Tacrolimus Versus Cyclophosphamide as Treatment for Lupus Nephritis
Status:
Completed
Trial end date:
2010-06-01
Target enrollment:
Participant gender:
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).