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

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Terminated
CT.gov ID
NCT00420472
Collaborator
(none)
7
Locations

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: mycophenolate mofetil [CellCept]
 Phase 4

Study Design

Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Mar 1, 2007

Outcome Measures

Primary Outcome Measures

  1. Gastrointestinal Quality of Life index, and Gastrointestinal Symptom Rating Scale, at 3 months. []

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Berlin Germany 10117
2 Berlin Germany 13353
3 Dresden Germany 01307
4 Essen Germany 45122
5 Hannover Germany 30625
6 Köln Germany 51109
7 Münster Germany 48149

Sponsors and Collaborators

  • Hoffmann-La Roche

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00420472
Other Study ID Numbers:
  • ML20240
First Posted:
Jan 11, 2007
Last Update Posted:
Nov 20, 2007
Last Verified:
Nov 1, 2007
Additional relevant MeSH terms:
Mycophenolic Acid

Study Results

No Results Posted as of Nov 20, 2007