Treatment of IgA nephropathy with leflunomide:a prospective multicenter controlled clinical trial

Objective To evaluate the efficacy and safety of leflunomide(LEF) in the treatment of IgA nephropathy.Methods From April 2004 to October 2005,60 patients with IgA nephropathy in four medical centers in Shenzhen were assigned randomly to two groups:LEF group (n=36),prednisone group (n=24).Patients of LEF group were treated with LEF 20 mg once a day.Patients of prednisone group were treated with prednisone 0.5 mg/kg,reduced 5 mg every 2 weeks after 8 weeks.Blood pressure,24 h urine protein,blood urea nitrogen,blood creatinine,blood routine,liver function,serum albumin,blood uric acid,urine erythrocyte and average arterial pressure were monitored.Efficacy and safety were evaluated at 12 weeks after treatment.Results Complete remission rate was 26.5% in LEF group and 13.0% in prednisone group;total response rate were 50.0% and 65.2%,respectively.The incidence of side-effects were 27.8% and 29.2%.The difference was not statistically significant(P0.05).Prednisone can act more quickly than LEF.After treatment blood pressure decreased significantly in LEF group(P0.05).Conclusion LEF has the same effect as prednisone in the therapy of IgA nephropathy,and it was safe.The long-term efficacy and safety remains to be clarified.