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Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy of Lupus Nephritis.

Information source: Université Catholique de Louvain
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lupus Nephritis

Intervention: Mycophenolate mofetil (Drug); Azathioprine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Frédéric A. Houssiau, MD, PhD

Official(s) and/or principal investigator(s):
Frédéric A Houssiau, MD, PhD, Principal Investigator, Affiliation: Université Catholique de Louvain

Summary

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

Clinical Details

Official title: A Randomized Multicenter Trial Comparing Mycophenolate Mofetil and Azathioprine as Remission-maintaining Treatment for Proliferative Lupus Glomerulonephritis. The MAINTAIN Nephritis Trial.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Time to renal flare

Secondary outcome:

Number of withdrawals due to toxicity

Cumulated glucocorticoid intake

Number of treatment failures

24-hour proteinuria over time

Serum creatinine titers

Time to renal flare

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

Minimum age: 14 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

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

Starting date: February 2001
Last updated: October 13, 2011

Page last updated: August 23, 2015

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