Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy of Lupus Nephritis.
MAINTAIN
A Randomized Multicenter Trial Comparing Mycophenolate Mofetil and Azathioprine as Remission-maintaining Treatment for Proliferative Lupus Glomerulonephritis. The MAINTAIN Nephritis Trial.
1 other identifier
interventional
105
1 country
1
Brief Summary
The purpose of the study is to determine whether mycophenolate mofetil is superior to azathioprine to prevent flares of lupus nephritis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Feb 2001
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2001
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 20, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedOctober 14, 2011
October 1, 2011
10.5 years
September 12, 2005
October 13, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to renal flare
5 years
Secondary Outcomes (6)
Number of withdrawals due to toxicity
5 years and 10 years
Cumulated glucocorticoid intake
5 years and 10 years
Number of treatment failures
5 years and 10 years
24-hour proteinuria over time
5 years and 10 years
Serum creatinine titers
5 years and 10 years
- +1 more secondary outcomes
Study Arms (2)
1
EXPERIMENTALMycophenolate mofetil (target dose 2g/day)
2
ACTIVE COMPARATORAzathioprine (target dose 2mg/kg/day)
Interventions
Eligibility Criteria
You may qualify if:
- SLE aged ≥ 14 years
- Proteinuria ≥ 500 mg/day
- Biopsy-proven proliferative lupus nephritis
You may not qualify if:
- Recent treatment with high-dose glucocorticoids
- Recent treatment with immunosuppressive drugs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Université catholique de Louvain
Brussels, B-1200, Belgium
Related Publications (2)
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.
PMID: 26629352DERIVEDTamirou 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.
PMID: 25757867DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Frédéric A Houssiau, MD, PhD
Université Catholique de Louvain
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professeur Ordinaire, Chef de Service Clinique
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 20, 2005
Study Start
February 1, 2001
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
October 14, 2011
Record last verified: 2011-10