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

This study has been terminated.
Information provided by:
Hoffmann-La Roche Identifier:
First received: January 10, 2007
Last updated: November 19, 2007
Last verified: November 2007
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 Intervention Phase
Kidney Transplantation Drug: mycophenolate mofetil [CellCept] Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Gastrointestinal Quality of Life index, and Gastrointestinal Symptom Rating Scale, at 3 months.

Secondary Outcome Measures:
  • Efficacy: Mean dose increase of CellCept. Pharmacokinetics: Comparison of pharmacokinetic parameters under EC-MPS and CellCept therapy. Safety: AEs; acute rejection episodes.

Study Start Date: March 2007

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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Please refer to this study by its identifier: NCT00420472

Berlin, Germany, 10117
Berlin, Germany, 13353
Dresden, Germany, 01307
Essen, Germany, 45122
Hannover, Germany, 30625
Köln, Germany, 51109
Münster, Germany, 48149
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information Identifier: NCT00420472     History of Changes
Other Study ID Numbers: ML20240
Study First Received: January 10, 2007
Last Updated: November 19, 2007

Additional relevant MeSH terms:
Mycophenolic Acid
Mycophenolate mofetil
Antibiotics, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on September 19, 2017