Skip to main content
OpenTrials
Completed

NCT Number: NCT00204022

Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy of Lupus Nephritis.

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Lupus Nephritis Autoimmune Diseases Connective Tissue Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glomerulonephritis Immune System Diseases Kidney Diseases Lupus Erythematosus, Systemic Male Urogenital Diseases Nephritis Skin and Connective Tissue Diseases Urogenital Diseases Urologic Diseases

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Université catholique de Louvain

Brussels, B-1200, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mycophenolate mofetil

Drug

Mycophenolate mofetil

azathioprine

Drug

Azathioprine

Primary outcomes

  1. Time to renal flare

    Time frame: 5 years

Secondary outcomes

  1. Number of withdrawals due to toxicity

    Time frame: 5 years and 10 years

  2. Cumulated glucocorticoid intake

    Time frame: 5 years and 10 years

  3. Number of treatment failures

    Time frame: 5 years and 10 years

  4. 24-hour proteinuria over time

    Time frame: 5 years and 10 years

  5. Serum creatinine titers

    Time frame: 5 years and 10 years

  6. Time to renal flare

    Time frame: 10 years

Sponsors and collaborators

Lead sponsor

Frédéric A. Houssiau, MD, PhD

Other

Registry information

Official study title

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

Acronym: MAINTAIN

Important dates

Study start
2001
Primary completion
2011
Study completion
2011
First posted
Sep 20, 2005
Registry last updated
Oct 14, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.