NCT00377637

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

A Prospective, Randomized, Active Controlled, Parallel Group, Multi-center Trial to Assess the Efficacy and Safety of Mycophenolate Mofetil (MMF) in Inducing Response and Maintaining Remission in Subjects With Lupus Nephritis.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 370 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 12 Years – 75 Years
• Healthy volunteers: Not accepted

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 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).

Conditions

• Lupus Nephritis

Interventions

Type	Name	Description
DRUG	Mycophenolate mofetil (MMF)	Supplied as 500 mg tablets taken orally twice a day (BID). Dose specific for each arm. Dosing started at 500 mg BID for the first week, increasing by 500 mg in subsequent weeks until the final target dose was reached.
DRUG	Cyclophosphamide	Intravenous cyclophosphamide (IVC) was administered every four weeks (monthly) to a total of six infusions. Dosing was started at 0.75 g/m\^2 of body surface area for the first month, with subsequent doses at 0.5-1.0 g/m\^2. The target dose was 1.0 g/m\^2, but doses were titrated by 0.25 g/m\^2 increments to maintain nadir leukocyte count between 2500-4000/mm\^3.
DRUG	Azathioprine	2 mg/kg/day orally, provided as 50 mg capsules to be taken after meals.
DRUG	Placebo to Azathioprine	Placebo capsules matching Azathioprine taken orally once a day.
DRUG	Placebo to Mycophenolate mofetil	Placebo tablets matching Mycophenolate mofetil taken orally twice daily.
DRUG	Corticosteroid	Oral prednisolone (or equivalent) starting at a dose of 0.75-1.0 mg/kg/day (maximum 60 mg/day) tapered to 10 mg/day.

Timeline

• Start date: 2005-07-01
• Primary completion: 2007-03-01
• Completion: 2010-03-01
• First posted: 2006-09-18
• Last updated: 2011-12-06
• Results posted: 2011-12-06

Locations

108 sites across 17 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, China, Czechia, France, Germany, Greece, Hungary, Italy, Mexico, Portugal, Spain, United Kingdom