Trial information

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

Status: No longer recruiting

Protocol number: WX17801

Sponsor: Hoffmann-La Roche; Aspreva Pharmaceuticals Corporation

Company division: Pharmaceutical

Official Scientific Title: A randomized, double-blind study to evaluate the safety and efficacy of CellCept on treatment response and maintenance of remission in patients with lupus nephritis

Brief summary: This 2 arm study will assess the efficacy of CellCept compared to cyclophosphamide in inducing a response in patients with lupus nephritis, and the long term efficacy of CellCept compared to azathioprine in maintaining remission and renal function. Patients will be randomized to receive either CellCept (1.5g bid) or cyclophosphamide (0.5-1.0g/m2 in monthly pulses) in the induction phase. Those patients meeting criteria for response will be re-randomized for entry into the maintenance phase, to receive either CellCept (1g bid) or azathioprine (2mg/kg/day). The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals. Target sample size is 358.

Study phase: III

Study type: Interventional; Treatment; Randomized; Double Blind; Active; Parallel; Safety/Efficacy study

Condition: Lupus Nephritis

Intervention type: Drug

Intervention name: mycophenolate mofetil [CellCept]

Primary outcome: 1. Number of patients showing treatment response Time frame: 24 weeks 2. Time to treatment failure Time frame: 24-48 weeks

Key secondary outcomes: 1. Complete/partial remission, serum creatinine, urine protein, serum albumin, BILAG, SF36. Time frame: 24 weeks 2. Time to death, ESRD, doubling of serum creatinine, renal and extrarenal flare, rescue therapy. Time frame: 24-48 weeks

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.

Gender: Males or Females

Age limits: Min: 12 Years Max: 75 Years

Accepts healthy volunteers: No

Anticipated start date: July, 2005

Trial registration date: 09/18/2006

Date last updated: 8/29/2008

Link to trial result

This trial was conducted at the following locations:

Argentina

• Buenos Aires
• Ciudad Autónoma De Bs. As.
• Córdoba
• Florida
• La Plata
• Tucuman

Australia

• Melbourne

Belgium

• Bruxelles

Brazil

• Rio De Janeiro
• Sao Paulo
• Sorocaba

Canada

• Montreal, QC

China

• Beijing
• Guangzhou
• Nanjing
• Shanghai

Costa Rica

• San Jose

Czech Republic

• Praha

France

• Lille
• Lyon
• Paris
• Toulouse

Germany

• Aachen
• Berlin
• Düsseldorf
• Erlangen

Greece

• Athens

Italy

• Padova

Malaysia

• Batu Caves
• Kuala Lumpur
• Penang

Mexico

• Mexico City
• San Luis Potosi

Portugal

• Lisboa
• Porto

South Africa

• Cape Town
• Johannesburg
• Soweto

Spain

• Barcelona
• Malaga
• Sevilla

United Kingdom

• Leeds
• London

United States

• Birmingham, AL
• Huntsville, AL
• Long Beach, CA
• Los Angeles, CA
• San Leandro, CA
• Torrance , CA
• Miami, FL
• Atlanta, GA
• Chicago, IL
• Des Moines, IA
• Baltimore, MD
• Boston, MA
• Newark, NJ
• Brooklyn, NY
• Lake Success, NY
• New York, NY
• Chapel Hill, NC
• Columbus, OH
• Portland, OR
• Pittsburgh, PA
• Charleston, SC
• Dallas, TX
• San Antonio, TX