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Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy of Lupus Nephritis.

NCT ID: NCT00204022

Last Updated: 2011-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-02-28

Study Completion Date

2011-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Lupus Nephritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Mycophenolate mofetil (target dose 2g/day)

Group Type EXPERIMENTAL

Mycophenolate mofetil

Intervention Type DRUG

Mycophenolate mofetil

2

Azathioprine (target dose 2mg/kg/day)

Group Type ACTIVE_COMPARATOR

Azathioprine

Intervention Type DRUG

Azathioprine

Interventions

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Mycophenolate mofetil

Mycophenolate mofetil

Intervention Type DRUG

Azathioprine

Azathioprine

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Frédéric A. Houssiau, MD, PhD

OTHER

Sponsor Role lead

Responsible Party

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Frédéric A. Houssiau, MD, PhD

Professeur Ordinaire, Chef de Service Clinique

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Frédéric A Houssiau, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Université Catholique de Louvain

Locations

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Université catholique de Louvain

Brussels, , Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type DERIVED
PMID: 26629352 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25757867 (View on PubMed)

Other Identifiers

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EWPSLE-LN-02

Identifier Type: -

Identifier Source: org_study_id