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

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00425438

Purpose

This 2 arm study will compare the efficacy and safety of CellCept plus corticosteroids, versus cyclophosphamide plus corticosteroids in the induction phase followed by azathioprine in the maintenance phase, in maintaining remission and renal function in patients with lupus nephritis. Patients will be randomized to receive CellCept 1g bid po plus corticosteroids for 24 weeks, followed by CellCept 0.75g bid po plus corticosteroids for the following 24 weeks, or cyclophosphamide 0.5-1.0g/m2 monthly plus corticosteroids for 24 weeks, followed by azathioprine 2mg/kg/day po plus corticosteroids for the following 24 weeks. Response rate will be assessed at the end of the induction phase, and at the end of study. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Open-Label Study to Compare the Effect of CellCept Plus Corticosteroids, and Cyclophosphamide Plus Corticosteroids Followed by Azathioprine, on Remission Rate in Patients With Lupus Nephritis

Resource links provided by NLM:

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

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Complete remission rate [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Rate of response in induction phase [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Time to complete remission [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
Renal function, discontinuations, time to treatment failure, AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment:	59
Study Completion Date:	May 2008

Arms	Assigned Interventions
1: Experimental	Drug: mycophenolate mofetil [CellCept] 1g po bid for 24 weeks, followed by 0.75g po bid for 24 weeks. Drug: Corticosteroids As prescribed for 48 weeks
2: Active Comparator	Drug: Corticosteroids As prescribed for 48 weeks Drug: Azathioprine 2mg/kg /day po during weeks 24-48 Drug: Cyclophosphamide 0.5-1.0g/m2 monthly for 24 weeks

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

adult patients, 18-75 years of age;
systemic lupus erythematosus;
histological diagnosis of lupus nephritis.

Exclusion Criteria:

not in need of immunosuppressive treatment (in addition to corticosteroids);
continuous dialysis starting >2 weeks before randomization, with an anticipated duration of >8 weeks;
previous or planned kidney transplant.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00425438

Locations

China

NANJING, China, 210008

SHANGHAI, China, 200025

SHANGHAI, China, 200001

SHANGHAI, China, 200003

BEIJING, China, 100853

BEIJING, China, 100029

HANGZHOU, China, 310003

GUANGZHOU, China, 510080

GUANGZHOU, China, 510080

BEIJING, China, 100005

GUANGZHOU, China, 510515

SHENYANG, China, 110001

Sponsors and Collaborators

Hoffmann-La Roche

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:	ML19978
Study First Received:	January 22, 2007
Last Updated:	May 13, 2009
ClinicalTrials.gov Identifier:	NCT00425438 History of Changes
Health Authority:	China: State Food and Drug Administration

Study placed in the following topic categories:

Antimetabolites
Glomerulonephritis
Autoimmune Diseases
Immunologic Factors
Lupus Nephritis
Lupus
Mycophenolic Acid
Cyclophosphamide
Immunosuppressive Agents
Anti-Bacterial Agents

Azathioprine
Urologic Diseases
Lupus Erythematosus, Systemic
Nephritis
Connective Tissue Diseases
Mycophenolate mofetil
Antineoplastic Agents, Alkylating
Kidney Diseases
Antirheumatic Agents
Alkylating Agents

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 September 02, 2009