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

This study has been terminated.
(Study was terminated early for administrative reasons.)
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00425438
First received: January 22, 2007
Last updated: September 22, 2014
Last verified: September 2014

January 22, 2007
September 22, 2014
March 2007
April 2008   (final data collection date for primary outcome measure)
Complete Response (CR) by the End of Treatment - Percentage of Participants With an Event [ Time Frame: Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48 ] [ Designated as safety issue: No ]
CR was defined as a urinary protein value of less than (<) 500 mg per 24 hours (mg/24h) and no hematuria or cellular casts in the urine, and a stable serum creatinine value within the range of plus or minus (±) 25 percent (%) of baseline (BL) or some improvement.
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
  • Complete Response [ Time Frame: Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48 ] [ Designated as safety issue: No ]
    The median time, in months, to CR was defined as the time from randomization to CR event.
  • Percentage of Participants With Treatment Response Event by End of Treatment [ Time Frame: Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48 ] [ Designated as safety issue: No ]
    Treatment response was defined by a reduction in the ratio of urine protein to creatinine to <3 mg/mg for participants with nephrotic proteinuria and a decrease of more than 50% in their urine protein to creatinine value from BL for participants with non-nephrotic proteinuria; a stable serum creatinine value or an increase of more than 30% from BL; and having not received IV prednisone after Week 28.
  • Percentage of Participants With a Decrease of 25% or 50% in Glomerular Filtration Rate (GFR) [ Time Frame: Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48 ] [ Designated as safety issue: No ]
    GFR was calculated according to the simplified modification of diet in renal disease (MDRD) formula.
  • Percentage of Participants Terminating Treatment [ Time Frame: Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48 ] [ Designated as safety issue: No ]
  • Time to Treatment Failure [ Time Frame: Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48 ] [ Designated as safety issue: No ]
    Treatment failure was defined as the occurrence of any of the following: death; chronic renal failure requiring dialysis or kidney transplantation; an increase in average serum creatinine values by 2-fold for 2 consecutive measures from BL, and a increase by 2-fold for 2 consecutive measures in at least 4 weeks; recurrent kidney disease defined by, proteinuria, a doubling in the ratio of urine protein to creatinine from BL and a urinary protein value of <0.5 g/24h or greater than (>) 1 g/24h or >0.5 g/24h or >2 g/24h at Week 24, kidney disease, defined by an increase in serum creatinine of 25% from BL along with a doubling of urinary protein of at least 2 g/24h, and hematuria, 2 or more blood cells per urine dipstick test.
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
    0.5 g PO BID from Day 0 to the end of Week 1, followed by 1.0 g PO BID from Weeks 2 through 24, and 0.75 g PO BID from Weeks 32 to 48
    Other Name: CellCept
  • Drug: Corticosteroids
    0.75 to 1.0 mg/kg/d PO (up to 60 kg/day) from Weeks 1 through 4; reduced by 10 mg/day every 2 weeks until dose reaches 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reaches 10 mg/day up to Week 48
    Other Name: Prednisolone
  • Drug: Azathioprine
    100 mg PO daily for participants with a body weight of 50 to 70 kg,150 mg PO daily for subjects with a body weight of more than 70 kg up to Week 48
  • Drug: Cyclophosphamide
    0.75 g/m^2 IV every 4 weeks from Weeks 1 through 4, and 0.5-1.0 g/m^2 to maintain a minimum WBC count of ≥ 2500 per mm^3 from Weeks 5 through 24
  • Experimental: Mycophenolate Mofetil
    Participants received mycophenolate mofetil (MMF) 0.5 grams (g), orally (PO), twice daily (BID) from Day 0 to the end of Week 1, followed by 1.0 g, PO, BID from Weeks 2 through 24, and 0.75 g, PO, BID from Weeks 32 to 48. Participants also received prednisolone 0.75 to 1.0 milligrams per kilogram (mg/kg), PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reaches 40 mg per day, followed by a reduction of 5 mg per day every 2 weeks until dose reaches 10 mg per day up to Week 48.
    Interventions:
    • Drug: Mycophenolate Mofetil
    • Drug: Corticosteroids
  • Active Comparator: Cyclophosphamide/Azathioprine
    Participants received cyclophosphamide 0.75 grams per square meter (g/m^2), intravenously (IV), every 4 weeks from Weeks 1 through 4, and 0.5 to (-) 1.0 g/m^2, IV, to maintain a minimum white blood cell (WBC) count of greater than or equal to (≥) 2500 per cubic millimeter (mm^3) every 4 weeks from Weeks 5 through 24. Participants also received azathioprine 100 mg, PO, daily for participants with a body weight of 50 to 70 kg and 150 mg, PO, daily for subjects with a body weight of more than 70 kg from Weeks 25 through 48. Participants also received prednisolone 0.75 to 1.0 mg/kg, PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reaches 40 mg per day, followed by a reduction of 5 mg per day every 2 weeks until dose reaches 10 mg per day up to Week 48.
    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.
 
Terminated
52
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
September 2014

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