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

Show 108 Study Locations

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