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 toxicityCumulated 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
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