The purpose of the study is to determine whether mycophenolate mofetil is superior to azathioprine to prevent flares of lupus nephritis.
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
105
Mycophenolate mofetil
Azathioprine
Université catholique de Louvain
Brussels, Belgium
Time to renal flare
Time frame: 5 years
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
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