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

Condition(s) targeted: Lupus Nephritis

Intervention: mycophenolate mofetil [CellCept] (Drug); Cyclophosphamide (Drug); mycophenolate mofetil [CellCept] (Drug); Azathioprine (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche, +1 973 235 5000

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.

Official 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

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

Number of patients showing treatment response

Time to treatment failure

Secondary outcome:

Complete/partial remission, serum creatinine, urine protein, serum albumin, BILAG, SF36.

Time to death, ESRD, doubling of serum creatinine, renal and extrarenal flare, rescue therapy.

Minimum age: 12 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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.

CÓRDOBA 5016, Argentina

BUENOS AIRES C1425DQK, Argentina

TUCUMAN 4000, Argentina

BUENOS AIRES C1015ABO, Argentina

Ciudad Autonoma de Buenos Aires, Argentina

Florida, Argentina

La Plata, Argentina

Melbourne, Australia

BRUXELLES 1200, Belgium

RIO DE JANEIRO 20551-030, Brazil

SOROCABA 18030-210, Brazil

SAO PAULO 04039-020, Brazil

SHANGHAI 200001, China

GUANGZHOU 510630, China

BEIJING 100034, China

Nanjing, China

San Jose, Costa Rica

PRAHA 128 08, Czech Republic

PARIS 75014, France

LILLE 59037, France

LYON 69437, France

PARIS 75018, France

TOULOUSE 31059, France

AACHEN 52074, Germany

BERLIN 10117, Germany

Dusseldorf, Germany

Erlangen, Germany

ATHENS 11527, Greece

ATHENS 11521, Greece

PADOVA 35128, Italy

Batu Caves, Malaysia

Kuala Lumpur, Malaysia

Penang, Malaysia

SAN LUIS POTOSI 78240, Mexico

MEXICO CITY 14000, Mexico

LISBOA, Portugal

PORTO 4200-319, Portugal

Cape Town, South Africa

Johannesburg, South Africa

Soweto, South Africa

BARCELONA 08036, Spain

MALAGA 29010, Spain

BARCELONA 08035, Spain

SEVILLA 41013, Spain

LONDON SE1 7EH, United Kingdom

LEEDS LS1 3EX, United Kingdom

LONDON W12 OHS, United Kingdom

HUNTSVILLE, Alabama 35801, United States

Birmingham, Alabama, United States

TORRANCE, California 90502, United States

LOS ANGELES, California 90095, United States

SAN LEANDRO, California 94578, United States

Long Beach, California, United States

MIAMI, Florida 33136, United States

ATLANTA, Georgia 30303, United States

CHICAGO, Illinois 60611, United States

Des Moines, Iowa, United States

BALTIMORE, Maryland 21205, United States

Boston, Massachusetts, United States

Newark, New Jersey, United States

NEW YORK, New York 10032, United States

NEW YORK, New York 10003, United States

LAKE SUCCESS, New York 11042, United States

BROOKLYN, New York 11203, United States

CHAPEL HILL, North Carolina 27599-7280, United States

COLUMBUS, Ohio 43210, United States

Portland, Oregon, United States

PITTSBURGH, Pennsylvania 15213, United States

MONTREAL, Quebec H1T 2M4, Canada

CHARLESTON, South Carolina 29425, United States

DALLAS, Texas 75390, United States

San Antonio, Texas, United States

Starting date: July 2005
Ending date: June 2009
Last updated: June 17, 2008