A Study to Evaluate Efficacy of CellCept (Mycophenolate Mofetil) in Patients With Lupus Nephritis

Roche

Status and phase: Terminated; Phase 3

Conditions: Lupus Nephritis

Treatments: Drug: Cyclophosphamide, Induction Phase; Drug: Prednisone; Drug: Mycophenolate mofetil (MMF); Drug: Cyclophosphamide, Maintenance Phase

Study type: Interventional

Funder types: Industry

Identifiers

NCT02081183

ML18989

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients >=18 years of age;
• diagnosis of systemic lupus erythematosus and lupus nephritis (class III, IV or V).

Exclusion criteria

• patients who have received cytotoxic drugs in previous 8 weeks;
• systemic infections;
• hepatitis B or C, or HIV.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

MMF, Prednisone

Experimental group

Description:

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.

Treatment:

Drug: Prednisone

Drug: Mycophenolate mofetil (MMF)

Drug: Cyclophosphamide, Induction Phase

Maintenance Cyclophosphamide, Prednisone

Active Comparator group

Description:

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.

Treatment:

Drug: Prednisone

Drug: Cyclophosphamide, Induction Phase

Drug: Cyclophosphamide, Maintenance Phase