drugset / Trial / NCT00420472

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

NCT00420472

Phase 4 Terminated Hoffmann-La Roche
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2007-03
Primary completion
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Mycophenolate Mofetil Small molecule

Indications

No indication recorded.