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

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).

Conditions

• Lupus Nephritis

Interventions

DRUG

Mycophenolate mofetil (MMF)

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.

DRUG

Cyclophosphamide

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.

DRUG

Azathioprine

2 mg/kg/day orally, provided as 50 mg capsules to be taken after meals.

DRUG

Placebo to Azathioprine

Placebo capsules matching Azathioprine taken orally once a day.

DRUG

Placebo to Mycophenolate mofetil

Placebo tablets matching Mycophenolate mofetil taken orally twice daily.

DRUG

Corticosteroid

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.

Sponsors & Collaborators

• Aspreva Pharmaceuticals

  collaborator INDUSTRY

• Hoffmann-La Roche

  lead INDUSTRY

Principal Investigators

• Clinical Trials · Hoffmann-La Roche

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

12 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2005-07-31

Primary Completion

2007-03-31

Completion

2010-03-31

Countries

• United States
• Argentina
• Australia
• Belgium
• Brazil
• Canada
• China
• Czechia
• France
• Germany
• Greece
• Hungary
• Italy
• Mexico
• Portugal
• Spain
• United Kingdom

Study Locations