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.