Leflunomide Versus Azathioprine for Maintenance Therapy of Lupus Nephritis

A Randomized Multicenter Trial Comparing Leflunomide and Azathioprine as Remission-Maintaining Treatment for Proliferative Lupus Glomerulonephritis.

Leflunomide versus Azathioprine for Maintenance Therapy 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 this Trial is to compare leflunomide (LEF) 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 of this trial is that LEF is non-inferior to AZA.

Inclusion Criteria:

• Aged 18 to 65 years
• Biopsy-proven proliferative lupus nephritis
• Disease activity, SLEDAI score ≥ 8 points
• Persistent proteinuria (≥ 1g/24h), with or without microscopic hematuria;
• Signed informed consent

Exclusion Criteria:

• Allergy to the LEF, CTX, AZA
• Recent treatment with high-dose glucocorticoids
• Weight <45kg
• Recent treatment with immunosuppressive drugs
• CNS( Central Nerve System) Lupus patients
• Hepatic failure patients
• Severely abnormal renal function or end-stage renal failure
• More exclusion criteria in the protocol