Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy of Lupus Nephritis. (MAINTAIN)

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00204022

First Posted: September 20, 2005

Last Update Posted: October 14, 2011

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Frédéric A. Houssiau, MD, PhD, Université Catholique de Louvain

Tracking Information

First Submitted Date ^ICMJE

September 12, 2005

First Posted Date ^ICMJE

September 20, 2005

Last Update Posted Date

October 14, 2011

Start Date ^ICMJE

February 2001

Primary Completion Date

August 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Time to renal flare [ Time Frame: 5 years ]

Original Primary Outcome Measures ^ICMJE

Time to renal flare

Change History

Complete list of historical versions of study NCT00204022 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Number of withdrawals due to toxicity
Cumulated glucocorticoid intake
Number of treatment failures
24-hour proteinuria over time
Renal function over time

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy of Lupus Nephritis.

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

Lupus Nephritis

Intervention ^ICMJE

Drug: Mycophenolate mofetil
Mycophenolate mofetil
Drug: Azathioprine
Azathioprine

Study Arms

Experimental: 1
Mycophenolate mofetil (target dose 2g/day)

Intervention: Drug: Mycophenolate mofetil
Active Comparator: 2
Azathioprine (target dose 2mg/kg/day)

Intervention: Drug: Azathioprine

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

105

Completion Date

August 2011

Primary Completion Date

August 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

14 Years and older (Child, Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Belgium

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00204022

Other Study ID Numbers ^ICMJE

EWPSLE-LN-02

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Frédéric A. Houssiau, MD, PhD, Université Catholique de Louvain

Study Sponsor ^ICMJE

Frédéric A. Houssiau, MD, PhD

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Frédéric A Houssiau, MD, PhD

Université Catholique de Louvain

PRS Account

Université Catholique de Louvain

Verification Date

October 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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