Phase 4
Completed N=210
A Study of CellCept (Mycophenolate Mofetil) Combined With Tacrolimus and Corticosteroids in Kidney Transplant Patients.
Source: ClinicalTrials.gov NCT00758602 ↗Enrolled (actual)
210
Serious AEs
2.9%
Results posted
Aug 2014
Primary outcomePrimary: Chronic Allograft Damage Index (CADI) Score at Month 12 After Transplantation — 1.82; 2.13 score on a scale — p=0.0813
Summary
This 2 arm study will compare the efficacy and safety of CellCept, combined with low or standard dose tacrolimus plus corticosteroids, in patients with kidney transplants. Patients will be randomized into one of 2 groups to receive either 1)CellCept 2.0g/day po bid + tacrolimus 10-12ng/mL followed by a maintenance dose of 8-10ng/mL + corticosteroids or 2)CellCept 2.0g/day po bid + tacrolimus 8-10ng/mL in the first 2 months,3-7ng/mL in month 3 followed by a maintenance dose of 3-5ng/mL + corticosteroids. The anticipated time on study treatment is 1 year, and the target sample size is 100-500 individuals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Chronic Allograft Damage Index (CADI) Score at Month 12 After Transplantation |
1.82; 2.13 | 0.0813 |
| PRIMARY Glomerular Filtration Rate (GFR) at Month 12 After Transplantation |
77.08; 80.12 | 0.7949 |
| SECONDARY Percentage of Participants Experiencing Acute Rejection, Graft Loss, or Death at 6 and 12 Months Post-Transplant |
2.6; 5.2; 2.6; 5.2; 0.0; 0.0 | 0.6812 |
| SECONDARY Time to First Acute Rejection Post-Transplant - Number of Participants With an Event |
2; 4 | — |
| SECONDARY Time to First Acute Rejection Post-Transplant |
40; 18 | 1.0000 |
| SECONDARY Percentage of Participants With Treatment Failure at 12 Months Post-Transplant |
9.6; 6.6 | 0.4586 |
| SECONDARY Participant and Graft Survival |
100.0; 100.0; 100.0; 99.1 | 1.0000 |
| SECONDARY Serum Creatinine (Micromoles Per Liter [µmol/L]) |
662.93; 639.70; 154.57; 115.71; 118.47; 107.08 | — |
| SECONDARY Glomerular Filtration Rate (GFR) (mL/Min) |
14.37; 15.41; 67.95; 71.02; 71.77; 72.87 | — |
Eligibility Criteria
Inclusion Criteria
- adult patients, <=75 years of age;
- single organ recipients of renal allograft;
- negative pregnancy test for women of childbearing potential; reliable contraception must be used before starting drug therapy, until 6 weeks after the last dose of study medication.
Exclusion Criteria
- severe gastrointestinal disease which may influence the absorption of oral drug therapy;
- severe infection, HIV or active hepatitis;
- active gastric ulcers;
- malignancy other than cured skin cancer;
- severe anemia, leucopenia or thrombocytopenia.
Data sourced from ClinicalTrials.gov (NCT00758602). 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.