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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

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

ClinicalTrials.gov Identifier:

NCT00204022

First received: September 12, 2005

Last updated: October 13, 2011

Last verified: October 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

October 13, 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
Cumulated glucocorticoid intake [ Time Frame: 5 years and 10 years ] [ Designated as safety issue: No ]
Number of treatment failures [ Time Frame: 5 years and 10 years ] [ Designated as safety issue: No ]
24-hour proteinuria over time [ Time Frame: 5 years and 10 years ] [ Designated as safety issue: No ]
Serum creatinine titers [ Time Frame: 5 years and 10 years ] [ Designated as safety issue: No ]
Time to renal flare [ Time Frame: 10 years ] [ Designated as safety issue: No ]

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

Condition ^ICMJE

Lupus Nephritis

Intervention ^ICMJE

Drug: Mycophenolate mofetil
Mycophenolate mofetil
Drug: Azathioprine
Azathioprine

Study Arm (s)

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 *

Not Provided

* 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

Gender

Both

Ages

14 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Belgium

Administrative Information

NCT Number ^ICMJE

NCT00204022

Other Study ID Numbers ^ICMJE

EWPSLE-LN-02

Has Data Monitoring Committee

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

Information Provided By

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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