Treatment of progressive IgA nephropathy with leflunomide and steroid delays exacerbation of renal function in patients:a prospective controlled clinical trial

Objective To evaluate the efficacy and safety of leflunomide in the treatment of progressive IgA nephropathy by a prospective controlled clinical trial.Methods Patients with biopsy-confirmed IgA nephropathy and moderate renal function insufficiency(endogenous creatinine clearance rate,CCr29~60min/ml) were recruited.Patients of recent onset who hadn’t been treated with any immunosuppressive drug were given either oral leflunomide (Group leflunomide) plus oral prednisone or oral prednisone alone (Group Control).24-hour urinary protein excretion (URE),serum albumin and creatinine,CCr,hemoglobin,side effect of leflunomide were evaluated before the trial and every 3 months after treatment.Results Total 60 patients were enrolled,5 patients withdrew due to adverse events.The UAEs of patients in both groups decreased significantly after 6 months of treatment,but not statistically different between the two groups,while serum albumin remained unchanged throughout the trial in both groups.At 6 months,serum creatinine increased slightly and CCr decreased little in both groups.From the ninth months,Ccr exacerbated sharply in the two groups.And compared with control group,patients of leflunomide group had smaller serum creatinine than those of control group,which was statistically different,and the decreasing speed of Ccr was delayed in leflunomide group.Conclusion Leflunomide combined with steroid treated patients of progressive IgA nephropathy effectively and could markedly delay further exacerbation of renal function compared with steroid alone.Leflunomide was tolerated generally well,and its efficacy in long-term therapy remained to be clarified.