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

Sponsors and Collaborators:	Hoffmann-La Roche 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

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
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

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

Show 119 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Aspreva Pharmaceuticals

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	WX17801
Study First Received:	September 15, 2006
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00377637
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Glomerulonephritis
Azathioprine
Autoimmune Diseases
Lupus Erythematosus, Systemic
Urologic Diseases
Lupus Nephritis

Nephritis
Mycophenolic Acid
Mycophenolate mofetil
Connective Tissue Diseases
Cyclophosphamide
Kidney Diseases

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors

Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions
Therapeutic Uses
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Alkylating Agents

ClinicalTrials.gov processed this record on January 15, 2009