Trial information
A Study of the Effect of CellCept (Mycophenolate Mofetil) on Renal Function After Withdrawal of Cyclosporine in Kidney Transplant Patients
Status: Completed
Protocol number: M55012
Sponsor: F Hoffman-La Roche Ltd
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label study of the effect of CellCept on renal function after cyclosporine withdrawal in kidney transplant patients with deteriorating renal function
Brief summary: This study will assess whether CellCept improves renal function following the withdrawal of cyclosporine in kidney transplant patients with deteriorating renal function. Following the core, treatment phase, a long-term observational follow-up phase will assess whether a treatment effect is maintained over time. The anticipated time on study treatment is >2 years, and the target sample size is <100 individuals.
Target sample size is 79.
Study phase: IV
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: Kidney Transplantation
Intervention type: Drug
Intervention name: mycophenolate mofetil[CellCept]
Primary outcome: 1. Efficacy: Change in serum creatinine after withdrawal of cyclosporine
Key secondary outcomes: 1. Safety: Adverse events, opportunistic infections, malignancies
Inclusion criteria:
- adult male or female patients 18-65 years of age;
- renal transplant >=15 months previously;
- baseline biopsy and serum creatinine levels indicating deterioration of renal function within last 12 months;
- patients receiving a cyclosporine-based immunosuppressant regime;
- for follow-up phase: patients who completed the treatment phase of the study.
Exclusion criteria:
- current CellCept therapy, with cyclosporine or Prograf;
- biopsy-proven acute rejection within 3 months 3 months prior to study entry;
- female patients who are pregnant, breast-feeding or of childbearing potential, not willing to use reliable contraception during, or for 6 weeks following, conclusion of CellCept therapy;
- patients simultaneously participating in another study, or who have participated in another study within 30 days of entry into the study;
- for follow-up phase: patients who did not complete, or who switched therapy during, the treatment phase of the study.
Gender: Males or Females
Age limits: Min: 18 Years Max: 65 Years
Accepts healthy volunteers: No
Trial registration date: 05/23/2005
Date last updated: 8/19/2008
Link to trial result
This trial was conducted at the following locations:
Austria
Belgium
Brazil
- Porto Alegre
- Rio De Janeiro
- Sao Paulo
Canada
Czech Republic
France
Germany
- Bamberg
- Göttingen
- Hannover
- Jena
Spain
United Kingdom
- Bristol
- Manchester
- Portsmouth
United States
