Tacrolimus Versus Cyclophosphamide as Treatment for Lupus Nephritis

Summary

In this comparative open-label cohort study, the investigators compared the efficacy and safety of tacrolimus (TAC)and cyclophosphamide (CYC) in the treatment of diffuse proliferative and membranous lupus nephritis with severe renal disease. Treatment of lupus nephritis (LN) with cyclophosphamide is effective, but retain a certain proportion of renal function exacerbations. Tacrolimus may be a suitable substitute treatment for CYC. Methods: Forty patients with diffuse proliferative or membranous were recruited for this trial, 45% of them had lower Ccr (\<60mL/min/1.73m2), 10% had increased serum creatinine (\>180µmol/L) and 67.5% had nephritic proteinuria (\>3.5g/day). The investigators compared the efficacy and adverse effects of TAC (0.04-0.08 mg/kg/d) and prednisone for 12 months (TAC group) with pulse cyclophosphamide (750mg/m2 per month for six months) and prednisone followed by azathioprine (50mg/day）for 6 months (CYC group).

Timeline

Start

2003-03

Primary completion

2010-03

Completion

2010-06

Drugs

Indications