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

Phase 4

Terminated

• Conditions: Kidney Transplantation

• Registration Number: NCT00420472
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-01-10
• Study First Submitted QC: 2007-01-10
• Study First Posted: 2007-01-11
• Study Start: 2007-03
• Status Verified: 2007-11
• Last Update Submitted: 2007-11-19
• Last Update Posted: 2007-11-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Gastrointestinal Quality of Life index, and Gastrointestinal Symptom Rating Scale, at 3 months.

Secondary Outcome Measures

Name	Time	Method
Efficacy: Mean dose increase of CellCept. Pharmacokinetics: Comparison of pharmacokinetic parameters under EC-MPS and CellCept therapy. Safety: AEs; acute rejection episodes.