- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00420472
A Study of CellCept (Mycophenolate Mofetil) in Kidney Transplant Patients Switched From EC-MPS.
November 19, 2007 updated by: Hoffmann-La Roche
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
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Berlin, Germany, 10117
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Berlin, Germany, 13353
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Dresden, Germany, 01307
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Essen, Germany, 45122
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Hannover, Germany, 30625
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Köln, Germany, 51109
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Münster, Germany, 48149
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Gastrointestinal Quality of Life index, and Gastrointestinal Symptom Rating Scale, at 3 months.
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Secondary Outcome Measures
Outcome Measure |
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Efficacy: Mean dose increase of CellCept. Pharmacokinetics: Comparison of pharmacokinetic parameters under EC-MPS and CellCept therapy. Safety: AEs; acute rejection episodes.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2007
Study Registration Dates
First Submitted
January 10, 2007
First Submitted That Met QC Criteria
January 10, 2007
First Posted (Estimate)
January 11, 2007
Study Record Updates
Last Update Posted (Estimate)
November 20, 2007
Last Update Submitted That Met QC Criteria
November 19, 2007
Last Verified
November 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ML20240
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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