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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
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Université Catholique de Louvain:

Primary Outcome Measures:
  • Time to renal flare [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: September 12, 2005
Last Updated: October 13, 2011
Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment

Keywords provided by Université Catholique de Louvain:
Lupus nephritis
Treatment
Maintenance therapy
Mycophenolate mofetil
Azathioprine

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

ClinicalTrials.gov processed this record on June 17, 2013