A Study of CellCept (Mycophenolate Mofetil) in Kidney Transplant Patients Switched From EC-MPS.
Information source: Hoffmann-La Roche
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Kidney Transplantation
Intervention: mycophenolate mofetil [CellCept] (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: Hoffmann-La Roche Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche, +1 973 235 5000
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.
Clinical Details
Official 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
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Gastrointestinal Quality of Life index, and Gastrointestinal Symptom Rating Scale, at 3 months.
Secondary outcome: Efficacy: Mean dose increase of CellCept. Pharmacokinetics: Comparison of pharmacokinetic parameters under EC-MPS and CellCept therapy. Safety: AEs; acute rejection episodes.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
BERLIN 13353, Germany
MÜNSTER 48149, Germany
BERLIN 10117, Germany
HANNOVER 30625, Germany
KÖLN 51109, Germany
ESSEN 45122, Germany
DRESDEN 01307, Germany
Additional Information
Starting date: March 2007
Last updated: November 19, 2007
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