Status:
COMPLETED
A Study of Mycophenolate Mofetil (CellCept) in Management of Patients With Lupus Nephritis.
Lead Sponsor:
Hoffmann-La Roche
Collaborating Sponsors:
Aspreva Pharmaceuticals
Conditions:
Lupus Nephritis
Eligibility:
All Genders
12-75 years
Phase:
PHASE3
Brief Summary
This 2 arm study assessed the efficacy of Mycophenolate Mofetil (MMF; CellCept) compared to cyclophosphamide in inducing a response in patients with lupus nephritis, and the long term efficacy of MMF ...
Eligibility Criteria
Inclusion
- male or female patients, 12-75 years of age;
- diagnosis of systemic lupus erythematosus;
- kidney biopsy within 6 months of study, with histological diagnosis of lupus nephritis;
- laboratory evidence of active nephritis.
Exclusion
- continuous dialysis starting \>2 weeks before randomization into induction phase, and/or with an anticipated duration of \>8 weeks;
- previous or planned kidney transplant;
- other clinically significant active medical conditions.
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
370 Patients enrolled
Trial Details
Trial ID
NCT00377637
Start Date
July 1 2005
End Date
March 1 2010
Last Update
December 6 2011
Active Locations (108)
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1
Huntsville, Alabama, United States, 35801
2
La Jolla, California, United States, 92037
3
Los Angeles, California, United States, 90095
4
San Francisco, California, United States, 94143