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

January 22, 2007
October 7, 2013
March 2007
April 2008   (final data collection date for primary outcome measure)
Complete remission rate [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
Complete remission rate at end of study (proteinuria <500mg/24h, stable serum creatinine within +/-25% of baseline serum creatinine, or improved).
Complete list of historical versions of study NCT00425438 on ClinicalTrials.gov Archive Site
  • 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 ]
Efficacy: Rate of response in induction phase, time to complete remission at end of maintenance phase, renal function, discontinuations, time to treatment failure. Safety: Laboratory tests, AEs.
Not Provided
Not Provided
 
A Study of CellCept (Mycophenolate Mofetil) in Patients With Lupus Nephritis.
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Lupus Nephritis
  • 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
  • Drug: Azathioprine
    2mg/kg /day po during weeks 24-48
  • Drug: Cyclophosphamide
    0.5-1.0g/m2 monthly for 24 weeks
  • Experimental: 1
    Interventions:
    • Drug: mycophenolate mofetil [CellCept]
    • Drug: Corticosteroids
  • Active Comparator: 2
    Interventions:
    • Drug: Corticosteroids
    • Drug: Azathioprine
    • Drug: Cyclophosphamide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
59
April 2008
April 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00425438
ML19978
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP