Conditions: Lupus Nephritis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 16
Healthy volunteers: no

Brief summary:
This study will compare the efficacy of CellCept \[0.5-2 grams per day (g/day) orally (p.o.)\] and cyclophosphamide \[0.5-1 grams per square meter (g/m2) quarterly\] as maintenance treatment for patients with lupus nephritis. All patients will receive induction treatment with cyclophosphamide (0.5-1g/m2 monthly) for 6 months, and will then be randomized to the maintenance phase of the study for a further 6 months, followed by 6 months of treatment-free follow-up. The anticipated time on study treatment is 12 months.

Detailed description:

Arms:
arm 1: Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 to (-) 1 grams per square meter (g/m\^2), intravenously (IV) pulse once per month. Participants also received prednisone, 1 milligram per kilogram per day (mg/kg/day), orally (PO); the dose was reduced by 5 mg/day to a final dose of 10 mg/day.

Maintenance Phase (Months 7 through 12): Participants received mycophenolate mofetil (MMF), 1 g/day, PO, twice daily (BID) for 2 weeks; 1.5 g/day, PO, three times daily (TID) for the next 2 weeks; 2 g/day, PO, BID for the remainder of the Maintenance Phase. Participants also received prednisone, as in the Induction Phase. arm 2: Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 - 1 g/m\^2, IV, pulse once per month. Participants also received prednisone, 1 mg/kg/day), PO; the dose was reduced by 5 mg/day to a final dose of 10 mg/day.

Maintenance Phase (Months 7 through 12): Participants received cyclophosphamide, 0.5-1 g/m\^2, IV, pulse once every 3 months. Participants also received prednisone, as in the Induction Phase.

Interventions: intervention 1: Mycophenolate mofetil (MMF) intervention 2: Cyclophosphamide, Maintenance Phase intervention 3: Cyclophosphamide, Induction Phase intervention 4: Prednisone
Intervention descriptions: intervention 1: 1 g/day, PO BID for 2 weeks; 1.5 g/day PO TID for the next 2 weeks; and 2 g/day PO BID for the remainder of the Maintenance Phase. intervention 2: 0.5-1 g/m\^2 IV pulse once every 3 months intervention 3: 0.5 - 1 g/m\^2 IV pulse once per month intervention 4: 1 mg/kg PO once per day; reduced by 5 mg every 2 weeks up to 20 mg/day; followed by a reduction of 2.5 mg every 2 weeks until reaching the maintenance phase of 10 mg/day.

Protocol document: