Leflunomide Plus Low-dose Prednisone in Patients with Progressive IgA Nephropathy: A Multicenter, Prospective, Randomized, Open-labelled and Controlled Trial
Background: This trial was designed to assess the efficacy and safety of Leflunomide (LEF) plus low-dose prednisone for the treatment of progressive IgA nephropathy (IgAN). Methods: We did a prospective, randomized, open-labelled, multicenter, controlled trial, comprised of 3-month run-in, 12-month treatment and 12-month follow-up phases. After 3-month run-in phase, patients with biopsy-confirmed IgAN at a risk of progression were randomly allocated to LEF plus low-dose prednisone (LEF group)
... isone (LEF group) or conventionally accepted-dose prednisone (prednisone group). Our primary outcome was 24h urine protein excretion(UPE) and secondary outcomes were serum albumin(sALB), serum creatinine(Scr), and eGFR. Safety was evaluated in all patients who received the trial medications. Results:108 patients (59 in LEF group, 49 in prednisone group) were enrolled and finished their treatment and follow-up periods. The difference in baseline data between the two groups was comparable. Compared with baseline, both groups showed significant decrease in 24h UPE(p<0.01) and increase in sALB (p<0.01), with stable Scr and eGFR throughout the 12-month treatment period. What's more, these effects sustained through the 12-month follow-up period. However, there was no difference in 24h UPE, sALB, Scr and eGFR between the two groups (P>0.05). At 12 months, difference of overall response rate, relapsing rate and incidence of adverse events between the two groups was not significant. Conclusions: The efficacy and safety of LEF plus low-dose prednisone and conventionally accepted-dose prednisone in treatment of progressive IgAN are comparable. Trial registration: The trial is registered at isrctn.org with the ISRCTN97636235 on July 28, 2006.