Phase 3
Completed N=668
Comparative Study of Modified Release (MR) Tacrolimus/Mycophenolate Mofetil (MMF) in de Novo Kidney Transplant Recipients
Source: ClinicalTrials.gov NCT00064701 ↗Enrolled (actual)
668
Serious AEs
67.1%
Results posted
Sep 2013
Primary outcomePrimary: Percentage of Participants With Efficacy Failure — 15.1; 14.0; 17.0 percentage of participants
Summary
The purpose of this study is to compare the safety and efficacy of tacrolimus/mycophenolate mofetil (MMF), cyclosporine/MMF and tacrolimus modified release/MMF in de novo kidney transplant recipients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Efficacy Failure |
15.1; 14.0; 17.0 | — |
| SECONDARY Patient Survival at One Year |
93.9; 97.2; 97.2 | — |
| SECONDARY Graft Survival at One Year |
91.5; 95.3; 95.3 | — |
| SECONDARY Percentage of Participants With Biopsy Confirmed Acute Rejection at 6 and 12 Months |
3.8; 7.9; 11.8; 7.5; 10.3; 13.7 | — |
| SECONDARY Time to First Biopsy-confirmed Acute Rejection Episode |
156.00; 11.00; 52.00 | — |
| SECONDARY Number of Participants Requiring Anti-lymphocyte Antibody Therapy for Treatment of Rejection |
6; 8; 18 | — |
| SECONDARY Severity of Acute Rejection |
8; 11; 14; 4; 3; 6 | — |
| SECONDARY Number of Participants Experiencing Multiple Rejection Episodes |
2; 4; 8 | — |
| SECONDARY Number of Participants With Clinically Treated Acute Rejection Episodes |
25; 39; 45 | — |
| SECONDARY Number of Participants With Treatment Failure |
33; 31; 61 | — |
| SECONDARY Number of Participants Who Crossed Over Due to Treatment Failure |
6; 10; 39 | — |
| SECONDARY Change From Month 1 in Serum Creatinine at Month 6 and Month 12 |
-0.09; -0.08; -0.01; -0.08; -0.14; -0.04 | — |
| SECONDARY Change From Month 1 in Creatinine Clearance at Month 6 and Month 12 |
0.83; 0.47; -1.79; 1.50; 2.62; -0.25 | — |
| SECONDARY Kaplan-Meier Estimate of Patient Survival at the End of the Study |
91.2; 93.2; 91.7 | — |
| SECONDARY Kaplan-Meier Estimate of Graft Survival at the End of the Study |
82.7; 84.7; 83.9 | — |
Eligibility Criteria
Inclusion Criteria
- Recipient of a primary or retransplanted non-human leukocyte antigen (HLA)-identical living or non-HLA-identical cadaveric kidney transplant
- Age greater or equal to 12 years
Exclusion Criteria
- Recipient or donor is known seropositive for human immunodeficiency virus (HIV)
- Has current malignancy or history of malignancy
- Has significant liver disease
- Has uncontrolled concomitant infection or any other unstable medical condition
- Is receiving everolimus or enteric coated mycophenolic acid at any time during the study
- Received kidney with a cold ischemia time of equal or more than 36 hours
- Received kidney transplant from a cadaveric donor equal or more than 60 years of age
- Received intravenous immunoglobulin (IVIG) therapy prior to randomization
Data sourced from ClinicalTrials.gov (NCT00064701). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.