NCT00204022

Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy of Lupus Nephritis.

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Frédéric A. Houssiau, MD, PhD · Academic / Other
• Sex: All
• Age: 14 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lupus Nephritis

Interventions

Type	Name	Description
DRUG	Mycophenolate mofetil	Mycophenolate mofetil
DRUG	Azathioprine	Azathioprine

Timeline

• Start date: 2001-02-01
• Primary completion: 2011-08-01
• Completion: 2011-08-01
• First posted: 2005-09-20
• Last updated: 2011-10-14

Locations

1 site across 1 country: Belgium