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

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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

Study Description

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.

Study Design

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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

Resource links provided by the National Library of Medicine

Drug Information available for: Azathioprine Mycophenolic acid Mycophenolate sodium Azathioprine Sodium Mycophenolate mofetil hydrochloride Mycophenolate mofetil

Genetic and Rare Diseases Information Center resources: Glomerulonephritis Lupus Nephritis

U.S. FDA Resources

Arms and Interventions

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 Azathioprine

Outcome Measures

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 ]

Eligibility Criteria

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Ages Eligible for Study:	14 Years and older (Child, Adult, Older Adult)
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

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Belgium
Université catholique de Louvain
Bruxelles, Belgium, B-1200

Sponsors and Collaborators

Frédéric A. Houssiau, MD, PhD

Investigators

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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):

Tamirou F, Lauwerys BR, Dall'Era M, Mackay M, Rovin B, Cervera R, Houssiau FA; MAINTAIN Nephritis Trial Investigators. A proteinuria cut-off level of 0.7 g/day after 12 months of treatment best predicts long-term renal outcome in lupus nephritis: data from the MAINTAIN Nephritis Trial. Lupus Sci Med. 2015 Nov 12;2(1):e000123. doi: 10.1136/lupus-2015-000123. eCollection 2015.

Tamirou F, D'Cruz D, Sangle S, Remy P, Vasconcelos C, Fiehn C, Ayala Guttierez Mdel M, Gilboe IM, Tektonidou M, Blockmans D, Ravelingien I, le Guern V, Depresseux G, Guillevin L, Cervera R, Houssiau FA; MAINTAIN Nephritis Trial Group. Long-term follow-up of the MAINTAIN Nephritis Trial, comparing azathioprine and mycophenolate mofetil as maintenance therapy of lupus nephritis. Ann Rheum Dis. 2016 Mar;75(3):526-31. doi: 10.1136/annrheumdis-2014-206897. Epub 2015 Mar 10.

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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 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 Treatment Maintenance therapy Mycophenolate mofetil Azathioprine

Additional relevant MeSH terms:

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Nephritis Lupus Nephritis Kidney Diseases Urologic Diseases Glomerulonephritis Lupus Erythematosus, Systemic Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Mycophenolic Acid Azathioprine Antibiotics, Antineoplastic Antineoplastic Agents	Antibiotics, Antitubercular Antitubercular Agents Anti-Bacterial Agents Anti-Infective Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antimetabolites Antimetabolites, Antineoplastic Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents

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