Efficacy of Leflunomide, Telmisartan, and Clopidogrel for Immunoglobulin A Nephropathy: A Randomized Controlled Trial

2016
Background: The efficacy and safety of telmisartancombined with clopidogrel, leflunomide, or both drugs for immunoglobulin A nephropathy (IgAN) are unclear. This study was designed to evaluate the efficacy and safety of telmisartancombined with clopidogrel, leflunomide, or both drugs for IgAN. Methods: It is a multicenter, prospective, double-dummy randomized controlled trial. Primary IgAN patients were recruited in 13 renal units across Beijing, China, from July 2010 to June 2012. After a 4-week telmisartan(80 mg/d) wash-in, 400 patients continuing on 80 mg/d telmisartanwere randomly assigned to additionally receive placebo (Group A), 50 mg/d clopidogrel(Group B), 20 mg/d leflunomide(Group C), or 50 mg/d clopidogreland 20 mg/d leflunomide(Group D). The 24-week intervention was completed by 360 patients. The primary endpoint was change in 24-h proteinuriaat 24 weeks. A linear mixed-effect model was used to analyze the changes at 4, 12, and 24 weeks. Generalized estimating equationswere used to evaluate changes in hematuria grade. This trial was registered at the Chinese Clinical Trial Registry. Results: The effects of telmisartancombined with leflunomideon changes in proteinuria(0.36 [95% confidence interval ( CI ) 0.18–0.55] g/d, P CI 57.44–96.49] μmol/L, P CI 6.54–12.44] μmol/L, P I −9.46 to −3.98] ml·min −1 ·1.73 m −2 , P P > 0.05). Telmisartancombined with clopidogrelhad no statistical effect on any outcome, and there was no interaction between the interventions. No obvious adverse reactions were observed. Conclusions: Telmisartancombined with leflunomide, not clopidogrel, is safe and effective for decreasing proteinuriain certain IgAN patients. Trial Registration: chictr.org.cn, ChiCTR-TRC-10000776; http://www.chictr.org.cn/showproj.aspx?proj=8760 .
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