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

Roche

Status and phase: Completed; Phase 3

Conditions: Lupus Nephritis

Treatments: Drug: Placebo to Azathioprine; Drug: Corticosteroid; Drug: Placebo to Mycophenolate mofetil; Drug: Cyclophosphamide; Drug: Azathioprine; Drug: Mycophenolate mofetil (MMF)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00377637

WX17801

Details and patient eligibility

About

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).

Enrollment: 370 patients

Sex: All

Ages: 12 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• male or female patients, 12-75 years of age;
• diagnosis of systemic lupus erythematosus;
• kidney biopsy within 6 months of study, with histological diagnosis of lupus nephritis;
• laboratory evidence of active nephritis.

Exclusion criteria

• continuous dialysis starting >2 weeks before randomization into induction phase, and/or with an anticipated duration of >8 weeks;
• previous or planned kidney transplant;
• other clinically significant active medical conditions.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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370 participants in 4 patient groups

Induction Phase: Mycophenolate mofetil

Experimental group

Description:

Participants received oral mycophenolate mofetil (MMF) 1.5 g twice a day and concomitant corticosteroids for the 24 weeks of the Induction Phase.

Treatment:

Drug: Corticosteroid

Drug: Mycophenolate mofetil (MMF)

Induction Phase: Cyclophosphamide

Active Comparator group

Description:

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.

Treatment:

Drug: Corticosteroid

Drug: Cyclophosphamide

Maintenance Phase: Mycophenolate mofetil

Experimental group

Description:

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.

Treatment:

Drug: Corticosteroid

Drug: Mycophenolate mofetil (MMF)

Drug: Placebo to Azathioprine

Maintenance Phase: Azathioprine

Active Comparator group

Description:

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.

Treatment:

Drug: Corticosteroid

Drug: Azathioprine

Drug: Placebo to Mycophenolate mofetil