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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00204022
First Posted: September 20, 2005
Last Update Posted: October 14, 2011
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.
Information provided by (Responsible Party):
Frédéric A. Houssiau, MD, PhD, Université Catholique de Louvain
  Purpose
The purpose of the study is to determine whether mycophenolate mofetil is superior to azathioprine to prevent flares of lupus nephritis.

Condition Intervention Phase
Lupus Nephritis Drug: Mycophenolate mofetil Drug: Azathioprine Phase 3

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Frédéric A. Houssiau, MD, PhD, Université Catholique de Louvain:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 105
Study Start Date: February 2001
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Mycophenolate mofetil (target dose 2g/day)
Drug: Mycophenolate mofetil
Mycophenolate mofetil
Active Comparator: 2
Azathioprine (target dose 2mg/kg/day)
Drug: Azathioprine
Azathioprine

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00204022


Locations
Belgium
Université catholique de Louvain
Bruxelles, Belgium, B-1200
Sponsors and Collaborators
Frédéric A. Houssiau, MD, PhD
Investigators
Principal Investigator: Frédéric A Houssiau, MD, PhD Université Catholique de Louvain
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Frédéric A. Houssiau, MD, PhD, Professeur Ordinaire, Chef de Service Clinique, Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT00204022     History of Changes
Other Study ID Numbers: EWPSLE-LN-02
First Submitted: September 12, 2005
First Posted: September 20, 2005
Last Update Posted: October 14, 2011
Last Verified: October 2011

Keywords provided by Frédéric A. Houssiau, MD, PhD, Université Catholique de Louvain:
Lupus nephritis
Treatment
Maintenance therapy
Mycophenolate mofetil
Azathioprine

Additional relevant MeSH terms:
Nephritis
Lupus Nephritis
Kidney Diseases
Urologic Diseases
Glomerulonephritis
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Mycophenolic Acid
Mycophenolate mofetil
Azathioprine
Antibiotics, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antimetabolites
Antimetabolites, Antineoplastic
Antirheumatic Agents