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

Roche

Status and phase: Terminated; Phase 3

Conditions: Lupus Nephritis

Treatments: Drug: Corticosteroids; Drug: Cyclophosphamide; Drug: Azathioprine; Drug: Mycophenolate Mofetil

Study type: Interventional

Funder types: Industry

Identifiers

NCT00425438

ML19978

Details and patient eligibility

About

This 2 arm study will compare the efficacy and safety of CellCept plus corticosteroids, versus cyclophosphamide plus corticosteroids in the induction phase followed by azathioprine in the maintenance phase, in maintaining remission and renal function in patients with lupus nephritis. Patients will be randomized to receive CellCept 1g bid po plus corticosteroids for 24 weeks, followed by CellCept 0.75g bid po plus corticosteroids for the following 24 weeks, or cyclophosphamide 0.5-1.0g/m2 monthly plus corticosteroids for 24 weeks, followed by azathioprine 2mg/kg/day po plus corticosteroids for the following 24 weeks. Response rate will be assessed at the end of the induction phase, and at the end of study. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Enrollment: 52 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients, 18-75 years of age;
• systemic lupus erythematosus;
• histological diagnosis of lupus nephritis.

Exclusion criteria

• not in need of immunosuppressive treatment (in addition to corticosteroids);
• continuous dialysis starting >2 weeks before randomization, with an anticipated duration of >8 weeks;
• previous or planned kidney transplant.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

Mycophenolate Mofetil

Experimental group

Description:

Participants received mycophenolate mofetil (MMF) 0.5 grams (g), orally (PO), twice daily (BID) from Day 0 to the end of Week 1, followed by 1.0 g, PO, BID from Weeks 2 through 24, and 0.75 g, PO, BID from Weeks 32 to 48. Participants also received prednisolone 0.75 to 1.0 milligrams per kilogram (mg/kg), PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reaches 40 mg per day, followed by a reduction of 5 mg per day every 2 weeks until dose reaches 10 mg per day up to Week 48.

Treatment:

Drug: Mycophenolate Mofetil

Drug: Corticosteroids

Cyclophosphamide/Azathioprine

Active Comparator group

Description:

Participants received cyclophosphamide 0.75 grams per square meter (g/m\^2), intravenously (IV), every 4 weeks from Weeks 1 through 4, and 0.5 to (-) 1.0 g/m\^2, IV, to maintain a minimum white blood cell (WBC) count of greater than or equal to (≥) 2500 per cubic millimeter (mm\^3) every 4 weeks from Weeks 5 through 24. Participants also received azathioprine 100 mg, PO, daily for participants with a body weight of 50 to 70 kg and 150 mg, PO, daily for subjects with a body weight of more than 70 kg from Weeks 25 through 48. Participants also received prednisolone 0.75 to 1.0 mg/kg, PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reaches 40 mg per day, followed by a reduction of 5 mg per day every 2 weeks until dose reaches 10 mg per day up to Week 48.

Treatment:

Drug: Cyclophosphamide

Drug: Corticosteroids

Drug: Azathioprine