Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy of Lupus Nephritis.

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

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.

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