Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy of Lupus Nephritis.

Lupus Nephritis Clinical Trial

— MAINTAIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00204022
• Other study ID #: EWPSLE-LN-02
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: October 13, 2011
• Start date: February 2001
• Est. completion date: August 2011

Study information

• Verified date: October 2011
• Source: Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ministry of Social Affairs, Public Health and the Environment
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Lupus Nephritis
• Nephritis

Intervention

Drug:
• Mycophenolate mofetil
Mycophenolate mofetil
• Azathioprine
Azathioprine

Locations

Country	Name	City	State
Belgium	Université catholique de Louvain	Bruxelles

Sponsors (1)

Lead Sponsor	Collaborator
Frédéric A. Houssiau, MD, PhD

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to renal flare		5 years	No
Secondary	Number of withdrawals due to toxicity		5 years and 10 years	No
Secondary	Cumulated glucocorticoid intake		5 years and 10 years	No
Secondary	Number of treatment failures		5 years and 10 years	No
Secondary	24-hour proteinuria over time		5 years and 10 years	No
Secondary	Serum creatinine titers		5 years and 10 years	No
Secondary	Time to renal flare		10 years	No