Extension Study of Enteric-coated Mycophenolate Sodium in Combination With Full Dose or Reduced Dose Cyclosporine Microemulsion in Patients With de Novo Kidney Transplants
January 28, 2011 updated by: Novartis
A One-year, Randomized, Open Label, Parallel Group Study to Investigate the Safety and the Effect of Enteric-coated Mycophenolate Sodium (EC-MPS) in Combination With Either Full Dose or Reduced Dose Cyclosporine Microemulsion in de Novo Kidney Transplant Recipients
This extension study is considered to allow patients being treated with EC-MPS to collect further information on the long-term safety of this drug.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
55
Phase
- Phase 3
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 to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
Inclusion/ Exclusion criteria
- All patients who completed study CERL080A2405-DE01 and who are willing to continue treatment with EC-MPS.
Other protocol-defined inclusion/exclusion criteria may apply.
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: Prevention
- 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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Efficacy based on level of serum creatinine and calculated creatinine clearance 6 months post transplantation.
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Secondary Outcome Measures
Outcome Measure |
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Efficacy based on the level of serum creatinine and calculated creatinine clearance 12 months post transplantation.
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Safety and tolerability of enteric-coated mycophenolate sodium at 6 and 12 months post transplantation
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Pharmacokinetics enteric coated mycophenolate sodium in a randomized subgroup
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Efficacy based on the incidence of biopsy-proven acute rejection, graft loss or death 6 and 12 months post transplantation.
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Efficacy based on the incidence of biopsy-proven acute rejection at 6 and 12 months post transplantation.
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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
February 1, 2003
Primary Completion (Actual)
September 1, 2005
Study Completion (Actual)
September 1, 2005
Study Registration Dates
First Submitted
October 12, 2005
First Submitted That Met QC Criteria
October 12, 2005
First Posted (Estimate)
October 14, 2005
Study Record Updates
Last Update Posted (Estimate)
January 31, 2011
Last Update Submitted That Met QC Criteria
January 28, 2011
Last Verified
January 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CERL080A2405DE01E1
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.