Overview

A Study of CellCept (Mycophenolate Mofetil) in Kidney Transplant Patients Switched From EC-MPS.

Status:
Terminated
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
This study will assess the safety, efficacy and effect on quality of life of switching kidney transplant patients from reduced dose EC-MPS treatment due to gastrointestinal problems to a higher than the equimolar dose of CellCept. Patients will be switched, initially, from EC-MPS (<1440g/day) to an equimolar dose of CellCept, and at the next visit (day 10 +/- 5) the CellCept dose will be increased by 250mg/day, and the daily dose will be split into 3-4 doses. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hoffmann-La Roche
Treatments:
Mycophenolate mofetil
Mycophenolic Acid
Criteria
Inclusion Criteria:

- adult patients, >=18 years of age;

- first or second kidney transplant;

- EC-MPS therapy for >=6 months, with a stable dose for >=2 months;

- lower than recommended dose of EC-MPS (<1440g/day) due to gastrointestinal complaints.

Exclusion Criteria:

- patients who have participated in this study before;

- patients currently participating in another clinical trial, or who participated in one
during the last 30 days.