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Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy of Lupus Nephritis. (MAINTAIN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00204022
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : October 14, 2011
Sponsor:
Information provided by (Responsible Party):
Frédéric A. Houssiau, MD, PhD, Université Catholique de Louvain

Tracking Information
First Submitted Date  ICMJE September 12, 2005
First Posted Date  ICMJE September 20, 2005
Last Update Posted Date October 14, 2011
Study Start Date  ICMJE February 2001
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 17, 2011)
Time to renal flare [ Time Frame: 5 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
Time to renal flare
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 17, 2011)
  • Number of withdrawals due to toxicity [ Time Frame: 5 years and 10 years ]
  • Cumulated glucocorticoid intake [ Time Frame: 5 years and 10 years ]
  • Number of treatment failures [ Time Frame: 5 years and 10 years ]
  • 24-hour proteinuria over time [ Time Frame: 5 years and 10 years ]
  • Serum creatinine titers [ Time Frame: 5 years and 10 years ]
  • Time to renal flare [ Time Frame: 10 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
  • Number of withdrawals due to toxicity
  • Cumulated glucocorticoid intake
  • Number of treatment failures
  • 24-hour proteinuria over time
  • Renal function over time
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy of Lupus Nephritis.
Official Title  ICMJE A Randomized Multicenter Trial Comparing Mycophenolate Mofetil and Azathioprine as Remission-maintaining Treatment for Proliferative Lupus Glomerulonephritis. The MAINTAIN Nephritis Trial.
Brief Summary The purpose of the study is to determine whether mycophenolate mofetil is superior to azathioprine to prevent flares of lupus nephritis.
Detailed Description Proliferative glomerulonephritis is a common and severe manifestation of systemic lupus erythematosus (SLE) that usually requires intensive therapy with high doses of glucocorticosteroids and cytotoxic drugs, such as intravenous (IV) cyclophosphamide (CYC). The objective of the MAINTAIN Nephritis Trial is to compare mycophenolate mofetil (MMF) and azathioprine (AZA), in terms of efficacy and toxicity, as remission-maintaining treatment of proliferative lupus glomerulonephritis, after a remission-inducing therapy with a short-course IV CYC regimen. The hypothesis addressed by the MAINTAIN Nephritis Trial is that MMF is superior to AZA.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lupus Nephritis
Intervention  ICMJE
  • Drug: Mycophenolate mofetil
    Mycophenolate mofetil
  • Drug: Azathioprine
    Azathioprine
Study Arms  ICMJE
  • Experimental: 1
    Mycophenolate mofetil (target dose 2g/day)
    Intervention: Drug: Mycophenolate mofetil
  • Active Comparator: 2
    Azathioprine (target dose 2mg/kg/day)
    Intervention: Drug: Azathioprine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 8, 2011)
105
Original Enrollment  ICMJE
 (submitted: September 12, 2005)
102
Actual Study Completion Date  ICMJE August 2011
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • SLE aged ≥ 14 years
  • Proteinuria ≥ 500 mg/day
  • Biopsy-proven proliferative lupus nephritis

Exclusion Criteria:

  • Recent treatment with high-dose glucocorticoids
  • Recent treatment with immunosuppressive drugs
  • More exclusion criteria in the protocol
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00204022
Other Study ID Numbers  ICMJE EWPSLE-LN-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Frédéric A. Houssiau, MD, PhD, Université Catholique de Louvain
Study Sponsor  ICMJE Frédéric A. Houssiau, MD, PhD
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Frédéric A Houssiau, MD, PhD Université Catholique de Louvain
PRS Account Université Catholique de Louvain
Verification Date October 2011

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