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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00425438
First received: January 22, 2007
Last updated: October 7, 2013
Last verified: October 2013
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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:


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 Start Date: March 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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
Active Comparator: 2 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
China
Beijing, China, 100853
Beijing, China, 100005
Beijing, China, 100029
Guangzhou, China, 510515
Guangzhou, China, 510080
Hangzhou, China, 310003
Nanjing, China, 210008
Shanghai, China, 200025
Shanghai, China, 200001
Shanghai, China, 200003
Shenyang, China, 110001
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00425438     History of Changes
Other Study ID Numbers: ML19978
Study First Received: January 22, 2007
Last Updated: October 7, 2013
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Lupus Nephritis
Nephritis
Glomerulonephritis
Kidney Diseases
Urologic Diseases
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Azathioprine
Cyclophosphamide
Mycophenolate mofetil
Mycophenolic Acid
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 22, 2014