Trial information
A Study of CellCept (Mycophenolate Mofetil) in Kidney Transplant Patients Switched From EC-MPS.
Status: Terminated
Protocol number: ML20240
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: An open-label study to evaluate the effect on quality of life of switching kidney transplant patients from reduced dose EC-MPS to a higher than the equimolar dose of CellCept
Brief 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. Target sample size is 100.
Study phase: IV
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Kidney Transplantation
Intervention type: Drug
Intervention name: mycophenolate mofetil[CellCept]
Primary outcome: 1. Gastrointestinal Quality of Life index, and Gastrointestinal Symptom Rating Scale, at 3 months.
Key secondary outcomes: 1. Efficacy: Mean dose increase of CellCept. Pharmacokinetics: Comparison of pharmacokinetic parameters under EC-MPS and CellCept therapy. Safety: AEs; acute rejection episodes.
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.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 10/17/2006
Date last updated: 8/19/2008
Link to trial result
This trial was conducted at the following locations:
Germany
- Berlin
- Dresden
- Essen
- Hannover
- Munster
