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

Kidney Transplantation Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00420472
• Other study ID #: ML20240
• Status: Terminated
• Phase: Phase 4
• First received: January 10, 2007
• Last updated: November 19, 2007
• Start date: March 2007

Study information

• Verified date: November 2007
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: BfArM - Bundesinstitut fur Arzneimittel und Medizinprodukte
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Drug:
• mycophenolate mofetil [CellCept]

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastrointestinal Quality of Life index, and Gastrointestinal Symptom Rating Scale, at 3 months.
Secondary	Efficacy: Mean dose increase of CellCept. Pharmacokinetics: Comparison of pharmacokinetic parameters under EC-MPS and CellCept therapy. Safety: AEs; acute rejection episodes.