Phase 4
Completed N=87
A Study of CellCept (Mycophenolate Mofetil) Combined With Calcineurin Inhibitors in Liver Transplant Patients.
Source: ClinicalTrials.gov NCT00717314 ↗Enrolled (actual)
87
Serious AEs
4.8%
Results posted
Sep 2014
Primary outcomePrimary: Percentage of Participants With Decrease in Glomerular Filtration Rate (GFR) of Greater Than 20% — 5.4; 0.0 percentage of participants — p=0.494
Summary
This 2 arm study will compare the efficacy and safety of switching to CellCept combined with different regimens of reduced calcineurin inhibitors (CNI) in patients with liver transplants. Patients currently receiving CNI treatment will be randomized into one of 2 groups to receive either 1) CellCept 2.0g/day po bid + 50% reduction of CNI from baseline or 2) CellCept 2.0g/day po bid + >=75% reduction of CNI from baseline. The anticipated time on study treatment is 1 year, and the target sample size is <100 individuals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Decrease in Glomerular Filtration Rate (GFR) of Greater Than 20% |
5.4; 0.0 | 0.494 |
| SECONDARY Percentage of Participants With Graft Loss or Death at Week 52 |
0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Percentage of Participants With Biopsy-Proven Acute Rejection (BPAR) at Week 52 |
0.0; 5.9 | — |
| SECONDARY Changes From Baseline in Creatinine Clearance (Milliliters Per Minute [mL/Min]) |
1.385; 2.250; 4.884; 5.629; 5.333; 4.560 | 0.374 |
| SECONDARY Change From Baseline in Corrected Creatinine Clearance (mL/Min) at Week 52 |
6.551; 6.442 | — |
| SECONDARY Percentage Change in Creatinine Clearance From Baseline |
10.38; 8.72; 11.45; 7.51; 12.37; 7.03 | 0.616 |
| SECONDARY Percentage of Participants Experiencing Acute Rejection, Graft Loss, Death, or a Decrease From BL in Creatinine Clearance of ≥20% at Week 52 |
8.1; 8.8 | 1.000 |
Eligibility Criteria
Inclusion Criteria
- adult patients, >=18 years of age;
- single organ recipients of liver allograft;
- CNI-based immunosuppressive regimen prior to study entry and regimen adjustment;
- >=6 months post-transplant, with renal dysfunction (serum creatinine 140-300micromol/L at entry);
- negative pregnancy test for women of childbearing potential; contraception must be taken before beginning study drug therapy and until 6 weeks after last dose of study medication.
Exclusion Criteria
- treatment with CellCept or any other product which delivers mycophenolic acid within the 3 months prior to the recent switch to CellCept relevant for enrollment;
- known contraindications to CNI, corticosteroids or CellCept.
Data sourced from ClinicalTrials.gov (NCT00717314). 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.