Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

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. Identifier: NCT00204022
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : October 14, 2011
Information provided by (Responsible Party):
Frédéric A. Houssiau, MD, PhD, Université Catholique de Louvain

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

Condition or disease Intervention/treatment Phase
Lupus Nephritis Drug: Mycophenolate mofetil Drug: Azathioprine Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Multicenter Trial Comparing Mycophenolate Mofetil and Azathioprine as Remission-maintaining Treatment for Proliferative Lupus Glomerulonephritis. The MAINTAIN Nephritis Trial.
Study Start Date : February 2001
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Arm Intervention/treatment
Experimental: 1
Mycophenolate mofetil (target dose 2g/day)
Drug: Mycophenolate mofetil
Mycophenolate mofetil

Active Comparator: 2
Azathioprine (target dose 2mg/kg/day)
Drug: Azathioprine

Primary Outcome Measures :
  1. Time to renal flare [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Number of withdrawals due to toxicity [ Time Frame: 5 years and 10 years ]
  2. Cumulated glucocorticoid intake [ Time Frame: 5 years and 10 years ]
  3. Number of treatment failures [ Time Frame: 5 years and 10 years ]
  4. 24-hour proteinuria over time [ Time Frame: 5 years and 10 years ]
  5. Serum creatinine titers [ Time Frame: 5 years and 10 years ]
  6. Time to renal flare [ Time Frame: 10 years ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00204022

Layout table for location information
Université catholique de Louvain
Bruxelles, Belgium, B-1200
Sponsors and Collaborators
Frédéric A. Houssiau, MD, PhD
Layout table for investigator information
Principal Investigator: Frédéric A Houssiau, MD, PhD Université Catholique de Louvain
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Frédéric A. Houssiau, MD, PhD, Professeur Ordinaire, Chef de Service Clinique, Université Catholique de Louvain Identifier: NCT00204022    
Other Study ID Numbers: EWPSLE-LN-02
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: October 14, 2011
Last Verified: October 2011
Keywords provided by Frédéric A. Houssiau, MD, PhD, Université Catholique de Louvain:
Lupus nephritis
Maintenance therapy
Mycophenolate mofetil
Additional relevant MeSH terms:
Layout table for MeSH terms
Lupus Nephritis
Kidney Diseases
Urologic Diseases
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Mycophenolic Acid
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents