A Study of Mycophenolate Mofetil (CellCept) in Management of Patients With Lupus Nephritis.

Completed · Phase 3 · Has a placebo group

Conditions studied: Lupus Nephritis

In brief

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 compared to azathioprine in maintaining remission and renal function. Patients were randomized to receive either MMF (1.5 g twice daily \[bid\]) or cyclophosphamide (0.5-1.0 g/m\^2 in monthly pulses) in the induction phase. Those patients meeting criteria for response were re-randomized for entry into the maintenance phase, to receive either MMF (1 g bid) or azathioprine (2 mg/kg/day).

Key facts

Study ID

NCT00377637

Run by

Hoffmann-La Roche

People needed

370

Starts

2005-07-01

Expected to finish

2010-03-01

Last updated by the study team

2011-12-06

Who can join

Age: 12 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — La Jolla, California, United States
• Study site — Los Angeles, California, United States
• Study site — San Francisco, California, United States
• Study site — San Leandro, California, United States
• Study site — Torrance, California, United States
• Study site — Miami, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Chicago, Illinois, United States
• Study site — Baltimore, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Ann Arbor, Michigan, United States
• Study site — Columbia, Missouri, United States
• Study site — Brooklyn, New York, United States
• Study site — Lake Success, New York, United States
• Study site — New York, New York, United States
• Study site — New York, New York, United States
• Study site — New York, New York, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — Durham, North Carolina, United States
• Study site — Cleveland, Ohio, United States
• Study site — Columbus, Ohio, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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