Clinical trial NCT00204022: Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy of Lupus Nephritis.
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lupus Nephritis
Keywords: Lupus nephritis
Treatment
Maintenance therapy
Mycophenolate mofetil
Azathioprine
Lead sponsor: Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 105
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to renal flare
timeFrame: 5 years
Secondary outcomes:
measure: Number of withdrawals due to toxicity
timeFrame: 5 years and 10 years
measure: Cumulated glucocorticoid intake
timeFrame: 5 years and 10 years
measure: Number of treatment failures
timeFrame: 5 years and 10 years
measure: 24-hour proteinuria over time
timeFrame: 5 years and 10 years
measure: Serum creatinine titers
timeFrame: 5 years and 10 years
measure: Time to renal flare
timeFrame: 10 years
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Université catholique de Louvain
Study officials:
affiliation: Université Catholique de Louvain
name: Frédéric A Houssiau, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.