A Study of CellCept (Mycophenolate Mofetil) in Management of Patients With Lupus Nephritis. - Full Text View

Sponsor:	Hoffmann-La Roche
Collaborator:	Aspreva Pharmaceuticals
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00377637

Purpose

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.

Condition	Intervention	Phase
Lupus Nephritis	Drug: mycophenolate mofetil [CellCept] Drug: Cyclophosphamide Drug: Azathioprine	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Prospective, Randomized, Active Controlled, Parallel Group, Multi-center Trial to Assess the Efficacy and Safety of Mycophenolate Mofetil (MMF) in Inducing Response and Maintaining Remission in Subjects With Lupus Nephritis.

Resource links provided by NLM:

Drug Information available for: Cyclophosphamide Azathioprine sodium salt Mycophenolate mofetil hydrochloride Mycophenolate Mofetil Azathioprine

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Number of patients showing treatment response [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Time to treatment failure [ Time Frame: 24-48 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Complete/partial remission, serum creatinine, urine protein, serum albumin, BILAG, SF36. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Time to death, ESRD, doubling of serum creatinine, renal and extrarenal flare, rescue therapy. [ Time Frame: 24-48 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	358
Study Start Date:	July 2005
Estimated Study Completion Date:	June 2009

Arms	Assigned Interventions
1: Experimental	Drug: mycophenolate mofetil [CellCept] 1.5g po bid (induction) Drug: mycophenolate mofetil [CellCept] 1.0g po bid (maintenance)
2: Active Comparator	Drug: Cyclophosphamide 0.5-1.0g/m2 monthly (induction) Drug: Azathioprine 2mg/kg/day po (maintenance)

Eligibility

Ages Eligible for Study:	12 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00377637

Hide Study Locations

Locations

United States, Alabama

HUNTSVILLE, Alabama, United States, 35801
United States, California

TORRANCE, California, United States, 90502

LOS ANGELES, California, United States, 90095

SAN FRANCISCO, California, United States, 94143

SAN LEANDRO, California, United States, 94578

LA JOLLA, California, United States, 92037
United States, Florida

MIAMI, Florida, United States, 33136
United States, Georgia

ATLANTA, Georgia, United States, 30303
United States, Illinois

CHICAGO, Illinois, United States, 60611

CHICAGO, Illinois, United States, 60637
United States, Maryland

BALTIMORE, Maryland, United States, 21205
United States, Massachusetts

BOSTON, Massachusetts, United States, 02115
United States, Michigan

ANN ARBOR, Michigan, United States, 48109-0358
United States, Missouri

COLUMBIA, Missouri, United States, 65212
United States, New York

NEW YORK, New York, United States, 10032

NEW YORK, New York, United States, 10003

NEW YORK, New York, United States, 10021

NEW YORK, New York, United States, 10032

BROOKLYN, New York, United States, 11203

LAKE SUCCESS, New York, United States, 11042
United States, North Carolina

CHAPEL HILL, North Carolina, United States, 27599-7280

DURHAM, North Carolina, United States, 27710
United States, Ohio

CLEVELAND, Ohio, United States, 44136

COLUMBUS, Ohio, United States, 43210
United States, Oklahoma

OKLAHOMA CITY, Oklahoma, United States, 73104
United States, Pennsylvania

PHILADELPHIA, Pennsylvania, United States, 19104

PITTSBURGH, Pennsylvania, United States, 15213
United States, South Carolina

CHARLESTON, South Carolina, United States, 29425
United States, Texas

DALLAS, Texas, United States, 75390
Argentina

CÓRDOBA, Argentina, 5016

BUENOS AIRES, Argentina, C1425DQK

SAN ISIDRO, Argentina, B1602BPPD

BUENOS AIRES, Argentina, C1015ABO

TUCUMAN, Argentina, 4000
Australia

MELBOURNE, Australia, 3168

PARKVILLE, Australia, 3052

ADELAIDE, Australia, SA 5000

ADELAIDE, Australia, 5011

SYDNEY, Australia, 2050
Belgium

LEUVEN, Belgium, 3000

BRUXELLES, Belgium, 1200

LIEGE, Belgium, 4000
Brazil

RIO DE JANEIRO, Brazil, 20551-030

SOROCABA, Brazil, 18030-210

SAO PAULO, Brazil, 04039-020
Canada, British Columbia

VANCOUVER, British Columbia, Canada, V5Z 1L7
Canada, Nova Scotia

HALIFAX, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario

TORONTO, Ontario, Canada, M5T 2S8

LONDON, Ontario, Canada, N6A 4V2
Canada, Quebec

MONTREAL, Quebec, Canada, H1T 2M4
China

SHANGHAI, China, 200001

GUANGZHOU, China, 510630

JIANGSU, China, 210002

GUANGDONG, China, 510008

BEIJING, China, 100034
Czech Republic

PRAHA, Czech Republic, 128 08

BRNO, Czech Republic, 656 91
France

NANTES, France, 44093

LYON, France, 69437

LILLE, France, 59037

PARIS, France, 75014

PARIS, France, 75018

TOULOUSE, France, 31059
Germany

BERLIN, Germany, 14059

MÜNCHEN, Germany, 80336

LEIPZIG, Germany, 04103

MUENSTER, Germany, 48149

AACHEN, Germany, 52074

MÜNCHEN, Germany, 81675

BAD BRAMSTEDT, Germany, 24576

BERLIN, Germany, 10117

ERLANGEN, Germany, 91058

HANNOVER, Germany, 30625

DRESDEN, Germany, 01307

DÜSSELDORF, Germany, 40225
Greece

ATHENS, Greece, 11527

HERAKLION, Greece, 71500

ATHENS, Greece, 11521
Hungary

PÉCS, Hungary, 7632

SZEGED, Hungary, 2724

DEBRECEN, Hungary, 4004
Italy

PISA, Italy, 56100

UDINE, Italy, 33100

PADOVA, Italy, 35128

MILANO, Italy, 20149

BRESCIA, Italy, 25125
Mexico

MERIDA, Mexico, 97000

SAN LUIS POTOSI, Mexico, 78240

MEXICO CITY, Mexico, 14000
Portugal

LISBOA, Portugal

PORTO, Portugal, 4200-319
Spain

BARCELONA, Spain, 08036

BARCELONA, Spain, 08035

MALAGA, Spain, 29010

MADRID, Spain, 28041

SANTANDER, Spain, 39008

ALICANTE, Spain, 03010

SEVILLA, Spain, 41013
United Kingdom

LONDON, United Kingdom, WIT 4NJ

LONDON, United Kingdom, SE1 7EH

BIRMINGHAM, United Kingdom, B15 2TT

LEEDS, United Kingdom, LS1 3EX

SHEFFIELD, United Kingdom, S10 2JF

MANCHESTER, United Kingdom, M13 9WL

SOUTHAMPTON, United Kingdom, SO16 6YD

NEWCASTLE UPON TYNE, United Kingdom, NE7 7DN

CAMBRIDGE, United Kingdom, CB2 2QQ

LONDON, United Kingdom, W12 OHS

Sponsors and Collaborators

Hoffmann-La Roche

Aspreva Pharmaceuticals

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	WX17801
Study First Received:	September 15, 2006
Last Updated:	August 26, 2009
ClinicalTrials.gov Identifier:	NCT00377637 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Antimetabolites
Glomerulonephritis
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Lupus Nephritis
Antineoplastic Agents
Physiological Effects of Drugs
Mycophenolic Acid
Cyclophosphamide
Antibiotics, Antineoplastic
Azathioprine
Lupus Erythematosus, Systemic
Urologic Diseases

Therapeutic Uses
Mycophenolate mofetil
Connective Tissue Diseases
Kidney Diseases
Alkylating Agents
Autoimmune Diseases
Immune System Diseases
Enzyme Inhibitors
Immunosuppressive Agents
Pharmacologic Actions
Nephritis
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents

ClinicalTrials.gov processed this record on November 27, 2009