doses of ATG 1.5 mg/kg and 2 doses of rituximab 375 mg/m^2. The first dose of rituximab was given ~ day -6 pre-transplant, and the second dose on day 1-3 post-transplant. The first dose of ATG was given on the day of transplant, with the additional three doses administered on days 2-7 post-transplant (not on the same day as rituximab). Participants were maintained on anti-rejection medications tacrolimus, MMF, and sirolimus post-transplant. Participants were evaluated for eligibility to proceed with immunosuppressive maintenance withdrawal (IMW), a gradual withdrawal of their anti-rejection medications, starting as early as 26 weeks post-transplant. IMW for eligible participants proceeded with close monitoring per protocol over a period of 68-104 weeks.
Overall Number of Participants Analyzed 10
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percent of participants
20
(2.5 to 55.6)
3.Secondary Outcome
Title Percent of Transplanted Participants Who Remain Off Immunosuppression for the Duration of the Study as Defined as Completion of All Schedules of Events/Followed Through August 25, 2017
Hide Description Participants that remained off all immunosuppression through the completion of study participation. The endpoint is summarized with a two-sided, 95% exact binomial confidence interval.
Time Frame Transplantation through study completion (up to 4.4 years post-transplant)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that received induction (Rituximab and ATG) and were transplanted on study
Arm/Group Title Induction (Rituximab and ATG)
Hide Arm/Group Description:
Adult living donor kidney transplant recipients were enrolled into the study prior to transplant. Participants received a novel induction regimen of ATG and rituximab that included 4 doses of ATG 1.5 mg/kg and 2 doses of rituximab 375 mg/m^2. The first dose of rituximab was given ~ day -6 pre-transplant, and the second dose on day 1-3 post-transplant. The first dose of ATG was given on the day of transplant, with the additional three doses administered on days 2-7 post-transplant (not on the same day as rituximab). Participants were maintained on anti-rejection medications tacrolimus, MMF, and sirolimus post-transplant. Participants were evaluated for eligibility to proceed with immunosuppressive maintenance withdrawal (IMW), a gradual withdrawal of their anti-rejection medications, starting as early as 26 weeks post-transplant. IMW for eligible participants proceeded with close monitoring per protocol over a period of 68-104 weeks.
Overall Number of Participants Analyzed 10
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percent of participants
10
(0.3 to 44.5)
4.Secondary Outcome
Title Percent of Transplanted Participants Who Achieve Sirolimus Monotherapy Within 52 Weeks Post-transplant
Hide Description Participants that were treated with only sirolimus within 52 weeks after transplantation in those who could tolerant sirolimus. The endpoint is summarized with a two-sided, 95% exact binomial confidence interval.
Time Frame Transplantation through 52 weeks post-transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that received induction (Rituximab and ATG) and were transplanted on study that tolerated sirolimus
Arm/Group Title Induction (Rituximab and ATG)
Hide Arm/Group Description:
Adult living donor kidney transplant recipients were enrolled into the study prior to transplant. Participants received a novel induction regimen of ATG and rituximab that included 4 doses of ATG 1.5 mg/kg and 2 doses of rituximab 375 mg/m^2. The first dose of rituximab was given ~ day -6 pre-transplant, and the second dose on day 1-3 post-transplant. The first dose of ATG was given on the day of transplant, with the additional three doses administered on days 2-7 post-transplant (not on the same day as rituximab). Participants were maintained on anti-rejection medications tacrolimus, MMF, and sirolimus post-transplant. Participants were evaluated for eligibility to proceed with immunosuppressive maintenance withdrawal (IMW), a gradual withdrawal of their anti-rejection medications, starting as early as 26 weeks post-transplant. IMW for eligible participants proceeded with close monitoring per protocol over a period of 68-104 weeks.
Overall Number of Participants Analyzed 7
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percent of participants
86
(42.1 to 99.6)
5.Secondary Outcome
Title Percent of Transplanted Participants Who Achieve MMF or Mycophenolic Acid Monotherapy Within 52 Weeks Post-transplant in Those Participants Intolerant of Sirolimus
Hide Description Participants that were treated with only mycophenolate mofetil (MMF) or mycophenolic acid within 52 weeks after transplantation in those who could not tolerate sirolimus. The endpoint is summarized with a two-sided, 95% exact binomial confidence interval.
Time Frame Transplantation through 52 weeks post-transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that received induction (Rituximab and ATG) and were transplanted on study that could not tolerate sirolimus
Arm/Group Title Induction (Rituximab and ATG)
Hide Arm/Group Description:
Adult living donor kidney transplant recipients were enrolled into the study prior to transplant. Participants received a novel induction regimen of ATG and rituximab that included 4 doses of ATG 1.5 mg/kg and 2 doses of rituximab 375 mg/m^2. The first dose of rituximab was given ~ day -6 pre-transplant, and the second dose on day 1-3 post-transplant. The first dose of ATG was given on the day of transplant, with the additional three doses administered on days 2-7 post-transplant (not on the same day as rituximab). Participants were maintained on anti-rejection medications tacrolimus, MMF, and sirolimus post-transplant. Participants were evaluated for eligibility to proceed with immunosuppressive maintenance withdrawal (IMW), a gradual withdrawal of their anti-rejection medications, starting as early as 26 weeks post-transplant. IMW for eligible participants proceeded with close monitoring per protocol over a period of 68-104 weeks.
Overall Number of Participants Analyzed 3
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percent of participants
33
(0.8 to 90.6)
6.Secondary Outcome
Title Percent of Transplanted Participants Who Achieve Either Sirolimus Monotherapy or Monotherapy on a Mycophenolic Compound Within 52 Weeks Post-transplant
Hide Description Participants that were treated with only sirolimus or treated with only mycophenolate mofetil (MMF) or mycophenolic acid within 52 weeks after transplantation. The endpoint is summarized with a two-sided, 95% exact binomial confidence interval.
Time Frame Transplantation through 52 weeks post-transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that received induction (Rituximab and ATG) and were transplanted on study
Arm/Group Title Induction (Rituximab and ATG)
Hide Arm/Group Description:
Adult living donor kidney transplant recipients were enrolled into the study prior to transplant. Participants received a novel induction regimen of ATG and rituximab that included 4 doses of ATG 1.5 mg/kg and 2 doses of rituximab 375 mg/m^2. The first dose of rituximab was given ~ day -6 pre-transplant, and the second dose on day 1-3 post-transplant. The first dose of ATG was given on the day of transplant, with the additional three doses administered on days 2-7 post-transplant (not on the same day as rituximab). Participants were maintained on anti-rejection medications tacrolimus, MMF, and sirolimus post-transplant. Participants were evaluated for eligibility to proceed with immunosuppressive maintenance withdrawal (IMW), a gradual withdrawal of their anti-rejection medications, starting as early as 26 weeks post-transplant. IMW for eligible participants proceeded with close monitoring per protocol over a period of 68-104 weeks.
Overall Number of Participants Analyzed 10
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percent of participants
70
(34.8 to 93.3)
7.Secondary Outcome
Title Immunosuppression-free Duration in Days, Defined as Time From Completion of Immunosuppression Withdrawal to End of Trial Participation or to Time of Restarting Immunosuppression
Hide Description Time (in days) from when the participant is off all immunosuppression to the end of trial participation or re-initiation of immunosuppression, whichever is earliest.
Time Frame Transplantation through end of trial participation (up to 4.4 years post-transplant)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that received induction (Rituximab and ATG) and were transplanted on study that stopped using all immunosuppression drugs
Arm/Group Title Transplanted
Hide Arm/Group Description:
Adult living donor kidney transplant recipients that were enrolled into the study prior to transplant and met all criteria for study participation. These participants received a novel induction regimen of ATG and rituximab that included 4 doses of ATG 1.5 mg/kg and 2 doses of rituximab 375 mg/m^2. The first dose of rituximab was given ~day -6 prior to transplant, and the second dose was given on day 1-3 post-transplant. The first dose of ATG was given on the day of transplant, with the additional three doses administered on days 2-7 post-transplant (not on the same day as rituximab). Participants were maintained on the anti-rejection medications tacrolimus, MMF, and sirolimus after transplant. Participants were evaluated for eligibility to start gradual withdrawal of their anti-rejection medications starting as early as 26 weeks post-transplant. Eligible participants were gradually withdrawn from anti-rejection medication over a period of 68-104 weeks.
Overall Number of Participants Analyzed 6
Median (Inter-Quartile Range)
Unit of Measure: Days
374
(198 to 639)
8.Secondary Outcome
Title Time From Completion of Immunosuppression Withdrawal to First Episode of Acute Rejection or Presumed Acute Rejection
Hide Description Time (in days) from when the participant is off all immunosuppression to the first episode of biopsy proven or presumed acute rejection.
Time Frame Transplantation through end of trial participation (up to 4.4 years post-transplant)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that received induction (Rituximab and ATG) and were transplanted on study that stopped using all immunosuppression drugs and had acute rejection or presumed acute rejection.
Arm/Group Title Induction (Rituximab and ATG)
Hide Arm/Group Description:
Adult living donor kidney transplant recipients were enrolled into the study prior to transplant. Participants received a novel induction regimen of ATG and rituximab that included 4 doses of ATG 1.5 mg/kg and 2 doses of rituximab 375 mg/m^2. The first dose of rituximab was given ~day -6 pre-transplant, and the second dose was given on day 1-3 post-transplant. The first dose of ATG was given on the day of transplant, with the additional three doses administered on days 2-7 post-transplant (not on the same day as rituximab). Participants were maintained on anti-rejection medications tacrolimus, MMF, and sirolimus post-transplant. Participants were evaluated for eligibility to proceed with immunosuppressive maintenance withdrawal (IMW), a gradual withdrawal of their anti-rejection medications, starting as early as 26 weeks post-transplant. IMW for eligible participants proceeded with close monitoring per protocol over a period of 68-104 weeks.
Overall Number of Participants Analyzed 5
Median (Inter-Quartile Range)
Unit of Measure: Days
380
(198 to 452)
9.Secondary Outcome
Title Time From Completion of Immunosuppression Withdrawal to First Diagnosis of Chronic T Cell Mediated or Antibody-mediated Rejection
Hide Description Time (in days) from the time the participant is off all immunosuppression to the first episode of chronic T cell mediated or chronic antibody-mediated rejection. This assessment also includes progressive interstitial fibrosis/tubular atrophy (IF/TA), transplant glomerulopathy or chronic obliterative arteriopathy without an alternative, non-rejection related cause.
Time Frame Transplantation through end of trial participation (up to 4.4 years post-transplant)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that received induction (Rituximab and ATG) and were transplanted on study that stopped using all immunosuppression drugs and were diagnosed with chronic rejection.
Arm/Group Title Induction (Rituximab and ATG)
Hide Arm/Group Description:
Adult living donor kidney transplant recipients were enrolled into the study prior to transplant. Participants received a novel induction regimen of ATG and rituximab that included 4 doses of ATG 1.5 mg/kg and 2 doses of rituximab 375 mg/m^2. The first dose of rituximab was given ~day -6 pre-transplant, and the second dose was given on day 1-3 post-transplant. The first dose of ATG was given on the day of transplant, with the additional three doses administered on days 2-7 post-transplant (not on the same day as rituximab). Participants were maintained on anti-rejection medications tacrolimus, MMF, and sirolimus post-transplant. Participants were evaluated for eligibility to proceed with immunosuppressive maintenance withdrawal (IMW), a gradual withdrawal of their anti-rejection medications, starting as early as 26 weeks post-transplant. IMW for eligible participants proceeded with close monitoring per protocol over a period of 68-104 weeks.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Percent of Transplanted Participants With Graft Loss
Hide Description A participant is considered to have graft loss when the donated kidney needs to be removed, the participant is retransplanted with another donor kidney, or chronic dialysis is instituted. The endpoint is summarized with a two-sided, 95% exact binomial confidence interval.
Time Frame Transplantation through end of trial participation (up to 4.4 years post-transplant)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that received induction (Rituximab and ATG) and were transplanted on study.
Arm/Group Title Induction (Rituximab and ATG)
Hide Arm/Group Description:
Adult living donor kidney transplant recipients were enrolled into the study prior to transplant. Participants received a novel induction regimen of ATG and rituximab that included 4 doses of ATG 1.5 mg/kg and 2 doses of rituximab 375 mg/m^2. The first dose of rituximab was given ~day -6 pre-transplant, and the second dose was given on day 1-3 post-transplant. The first dose of ATG was given on the day of transplant, with the additional three doses administered on days 2-7 post-transplant (not on the same day as rituximab). Participants were maintained on anti-rejection medications tacrolimus, MMF, and sirolimus post-transplant. Participants were evaluated for eligibility to proceed with immunosuppressive maintenance withdrawal (IMW), a gradual withdrawal of their anti-rejection medications, starting as early as 26 weeks post-transplant. IMW for eligible participants proceeded with close monitoring per protocol over a period of 68-104 weeks.
Overall Number of Participants Analyzed 10
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percent of participants
0
(0 to 30.9)
11.Secondary Outcome
Title Percent of Transplant Participants Who Died
Hide Description Death after receiving a kidney transplant. The endpoint is summarized with a two-sided, 95% exact binomial confidence interval.
Time Frame Transplantation through end of trial participation (up to 4.4 years post-transplant)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that received induction (Rituximab and ATG) and were transplanted on study
Arm/Group Title Induction (Rituximab and ATG)
Hide Arm/Group Description:
Adult living donor kidney transplant recipients were enrolled into the study prior to transplant. Participants received a novel induction regimen of ATG and rituximab that included 4 doses of ATG 1.5 mg/kg and 2 doses of rituximab 375 mg/m^2. The first dose of rituximab was given ~day -6 pre-transplant, and the second dose was given on day 1-3 post-transplant. The first dose of ATG was given on the day of transplant, with the additional three doses administered on days 2-7 post-transplant (not on the same day as rituximab). Participants were maintained on anti-rejection medications tacrolimus, MMF, and sirolimus post-transplant. Participants were evaluated for eligibility to proceed with immunosuppressive maintenance withdrawal (IMW), a gradual withdrawal of their anti-rejection medications, starting as early as 26 weeks post-transplant. IMW for eligible participants proceeded with close monitoring per protocol over a period of 68-104 weeks.
Overall Number of Participants Analyzed 10
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percent of participants
0
(0 to 30.9)
12.Secondary Outcome
Title Percent of Transplanted Participants With Acute Rejection or Presumed Acute Rejection
Hide Description Participants with either biopsy proven acute rejection per Banff guidelines or participants that were treated for acute rejection in the absence of a biopsy. The endpoint is summarized with a two-sided, 95% exact binomial confidence interval.
Time Frame Transplantation through end of trial participation (up to 4.4 years post-transplant)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that received induction (Rituximab and ATG) and were transplanted on study.
Arm/Group Title Induction (Rituximab and ATG)
Hide Arm/Group Description:
Adult living donor kidney transplant recipients were enrolled into the study prior to transplant. Participants received a novel induction regimen of ATG and rituximab that included 4 doses of ATG 1.5 mg/kg and 2 doses of rituximab 375 mg/m^2. The first dose of rituximab was given ~day -6 pre-transplant, and the second dose was given on day 1-3 post-transplant. The first dose of ATG was given on the day of transplant, with the additional three doses administered on days 2-7 post-transplant (not on the same day as rituximab). Participants were maintained on anti-rejection medications tacrolimus, MMF, and sirolimus post-transplant. Participants were evaluated for eligibility to proceed with immunosuppressive maintenance withdrawal (IMW), a gradual withdrawal of their anti-rejection medications, starting as early as 26 weeks post-transplant. IMW for eligible participants proceeded with close monitoring per protocol over a period of 68-104 weeks.
Overall Number of Participants Analyzed 10
Geometric Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent of participants
90
(55.5 to 99.8)
13.Secondary Outcome
Title Histological Severity of Biopsies Demonstrating Acute Rejection as Measured by Banff 2007 Grade
Hide Description

Biopsy-confirmed 1.) acute cellular rejection and 2.) acute antibody-mediated rejection was classified according to Banff 2007 criteria of renal allograft pathology for renal allograft rejection. A Banff result of indeterminate was not classified as rejection.

Acute cellular rejection occurs when lesions at the site of the graft characteristically are infiltrated with large numbers of lymphocytes and macrophages that cause tissue damage. Acute cellular rejection is defined as a grade ≥ IA. Severity is graded as IA, IB, IIA, IIB, or III, with IA being the mildest form of cellular rejection and III being the most severe.

Acute antibody-mediated rejection-or humoral rejection-is defined as a grade ≥1. Severity is graded as I, II, or III, with I being the mildest form of antibody-mediated rejection and III being the most severe.

Time Frame Transplantation through end of trial participation (up to 4.4 years post-transplant)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that received induction (Rituximab and ATG) and were transplanted on study.
Arm/Group Title Induction (Rituximab and ATG)
Hide Arm/Group Description:
Adult living donor kidney transplant recipients were enrolled into the study prior to transplant. Participants received a novel induction regimen of ATG and rituximab that included 4 doses of ATG 1.5 mg/kg and 2 doses of rituximab 375 mg/m^2. The first dose of rituximab was given ~day -6 pre-transplant, and the second dose was given on day 1-3 post-transplant. The first dose of ATG was given on the day of transplant, with the additional three doses administered on days 2-7 post-transplant (not on the same day as rituximab). Participants were maintained on anti-rejection medications tacrolimus, MMF, and sirolimus post-transplant. Participants were evaluated for eligibility to proceed with immunosuppressive maintenance withdrawal (IMW), a gradual withdrawal of their anti-rejection medications, starting as early as 26 weeks post-transplant. IMW for eligible participants proceeded with close monitoring per protocol over a period of 68-104 weeks.
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: Biopsies
Acute Cellular Rejection (Type IA) 7
Acute Cellular Rejection (Type IB) 3
Acute Cellular Rejection (Type IIA) 0
Acute Cellular Rejection (Type IIB) 0
Acute Cellular Rejection (Type III) 0
Acute Antibody-Mediated Rejection (Type I) 0
Acute Antibody-Mediated Rejection (Type II) 0
Acute Antibody-Mediated Rejection (Type III) 0
14.Secondary Outcome
Title Percent of Participants With Chronic T Cell-mediated or Antibody-mediated Rejection
Hide Description This assessment included participants who experienced chronic T cell-mediated rejection or chronic antibody mediated rejection as well as progressive interstitial fibrosis/tubular atrophy (IF/TA), transplant glomerulopathy or chronic obliterative arteriopathy without an alternative, non-rejection-related cause.
Time Frame Transplantation through end of trial participation (up to 4.4 years post-transplant)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that received induction (Rituximab and ATG) and were transplanted on study.
Arm/Group Title Induction (Rituximab and ATG)
Hide Arm/Group Description:
Adult living donor kidney transplant recipients were enrolled into the study prior to transplant. Participants received a novel induction regimen of ATG and rituximab that included 4 doses of ATG 1.5 mg/kg and 2 doses of rituximab 375 mg/m^2. The first dose of rituximab was given ~day -6 pre-transplant, and the second dose was given on day 1-3 post-transplant. The first dose of ATG was given on the day of transplant, with the additional three doses administered on days 2-7 post-transplant (not on the same day as rituximab). Participants were maintained on anti-rejection medications tacrolimus, MMF, and sirolimus post-transplant. Participants were evaluated for eligibility to proceed with immunosuppressive maintenance withdrawal (IMW), a gradual withdrawal of their anti-rejection medications, starting as early as 26 weeks post-transplant. IMW for eligible participants proceeded with close monitoring per protocol over a period of 68-104 weeks.
Overall Number of Participants Analyzed 10
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percent of participants
0
(0 to 30.9)
15.Secondary Outcome
Title Time From Transplant to the First Episode of Acute Rejection Requiring Treatment
Hide Description Time (in days) from transplant to the start date of the first dose of treatment for acute rejection. This includes acute rejection episodes requiring treatment that are not biopsy proven.
Time Frame Transplantation through end of trial participation (up to 4.4 years post-transplant)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that received induction (Rituximab and ATG) and were transplanted on study that had acute rejection requiring treatment.
Arm/Group Title Induction (Rituximab and ATG)
Hide Arm/Group Description:
Adult living donor kidney transplant recipients were enrolled into the study prior to transplant. Participants received a novel induction regimen of ATG and rituximab that included 4 doses of ATG 1.5 mg/kg and 2 doses of rituximab 375 mg/m^2. The first dose of rituximab was given ~day -6 pre-transplant, and the second dose was given on day 1-3 post-transplant. The first dose of ATG was given on the day of transplant, with the additional three doses administered on days 2-7 post-transplant (not on the same day as rituximab). Participants were maintained on anti-rejection medications tacrolimus, MMF, and sirolimus post-transplant. Participants were evaluated for eligibility to proceed with immunosuppressive maintenance withdrawal (IMW), a gradual withdrawal of their anti-rejection medications, starting as early as 26 weeks post-transplant. IMW for eligible participants proceeded with close monitoring per protocol over a period of 68-104 weeks.
Overall Number of Participants Analyzed 6
Median (Inter-Quartile Range)
Unit of Measure: Days
1008.5
(577 to 1139)
16.Secondary Outcome
Title Percent of Participants Requiring Anti-lymphocyte Therapy (OKT3, ATG) for an Acute Rejection Event
Hide Description Anti-lymphocyte therapy is a drug that targets specific cells in the immune system called lymphocytes (white blood cells). This therapy helps stop the participant’s immune system from attacking the donor kidney. The endpoint is summarized with a two-sided, 95% exact binomial confidence interval.
Time Frame Transplantation through end of trial participation (up to 4.4 years post-transplant)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that received induction (Rituximab and ATG) and were transplanted on study.
Arm/Group Title Induction (Rituximab and ATG)
Hide Arm/Group Description:
Adult living donor kidney transplant recipients were enrolled into the study prior to transplant. Participants received a novel induction regimen of ATG and rituximab that included 4 doses of ATG 1.5 mg/kg and 2 doses of rituximab 375 mg/m^2. The first dose of rituximab was given ~day -6 pre-transplant, and the second dose was given on day 1-3 post-transplant. The first dose of ATG was given on the day of transplant, with the additional three doses administered on days 2-7 post-transplant (not on the same day as rituximab). Participants were maintained on anti-rejection medications tacrolimus, MMF, and sirolimus post-transplant. Participants were evaluated for eligibility to proceed with immunosuppressive maintenance withdrawal (IMW), a gradual withdrawal of their anti-rejection medications, starting as early as 26 weeks post-transplant. IMW for eligible participants proceeded with close monitoring per protocol over a period of 68-104 weeks.
Overall Number of Participants Analyzed 10
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percent of participants
20
(2.5 to 55.6)
17.Secondary Outcome
Title Number of Adverse Events, Including Number of Post-transplant Infections, Wound Complications, Lymphocoele, Post-transplant Diabetes Mellitus, and Malignancies
Hide Description Adverse events that are reported as being a post-transplant infection, wound complication, lymphocoele (a collection of fluid in the lymphatic system), post-transplant diabetes mellitus or malignancy.
Time Frame Transplantation through end of trial participation (up to 4.4 years post-transplant)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that received induction (Rituximab and ATG) and were transplanted on study
Arm/Group Title Induction (Rituximab and ATG)
Hide Arm/Group Description:
Adult living donor kidney transplant recipients were enrolled into the study prior to transplant. Participants received a novel induction regimen of ATG and rituximab that included 4 doses of ATG 1.5 mg/kg and 2 doses of rituximab 375 mg/m^2. The first dose of rituximab was given ~day -6 pre-transplant, and the second dose was given on day 1-3 post-transplant. The first dose of ATG was given on the day of transplant, with the additional three doses administered on days 2-7 post-transplant (not on the same day as rituximab). Participants were maintained on anti-rejection medications tacrolimus, MMF, and sirolimus post-transplant. Participants were evaluated for eligibility to proceed with immunosuppressive maintenance withdrawal (IMW), a gradual withdrawal of their anti-rejection medications, starting as early as 26 weeks post-transplant. IMW for eligible participants proceeded with close monitoring per protocol over a period of 68-104 weeks.
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: Events
Post-Transplant Infection 4
Wound Complications 1
Lymphocoele 0
Post-Transplant Diabetes Mellitus 0
Malignancy 0
18.Secondary Outcome
Title Participant Renal Function as Measured by GFR Using CKD-EPI
Hide Description Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. A value less than 15 indicates kidney failure, 15 to 29 indicates severe loss of kidney function, 30 to 44 indicates moderate to severe loss of kidney function, 45 to 59 mild to moderate loss of kidney function, 60 to 89 indicates mild loss of kidney function, and 90 or higher indicates normal kidney function. The equation developed by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) is used to estimate GFR from serum creatinine. The value closest to and within 6 weeks of the day expected was selected.
Time Frame 26, 52, 104, 156, and 208 Weeks Post-Transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that received induction (Rituximab and ATG) and were transplanted on study, with data available at each time point.
Arm/Group Title Induction (Rituximab and ATG)
Hide Arm/Group Description:
Adult living donor kidney transplant recipients were enrolled into the study prior to transplant. Participants received a novel induction regimen of ATG and rituximab that included 4 doses of ATG 1.5 mg/kg and 2 doses of rituximab 375 mg/m^2. The first dose of rituximab was given ~day -6 pre-transplant, and the second dose was given on day 1-3 post-transplant. The first dose of ATG was given on the day of transplant, with the additional three doses administered on days 2-7 post-transplant (not on the same day as rituximab). Participants were maintained on anti-rejection medications tacrolimus, MMF, and sirolimus post-transplant. Participants were evaluated for eligibility to proceed with immunosuppressive maintenance withdrawal (IMW), a gradual withdrawal of their anti-rejection medications, starting as early as 26 weeks post-transplant. IMW for eligible participants proceeded with close monitoring per protocol over a period of 68-104 weeks.
Overall Number of Participants Analyzed 10
Median (Inter-Quartile Range)
Unit of Measure: mL/min/1.73m^2
26 Weeks Post-Transplant Number Analyzed 10 participants
60.3
(57.1 to 64.3)
52 Weeks Post-Transplant Number Analyzed 10 participants
70.9
(57.0 to 74.6)
104 Weeks Post-Transplant Number Analyzed 7 participants
63.7
(58.6 to 69.5)
156 Weeks Post-Transplant Number Analyzed 4 participants
56.7
(54.9 to 85.6)
208 Weeks Post-Transplant Number Analyzed 4 participants
56.0
(37.5 to 94.1)
19.Secondary Outcome
Title Participant Systolic Blood Pressure Over Time
Hide Description Systolic blood pressure measures the pressure on the blood vessels when the heart is beats and thus is pushing blood to the rest of the body. A normal systolic blood pressure is lower than 120 mmHg. High blood pressure, as known as hypertension, is a risk factor for coronary artery disease, stroke, heart failure, and other complications if left unmanaged. The value closest to and within 6 weeks of the day expected was selected.
Time Frame 26, 52, 104, 156, and 208 Weeks Post-Transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that received induction (Rituximab and ATG) and were transplanted on study, with data available at each time point.
Arm/Group Title Induction (Rituximab and ATG)
Hide Arm/Group Description:
Adult living donor kidney transplant recipients were enrolled into the study prior to transplant. Participants received a novel induction regimen of ATG and rituximab that included 4 doses of ATG 1.5 mg/kg and 2 doses of rituximab 375 mg/m^2. The first dose of rituximab was given ~day -6 pre-transplant, and the second dose was given on day 1-3 post-transplant. The first dose of ATG was given on the day of transplant, with the additional three doses administered on days 2-7 post-transplant (not on the same day as rituximab). Participants were maintained on anti-rejection medications tacrolimus, MMF, and sirolimus post-transplant. Participants were evaluated for eligibility to proceed with immunosuppressive maintenance withdrawal (IMW), a gradual withdrawal of their anti-rejection medications, starting as early as 26 weeks post-transplant. IMW for eligible participants proceeded with close monitoring per protocol over a period of 68-104 weeks.
Overall Number of Participants Analyzed 10
Median (Inter-Quartile Range)
Unit of Measure: mmHg
26 Weeks Post-Transplant Number Analyzed 10 participants
131.5
(123 to 140)
52 Weeks Post-Transplant Number Analyzed 9 participants
135
(130 to 140)
104 Weeks Post-Transplant Number Analyzed 6 participants
137
(135 to 148)
156 Weeks Post-Transplant Number Analyzed 3 participants
140
(120 to 140)
208 Weeks Post-Transplant Number Analyzed 4 participants
132
(123.5 to 135)
20.Secondary Outcome
Title Participant Diastolic Blood Pressure Over Time
Hide Description Diastolic blood pressure measures the pressure in the arteries when the heart is at rest and is thus filled with blood. A normal diastolic blood pressure is lower than 80 mmHg. High blood pressure, as known as hypertension, is a risk factor for coronary artery disease, stroke, heart failure, and other complications if left unmanaged. The value closest to and within 6 weeks of the day expected was selected.
Time Frame 26, 52, 104, 156, and 208 Weeks Post-Transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that received induction (Rituximab and ATG) and were transplanted on study, with data available at each time point.
Arm/Group Title Induction (Rituximab and ATG)
Hide Arm/Group Description:
Adult living donor kidney transplant recipients were enrolled into the study prior to transplant. Participants received a novel induction regimen of ATG and rituximab that included 4 doses of ATG 1.5 mg/kg and 2 doses of rituximab 375 mg/m^2. The first dose of rituximab was given ~day -6 pre-transplant, and the second dose was given on day 1-3 post-transplant. The first dose of ATG was given on the day of transplant, with the additional three doses administered on days 2-7 post-transplant (not on the same day as rituximab). Participants were maintained on anti-rejection medications tacrolimus, MMF, and sirolimus post-transplant. Participants were evaluated for eligibility to proceed with immunosuppressive maintenance withdrawal (IMW), a gradual withdrawal of their anti-rejection medications, starting as early as 26 weeks post-transplant. IMW for eligible participants proceeded with close monitoring per protocol over a period of 68-104 weeks.
Overall Number of Participants Analyzed 10
Median (Inter-Quartile Range)
Unit of Measure: mmHg
26 Weeks Post-Transplant Number Analyzed 10 participants
77.5
(71 to 86)
52 Weeks Post-Transplant Number Analyzed 9 participants
77
(74 to 88)
104 Weeks Post-Transplant Number Analyzed 6 participants
79
(72 to 88)
156 Weeks Post-Transplant Number Analyzed 3 participants
76
(58 to 92)
208 Weeks Post-Transplant Number Analyzed 4 participants
73
(66.5 to 79.5)
21.Secondary Outcome
Title Participant Total Cholesterol Over Time
Hide Description Total cholesterol measures the amount of cholesterol found in the blood. Cholesterol is a waxy substance your body needs to build cells, but too much can be a problem since it can build-up in arteries. Narrowed arteries can result in heart attack or stroke. A value less than 200 mg/dL is considered good. The value closest to and within 12 weeks of the day expected was selected.
Time Frame 26, 52, 104, 156, and 208 Weeks Post-Transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that received induction (Rituximab and ATG) and were transplanted on study, with data available at each time point.
Arm/Group Title Induction (Rituximab and ATG)
Hide Arm/Group Description:
Adult living donor kidney transplant recipients were enrolled into the study prior to transplant. Participants received a novel induction regimen of ATG and rituximab that included 4 doses of ATG 1.5 mg/kg and 2 doses of rituximab 375 mg/m^2. The first dose of rituximab was given ~day -6 pre-transplant, and the second dose was given on day 1-3 post-transplant. The first dose of ATG was given on the day of transplant, with the additional three doses administered on days 2-7 post-transplant (not on the same day as rituximab). Participants were maintained on anti-rejection medications tacrolimus, MMF, and sirolimus post-transplant. Participants were evaluated for eligibility to proceed with immunosuppressive maintenance withdrawal (IMW), a gradual withdrawal of their anti-rejection medications, starting as early as 26 weeks post-transplant. IMW for eligible participants proceeded with close monitoring per protocol over a period of 68-104 weeks.
Overall Number of Participants Analyzed 10
Median (Inter-Quartile Range)
Unit of Measure: mg/dL
26 Weeks Post-Transplant Number Analyzed 8 participants
188
(168 to 215.5)
52 Weeks Post-Transplant Number Analyzed 4 participants
141.5
(129.5 to 170)
104 Weeks Post-Transplant Number Analyzed 8 participants
165
(149 to 172)
156 Weeks Post-Transplant Number Analyzed 3 participants
175
(153 to 199)
208 Weeks Post-Transplant Number Analyzed 3 participants
173
(118 to 285)
22.Secondary Outcome
Title Participant Glucose Level Over Time
Hide Description This is a measure of glucose found in the blood. Glucose, a sugar, is an energy source that the body relies on to properly function. If levels are too high for a long period of time, diabetes can develop. Diabetes can result in many long-term complications such as eye, kidney, and nerve damage, stroke, and cardiovascular complications. Fasting levels for glucose should be around 70-99 mg/dL and less than 140 mg/dL within 2 hours after a meal. The value closest to and within 6 weeks of the day expected was selected.
Time Frame 26, 52, 104, 156, and 208 Weeks Post-Transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that received induction (Rituximab and ATG) and were transplanted on study, with data available at each time point.
Arm/Group Title Induction (Rituximab and ATG)
Hide Arm/Group Description:
Adult living donor kidney transplant recipients were enrolled into the study prior to transplant. Participants received a novel induction regimen of ATG and rituximab that included 4 doses of ATG 1.5 mg/kg and 2 doses of rituximab 375 mg/m^2. The first dose of rituximab was given ~day -6 pre-transplant, and the second dose was given on day 1-3 post-transplant. The first dose of ATG was given on the day of transplant, with the additional three doses administered on days 2-7 post-transplant (not on the same day as rituximab). Participants were maintained on anti-rejection medications tacrolimus, MMF, and sirolimus post-transplant. Participants were evaluated for eligibility to proceed with immunosuppressive maintenance withdrawal (IMW), a gradual withdrawal of their anti-rejection medications, starting as early as 26 weeks post-transplant. IMW for eligible participants proceeded with close monitoring per protocol over a period of 68-104 weeks.
Overall Number of Participants Analyzed 10
Median (Inter-Quartile Range)
Unit of Measure: mg/dL
26 Weeks Post-Transplant Number Analyzed 10 participants
103.5
(96 to 112)
52 Weeks Post-Transplant Number Analyzed 9 participants
108
(90 to 116)
104 Weeks Post-Transplant Number Analyzed 6 participants
96.5
(83 to 129)
156 Weeks Post-Transplant Number Analyzed 4 participants
104.5
(94 to 208)
208 Weeks Post-Transplant Number Analyzed 4 participants
83.5
(75.5 to 141)
Time Frame Transplantation through end of trial participation (up to 4.4 years post-transplant).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Transplanted
Hide Arm/Group Description These are adult living donor kidney transplant recipients that were enrolled into the study prior to transplant and met all criteria for study participation. These participants received a novel induction regimen of ATG and rituximab that included 4 doses of ATG 1.5 mg/kg and 2 doses of rituximab 375 mg/m2. The first dose of rituximab was given around day -6 prior to transplant, and the second dose was given on day 1-3 post-transplant. The first dose of ATG was given on the day of transplant, with the additional three doses administered on days 2-7 post-transplant (not on the same day as rituximab). Participants were maintained on the anti-rejection medications tacrolimus, MMF, and sirolimus after transplant. Participants were evaluated for eligibility to start gradual withdrawal of their anti-rejection medications starting as early as 26 weeks post-transplant. Eligible participants were gradually withdrawn from anti-rejection medication over a period of 68-104 weeks.
All-Cause Mortality
Transplanted
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Transplanted
Affected / at Risk (%) # Events
Total   7/10 (70.00%)    
Gastrointestinal disorders   
Abdominal hernia  1  1/10 (10.00%)  1
Immune system disorders   
Transplant rejection  1  4/10 (40.00%)  4
Infections and infestations   
Pyelonephritis  1  1/10 (10.00%)  1
Injury, poisoning and procedural complications   
Incisional hernia  1  2/10 (20.00%)  2
Seroma  1  1/10 (10.00%)  1
Toxicity to various agents  1  1/10 (10.00%)  1
Nervous system disorders   
Cerebrovascular accident  1  1/10 (10.00%)  1
Renal and urinary disorders   
Nephrolithiasis  1  1/10 (10.00%)  1
Renal injury  1  1/10 (10.00%)  1
Respiratory, thoracic and mediastinal disorders   
Respiratory failure  1  1/10 (10.00%)  1
Vascular disorders   
Deep vein thrombosis  1  1/10 (10.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Transplanted
Affected / at Risk (%) # Events
Total   10/10 (100.00%)    
Blood and lymphatic system disorders   
Leukopenia  1  2/10 (20.00%)  6
Neutropenia  1  1/10 (10.00%)  1
Cardiac disorders   
Aortic valve incompetence  1  1/10 (10.00%)  1
Endocrine disorders   
Hyperparathyroidism secondary  1  1/10 (10.00%)  1
Gastrointestinal disorders   
Mouth ulceration  1  2/10 (20.00%)  2
Stomatitis  1  1/10 (10.00%)  1
General disorders   
Oedema peripheral  1  2/10 (20.00%)  2
Immune system disorders   
Transplant rejection  1  2/10 (20.00%)  2
Infections and infestations   
BK virus infection  1  1/10 (10.00%)  1
Cytomegalovirus viraemia  1  1/10 (10.00%)  1
Viraemia  1  1/10 (10.00%)  1
Investigations   
Blood creatinine increased  1  2/10 (20.00%)  4
Eosinophil count increased  1  1/10 (10.00%)  1
Lymphocyte count decreased  1  2/10 (20.00%)  5
Transaminases increased  1  2/10 (20.00%)  2
White blood cell count decreased  1  3/10 (30.00%)  3
Metabolism and nutrition disorders   
Hyperglycaemia  1  3/10 (30.00%)  3
Hyperkalaemia  1  1/10 (10.00%)  1
Hypoalbuminaemia  1  1/10 (10.00%)  1
Hyponatraemia  1  2/10 (20.00%)  4
Hypophosphataemia  1  2/10 (20.00%)  2
Musculoskeletal and connective tissue disorders   
Arthralgia  1  1/10 (10.00%)  1
Nervous system disorders   
Paraesthesia  1  1/10 (10.00%)  1
Renal and urinary disorders   
IgA nephropathy  1  1/10 (10.00%)  1
Nephropathy  1  1/10 (10.00%)  1
Proteinuria  1  2/10 (20.00%)  2
Skin and subcutaneous tissue disorders   
Skin hyperpigmentation  1  1/10 (10.00%)  1
Vascular disorders   
Hypertension  1  2/10 (20.00%)  3
Varicose vein  1  1/10 (10.00%)  1
Venous insufficiency  1  1/10 (10.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
The stopping rule for the incidence of rejection was met in December 2015, and enrollment was stopped in January 2016. After another rejection in May 2016, all participants were removed from protocol therapy and into reduced safety follow-up.
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: Director, Clinical Research Operations Program
Organization: DAIT/NIAID
Phone: 301-594-7669
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01318915     History of Changes
Other Study ID Numbers: DAIT ITN039ST
First Submitted: March 15, 2011
First Posted: March 21, 2011
Results First Submitted: May 17, 2017
Results First Posted: October 4, 2017
Last Update Posted: November 29, 2018