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

Roche

Status and phase

Terminated

Phase 4

Conditions

Kidney Transplantation

Treatments

Drug: mycophenolate mofetil [CellCept]

Study type

Interventional

Funder types

Industry

Identifiers

NCT00420472

ML20240

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.