Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy of Lupus Nephritis.

Phase 3

Completed

• Conditions: Lupus Nephritis
• Interventions: Drug: Mycophenolate mofetil; Drug: Azathioprine

• Registration Number: NCT00204022
• Lead Sponsor: Frédéric A. Houssiau, MD, PhD

Brief Summary

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

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 Timeline

• Study Start: 2001-02
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-20
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-13
• Last Update Posted: 2011-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Mycophenolate mofetil	Mycophenolate mofetil (target dose 2g/day)
2	Azathioprine	Azathioprine (target dose 2mg/kg/day)

Primary Outcome Measures

Name	Time	Method
Time to renal flare	5 years

Secondary Outcome Measures

Name	Time	Method
Number of treatment failures	5 years and 10 years
Time to renal flare	10 years
Number of withdrawals due to toxicity	5 years and 10 years
Cumulated glucocorticoid intake	5 years and 10 years
24-hour proteinuria over time	5 years and 10 years
Serum creatinine titers	5 years and 10 years

Trial Locations

Locations (1)

Université catholique de Louvain; 🇧🇪 Bruxelles, Belgium