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

Primary Purpose

Lupus Nephritis

Status

Completed

Phase

Phase 3

Locations

Belgium

Study Type

Interventional

Intervention

Mycophenolate mofetil

Azathioprine

About this trial

This is an interventional treatment trial for Lupus Nephritis focused on measuring Lupus nephritis, Treatment, Maintenance therapy, Mycophenolate mofetil, Azathioprine

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Université catholique de Louvain

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Mycophenolate mofetil (target dose 2g/day)

Azathioprine (target dose 2mg/kg/day)

Outcomes

Primary Outcome Measures

Time to renal flare

Secondary Outcome Measures

Number of withdrawals due to toxicity

Cumulated glucocorticoid intake

Number of treatment failures

24-hour proteinuria over time

Serum creatinine titers

Time to renal flare

Full Information

NCT ID

NCT00204022

First Posted

September 12, 2005

Last Updated

October 13, 2011

Sponsor

Frédéric A. Houssiau, MD, PhD

1. Study Identification

Unique Protocol Identification Number

NCT00204022

Brief Title

Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy of Lupus Nephritis.

Acronym

MAINTAIN

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2011

Overall Recruitment Status

Completed

Study Start Date

February 2001 (undefined)

Primary Completion Date

August 2011 (Actual)

Study Completion Date

August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Frédéric A. Houssiau, MD, PhD

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lupus Nephritis

Keywords

Lupus nephritis, Treatment, Maintenance therapy, Mycophenolate mofetil, Azathioprine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

105 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Mycophenolate mofetil (target dose 2g/day)

Arm Title

Arm Type

Active Comparator

Arm Description

Azathioprine (target dose 2mg/kg/day)

Intervention Type

Drug

Intervention Name(s)

Mycophenolate mofetil

Intervention Description

Mycophenolate mofetil

Intervention Type

Drug

Intervention Name(s)

Azathioprine

Intervention Description

Azathioprine

Primary Outcome Measure Information:

Title

Time to renal flare

Time Frame

5 years

Secondary Outcome Measure Information:

Title

Number of withdrawals due to toxicity

Time Frame

5 years and 10 years

Title

Cumulated glucocorticoid intake

Time Frame

5 years and 10 years

Title

Number of treatment failures

Time Frame

5 years and 10 years

Title

24-hour proteinuria over time

Time Frame

5 years and 10 years

Title

Serum creatinine titers

Time Frame

5 years and 10 years

Title

Time to renal flare

Time Frame

10 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Frédéric A Houssiau, MD, PhD

Organizational Affiliation

Université Catholique de Louvain

Official's Role

Principal Investigator

Facility Information:

Facility Name

Université catholique de Louvain

City

Bruxelles

ZIP/Postal Code

B-1200

Country

Belgium

12. IPD Sharing Statement

Citations:

PubMed Identifier

26629352

Citation

Tamirou F, Lauwerys BR, Dall'Era M, Mackay M, Rovin B, Cervera R, Houssiau FA; MAINTAIN Nephritis Trial Investigators. A proteinuria cut-off level of 0.7 g/day after 12 months of treatment best predicts long-term renal outcome in lupus nephritis: data from the MAINTAIN Nephritis Trial. Lupus Sci Med. 2015 Nov 12;2(1):e000123. doi: 10.1136/lupus-2015-000123. eCollection 2015.

Results Reference

derived

PubMed Identifier

25757867

Citation

Tamirou F, D'Cruz D, Sangle S, Remy P, Vasconcelos C, Fiehn C, Ayala Guttierez Mdel M, Gilboe IM, Tektonidou M, Blockmans D, Ravelingien I, le Guern V, Depresseux G, Guillevin L, Cervera R, Houssiau FA; MAINTAIN Nephritis Trial Group. Long-term follow-up of the MAINTAIN Nephritis Trial, comparing azathioprine and mycophenolate mofetil as maintenance therapy of lupus nephritis. Ann Rheum Dis. 2016 Mar;75(3):526-31. doi: 10.1136/annrheumdis-2014-206897. Epub 2015 Mar 10.

Results Reference

derived

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Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy of Lupus Nephritis.

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