A Study of CellCept (Mycophenolate Mofetil) in Kidney Transplant Patients Switched From EC-MPS.
This study has been terminated.
Sponsor:
Hoffmann-La Roche
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00420472
First received: January 10, 2007
Last updated: November 19, 2007
Last verified: November 2007
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Purpose
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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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:
MedlinePlus related topics:
Kidney Transplantation
Drug Information available for:
Mycophenolic acid
Mycophenolate sodium
Mycophenolate mofetil hydrochloride
Mycophenolate mofetil
U.S. FDA Resources
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 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00420472
Locations
| Germany | |
| Berlin, Germany, 13353 | |
| Berlin, Germany, 10117 | |
| Dresden, Germany, 01307 | |
| Essen, Germany, 45122 | |
| Hannover, Germany, 30625 | |
| Köln, Germany, 51109 | |
| Münster, Germany, 48149 | |
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00420472 History of Changes |
| Other Study ID Numbers: | ML20240 |
| Study First Received: | January 10, 2007 |
| Last Updated: | November 19, 2007 |
| Health Authority: | Germany: BfArM - Bundesinstitut fur Arzneimittel und Medizinprodukte |
Additional relevant MeSH terms:
|
Mycophenolate mofetil Mycophenolic Acid Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013