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A Study of CellCept (Mycophenolate Mofetil) Combined With Tacrolimus and Corticosteroids in Kidney Transplant Patients.

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: NCT00758602
Recruitment Status : Completed
First Posted : September 25, 2008
Results First Posted : August 4, 2014
Last Update Posted : August 4, 2014
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Kidney Transplantation
Interventions Drug: mycophenolate mofetil
Drug: tacrolimus, standard dose
Drug: tacrolimus, low dose
Drug: corticosteroids
Enrollment 210
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Mycophenolate Mofetil (MMF), Standard Dose Tacrolimus MMF, Low Dose Tacrolimus
Hide Arm/Group Description Participants received MMF capsules, 0.75-1 gram (g) orally (PO), twice daily (BID) from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 nanograms per milliliter (ng/mL) from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice. Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
Period Title: Overall Study
Started 104 106
Completed 85 84
Not Completed 19 22
Reason Not Completed
Adverse Event             11             10
Lost to Follow-up             4             3
Withdrawal by Subject             1             3
Protocol Violation             0             2
Death             0             1
Reason not specified             3             3
Arm/Group Title MMF, Standard Dose Tacrolimus MMF, Low Dose Tacrolimus Total
Hide Arm/Group Description Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice. Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice. Total of all reporting groups
Overall Number of Baseline Participants 104 106 210
Hide Baseline Analysis Population Description
Intent-to-Treat (ITT) population: all randomized patients who received at least one dose ofthe treatment-group specific medication.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 104 participants 106 participants 210 participants
37.9  (11.05) 39.6  (10.16) 38.8  (10.62)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 104 participants 106 participants 210 participants
Female
29
  27.9%
34
  32.1%
63
  30.0%
Male
75
  72.1%
72
  67.9%
147
  70.0%
1.Primary Outcome
Title Chronic Allograft Damage Index (CADI) Score at Month 12 After Transplantation
Hide Description CADI scoring was defined for 6 histological categories: interstitial inflammatory cell infiltration (0 equals (=) no or mild inflammation, 1=approximately (~)25 percent (%) cell infiltration, 2=26-50% cell infiltration, and 3=greater than (>)50% cell infiltration); interstitial fibrosis (0=none, 1=~25% interstitial affected, 2=26-50% interstitial affected, and 3=>50% interstitial affected); tubular atrophy (0=none, 1=~15% proximal tubular atrophy [PTA], 2=16-30% PTA, and 3=>30% PTA); mesangial matrix proliferation (MMP; 0=none, 1=25% non-glomerulosclerosis [NGS] combined with moderate MMP, 2=25-50% NGS combined with MMP, and 3=>50% NGS combined with MMP); glomerular sclerosis (0=none, 1=~15% glomerulus affected, 2=16-50% glomerulus affected, and 3=>50% glomerulus affected); endothelial proliferation (EP; 0=none, 1=EP to less than (<)25% remaining artery/small artery membrane [RA/SAM], 2=EP to 26-50% [RA/SAM], and 3=>50% [RA/SAM]). CADI score was the sum of the 6 histological findings.
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population; only participants with biopsy confirmed CADI assessment 12 months post-transplantation were included in the analysis.
Arm/Group Title MMF, Standard Dose Tacrolimus MMF, Low Dose Tacrolimus
Hide Arm/Group Description:
Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
Overall Number of Participants Analyzed 57 52
Mean (Standard Deviation)
Unit of Measure: score on a scale
1.82  (1.974) 2.13  (2.000)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MMF, Standard Dose Tacrolimus, MMF, Low Dose Tacrolimus
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0813
Comments p-value, least squares (LS) mean difference, and 95% confidence interval (CI) based on analysis of covariance (ANCOVA) model with treatment, center, and the treatment-by-center interaction as fixed effects, and the donor age as a covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value 0.6581
Confidence Interval (2-Sided) 95%
-0.08 to 1.40
Estimation Comments [Not Specified]
2.Primary Outcome
Title Glomerular Filtration Rate (GFR) at Month 12 After Transplantation
Hide Description GFR was determined using the Cockcroft-Gault formula to calculate the creatinine clearance, at Month 12 after renal transplantation. For males, creatinine clearance [milliliters per minute (mL/min)] = [(140 minus age) multiplied by (*) (body weight in kg) divided by [72 * serum creatinine mg per deciliter (mg/dL)]. For females, creatinine clearance (mL/min) = 0.85 * [(140 minus age) * (body weight in kg)] divided by [72 * serum creatinine (mg/dL)].
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population; only participants with assessable parameters for the calculation of GFR were included in the analysis.
Arm/Group Title MMF, Standard Dose Tacrolimus MMF, Low Dose Tacrolimus
Hide Arm/Group Description:
Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
Overall Number of Participants Analyzed 86 82
Mean (Standard Deviation)
Unit of Measure: mL/min
77.08  (18.250) 80.12  (18.362)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MMF, Standard Dose Tacrolimus, MMF, Low Dose Tacrolimus
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7949
Comments p-value, LS mean difference, and 95% CI based on ANCOVA model with treatment, center, and the treatment-by-center interaction as fixed effects, and the donor age as a covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -1.5977
Confidence Interval (2-Sided) 95%
-13.77 to 10.58
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants Experiencing Acute Rejection, Graft Loss, or Death at 6 and 12 Months Post-Transplant
Hide Description [Not Specified]
Time Frame Months 6 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title MMF, Standard Dose Tacrolimus MMF, Low Dose Tacrolimus
Hide Arm/Group Description:
Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
Overall Number of Participants Analyzed 104 106
Measure Type: Number
Unit of Measure: percentage of participants
Acute rejection, 6 months post-transplant 2.6 5.2
Acute rejection, 12 months post-transplant 2.6 5.2
Graft loss, 6 months post-transplant 0.0 0.0
Graft loss, 12 months post-transplant 0.0 0.0
Death, 6 months post-transplant 0.0 0.0
Death, 12 months post-transplant 0.0 0.9
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MMF, Standard Dose Tacrolimus, MMF, Low Dose Tacrolimus
Comments Acute rejection, 6 months post-transplant
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6812
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MMF, Standard Dose Tacrolimus, MMF, Low Dose Tacrolimus
Comments Acute rejection, 12 months post-transplant
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6812
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MMF, Standard Dose Tacrolimus, MMF, Low Dose Tacrolimus
Comments Death, 12 months post-transplant
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
4.Secondary Outcome
Title Time to First Acute Rejection Post-Transplant - Number of Participants With an Event
Hide Description [Not Specified]
Time Frame BL, Weeks 2, 4, 13, 26, 39, and 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title MMF, Standard Dose Tacrolimus MMF, Low Dose Tacrolimus
Hide Arm/Group Description:
Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
Overall Number of Participants Analyzed 104 106
Measure Type: Number
Unit of Measure: participants
2 4
5.Secondary Outcome
Title Time to First Acute Rejection Post-Transplant
Hide Description The median time, in days, between randomization and acute rejection.
Time Frame BL, Weeks 2, 4, 13, 26, 39, and 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title MMF, Standard Dose Tacrolimus MMF, Low Dose Tacrolimus
Hide Arm/Group Description:
Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
Overall Number of Participants Analyzed 104 106
Median (95% Confidence Interval)
Unit of Measure: days
40
(13 to 67)
18
(5 to 95)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MMF, Standard Dose Tacrolimus, MMF, Low Dose Tacrolimus
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Participants With Treatment Failure at 12 Months Post-Transplant
Hide Description Treatment failure was defined by the occurrence of any of the following: use of additional maintenance immunosuppressive medication not specified in the assigned treatment group; discontinuation of any of the assigned immunosuppressants for more than 14 consecutive days or 30 cumulative days; graft loss or return to chronic dialysis; or death.
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title MMF, Standard Dose Tacrolimus MMF, Low Dose Tacrolimus
Hide Arm/Group Description:
Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
Overall Number of Participants Analyzed 104 106
Measure Type: Number
Unit of Measure: percentage of participants
9.6 6.6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MMF, Standard Dose Tacrolimus, MMF, Low Dose Tacrolimus
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4586
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
7.Secondary Outcome
Title Participant and Graft Survival
Hide Description The percentage of participants surviving with grafts intact at 6 and 12 months after renal transplant.
Time Frame Months 6 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title MMF, Standard Dose Tacrolimus MMF, Low Dose Tacrolimus
Hide Arm/Group Description:
Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
Overall Number of Participants Analyzed 104 106
Measure Type: Number
Unit of Measure: percentage of participants
6 months post-transplant 100.0 100.0
12 months post-transplant 100.0 99.1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MMF, Standard Dose Tacrolimus, MMF, Low Dose Tacrolimus
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
8.Secondary Outcome
Title Serum Creatinine (Micromoles Per Liter [µmol/L])
Hide Description The mean serum creatinine values in µmol/L at Baseline (BL), Weeks 2, 4, 13, 26, 39, and 52.
Time Frame BL, Weeks 2, 4, 13, 26, 39, and 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population; n (number) = number of participants assessed for the specified parameter at a given visit.
Arm/Group Title MMF, Standard Dose Tacrolimus MMFl, Low Dose Tacrolimus
Hide Arm/Group Description:
Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
Overall Number of Participants Analyzed 104 106
Mean (Standard Deviation)
Unit of Measure: µmol/L
Baseline (n=95,96) 662.93  (351.913) 639.70  (287.044)
Week 2 (n=101,102) 154.57  (151.374) 115.71  (52.648)
Week 4 (n=99,98) 118.47  (76.134) 107.08  (32.668)
Week 13 (n=88,91) 97.52  (24.947) 100.10  (25.345)
Week 26 (n=84,83) 105.70  (45.403) 97.51  (21.997)
Week 39 (n=83,77) 102.22  (38.035) 95.16  (20.877)
Week 52 (n=86,82) 103.10  (48.251) 94.19  (21.964)
9.Secondary Outcome
Title Glomerular Filtration Rate (GFR) (mL/Min)
Hide Description The mean GFR values in mL/min at BL, Weeks 2, 4, 13, 26, 39, and 52.
Time Frame BL, Weeks 2, 4, 13, 26, 39, and 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population; n=number of participants assessed for the specified parameter at a given visit.
Arm/Group Title MMF, Standard Dose Tacrolimus MMF, Low Dose Tacrolimus
Hide Arm/Group Description:
Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
Overall Number of Participants Analyzed 104 106
Mean (Standard Deviation)
Unit of Measure: mL/min
Baseline (n=95,96) 14.37  (8.080) 15.41  (13.759)
Week 2 (n=101,102) 67.95  (30.140) 71.02  (22.177)
Week 4 (n=99,98) 71.77  (23.578) 72.87  (19.934)
Week 13 (n=88,91) 78.13  (18.686) 75.71  (17.906)
Week 26 (n=84,83) 75.92  (21.046) 76.77  (17.536)
Week 39 (n=83,77) 77.34  (19.046) 78.00  (16.036)
Week 52 (n=86,82) 77.08  (18.250) 80.12  (18.362)
Time Frame Adverse events (AEs) were recorded from study start to 1 month after treatment completion. Treatment related serious AEs (SAEs) were reported no matter how long after the last treatment dose was administered, even though the study had been terminated.
Adverse Event Reporting Description All randomized participants were included in the safety analysis.
 
Arm/Group Title MMF, Standard Dose Tacrolimus MMF, Low Dose Tacrolimus
Hide Arm/Group Description Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice. Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
All-Cause Mortality
MMF, Standard Dose Tacrolimus MMF, Low Dose Tacrolimus
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
MMF, Standard Dose Tacrolimus MMF, Low Dose Tacrolimus
Affected / at Risk (%) Affected / at Risk (%)
Total   1/104 (0.96%)   5/106 (4.72%) 
Cardiac disorders     
Sudden death *  0/104 (0.00%)  1/106 (0.94%) 
Infections and infestations     
Cytomegalovirus (CMV) disease *  0/104 (0.00%)  1/106 (0.94%) 
Renal and urinary disorders     
Acute rejection *  1/104 (0.96%)  1/106 (0.94%) 
Transplanted renal rupture *  0/104 (0.00%)  1/106 (0.94%) 
Urethral obstruction *  0/104 (0.00%)  1/106 (0.94%) 
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
MMF, Standard Dose Tacrolimus MMF, Low Dose Tacrolimus
Affected / at Risk (%) Affected / at Risk (%)
Total   33/104 (31.73%)   37/106 (34.91%) 
Blood and lymphatic system disorders     
White blood cell (WBC) count decreased *  9/104 (8.65%)  9/106 (8.49%) 
Platelet count decreased *  1/104 (0.96%)  0/106 (0.00%) 
Endocrine disorders     
New-onset diabetes *  3/104 (2.88%)  2/106 (1.89%) 
Gastrointestinal disorders     
Diarrhea *  4/104 (3.85%)  8/106 (7.55%) 
Pyrosis *  0/104 (0.00%)  4/106 (3.77%) 
Nausea/vomiting *  1/104 (0.96%)  1/106 (0.94%) 
General disorders     
Others - not specified *  9/104 (8.65%)  8/106 (7.55%) 
Investigations     
Alanine transaminase (ALT) increased *  10/104 (9.62%)  12/106 (11.32%) 
Aspartate transamininase (AST) increased *  4/104 (3.85%)  3/106 (2.83%) 
Hyperlipemia *  3/104 (2.88%)  4/106 (3.77%) 
Hypercholesterolemia *  1/104 (0.96%)  1/106 (0.94%) 
Renal and urinary disorders     
Serum creatinine increased *  5/104 (4.81%)  4/106 (3.77%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffman-LaRoche
Phone: 800-821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00758602    
Other Study ID Numbers: ML21740
First Submitted: September 24, 2008
First Posted: September 25, 2008
Results First Submitted: July 8, 2014
Results First Posted: August 4, 2014
Last Update Posted: August 4, 2014