Conditions: Lupus Nephritis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 370
Healthy volunteers: no

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 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).

Detailed description:

Arms:
arm 1: Participants received oral mycophenolate mofetil (MMF) 1.5 g twice a day and concomitant corticosteroids for the 24 weeks of the Induction Phase. arm 2: Participants received monthly infusions of cyclophosphamide, 0.5 to 1.0 g per square meter of body surface area and concomitant treatment with corticosteroids for the 24 week Induction Phase. arm 3: Participants received mycophenolate mofetil (MMF) 1.0 g orally twice a day, placebo to azathioprine orally once a day and corticosteroid for the 36 weeks Maintenance Phase. arm 4: Participants received azathioprine (AZA) 2 mg/kg/day orally once a day, placebo to mycophenolate mofetil orally twice a day and corticosteroid for the 36 weeks Maintenance Phase.

Interventions: intervention 1: Mycophenolate mofetil (MMF) intervention 2: Cyclophosphamide intervention 3: Azathioprine intervention 4: Placebo to Azathioprine intervention 5: Placebo to Mycophenolate mofetil intervention 6: Corticosteroid
Intervention descriptions: intervention 1: 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. intervention 2: 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. intervention 3: 2 mg/kg/day orally, provided as 50 mg capsules to be taken after meals. intervention 4: Placebo capsules matching Azathioprine taken orally once a day. intervention 5: Placebo tablets matching Mycophenolate mofetil taken orally twice daily. intervention 6: 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.

Protocol document: