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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Frédéric A. Houssiau, MD, PhD, Université Catholique de Louvain
ClinicalTrials.gov Identifier:
NCT00204022
First received: September 12, 2005
Last updated: October 13, 2011
Last verified: October 2011

September 12, 2005
October 13, 2011
February 2001
August 2011   (final data collection date for primary outcome measure)
Time to renal flare [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Time to renal flare
Complete list of historical versions of study NCT00204022 on ClinicalTrials.gov Archive Site
  • Number of withdrawals due to toxicity [ Time Frame: 5 years and 10 years ] [ Designated as safety issue: No ]
  • Cumulated glucocorticoid intake [ Time Frame: 5 years and 10 years ] [ Designated as safety issue: No ]
  • Number of treatment failures [ Time Frame: 5 years and 10 years ] [ Designated as safety issue: No ]
  • 24-hour proteinuria over time [ Time Frame: 5 years and 10 years ] [ Designated as safety issue: No ]
  • Serum creatinine titers [ Time Frame: 5 years and 10 years ] [ Designated as safety issue: No ]
  • Time to renal flare [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Number of withdrawals due to toxicity
  • Cumulated glucocorticoid intake
  • Number of treatment failures
  • 24-hour proteinuria over time
  • Renal function over time
Not Provided
Not Provided
 
Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy of Lupus Nephritis.
A Randomized Multicenter Trial Comparing Mycophenolate Mofetil and Azathioprine as Remission-maintaining Treatment for Proliferative Lupus Glomerulonephritis. The MAINTAIN Nephritis Trial.

The purpose of the study is to determine whether mycophenolate mofetil is superior to azathioprine to prevent flares of lupus nephritis.

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.

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
    Mycophenolate mofetil
  • Drug: Azathioprine
    Azathioprine
  • Experimental: 1
    Mycophenolate mofetil (target dose 2g/day)
    Intervention: Drug: Mycophenolate mofetil
  • Active Comparator: 2
    Azathioprine (target dose 2mg/kg/day)
    Intervention: Drug: Azathioprine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
105
August 2011
August 2011   (final data collection date for primary outcome measure)

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
Both
14 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00204022
EWPSLE-LN-02
No
Frédéric A. Houssiau, MD, PhD, Université Catholique de Louvain
Frédéric A. Houssiau, MD, PhD
Not Provided
Principal Investigator: Frédéric A Houssiau, MD, PhD Université Catholique de Louvain
Université Catholique de Louvain
October 2011

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