Efficacy and safety of losartan in childhood immunoglobulin A nephropathy: a prospective multicenter study

H. Hyun, Y. Ahn, Eujin Park, Hyun Jin Choi, K. Han, Jung Won Lee, Su Young Kim, Eun Mi Yang, Jin Soon Suh, Jae Il Shin, Min Hyun Cho, Ja Wook Koo, Kee Hyuck Kim, Hye Won Park, I. Ha, H. Cheong, Hee Gyung Kang, Seong Heon Kim
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Abstract

Purpose: Angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers (ARBs) are frequently employed to counteract the detrimental effects of proteinuria on glomerular diseases. However, the effects of ARBs remain poorly examined in pediatric patients with immunoglobulin A (IgA) nephropathy. Herein, we evaluated the efficacy and safety of losartan, an ARB, in pediatric IgA nephropathy with proteinuria. Methods: This prospective, single-arm, multicenter study included children with IgA nephropathy exhibiting proteinuria. Changes in proteinuria, blood pressure, and kidney function were prospectively evaluated before and 4 and 24 weeks after losartan administration. The primary endpoint was the difference in proteinuria between baseline and 24 weeks. Results: In total, 29 patients were enrolled and received losartan treatment. The full analysis set included 28 patients who received losartan at least once and had pre-and post-urinary protein to creatinine ratio measurements (n=28). The per-protocol analysis group included 22 patients who completed all scheduled visits without any serious violations during the study period. In both groups, the mean log (urine protein to creatinine ratio) value decreased significantly at 6 months. After 24 weeks, the uri - nary protein to creatinine ratio decreased by more than 50% in approximately 40% of the patients. The glomerular filtration rate was not significantly altered during the observation period. Conclusions: Losartan decreased proteinuria without decreasing kidney function in patients with IgA nephropathy over 24 weeks. Losartan could be safely employed to reduce proteinuria in this patient population. ClinicalTrials.gov trial registration (NCT0223277)
洛沙坦治疗儿童免疫球蛋白 A 肾病的有效性和安全性:一项前瞻性多中心研究
目的:血管紧张素转换酶抑制剂和血管紧张素受体阻滞剂(ARBs)经常被用来抵消蛋白尿对肾小球疾病的有害影响。然而,在患有免疫球蛋白A (IgA)肾病的儿童患者中,arb的作用仍未得到充分的研究。在此,我们评估了氯沙坦(一种ARB)治疗儿童IgA肾病伴蛋白尿的有效性和安全性。方法:这项前瞻性、单臂、多中心研究纳入了表现为蛋白尿的IgA肾病患儿。前瞻性评估氯沙坦给药前、给药后4周和24周患者蛋白尿、血压和肾功能的变化。主要终点是基线和24周之间蛋白尿的差异。结果:29例患者接受氯沙坦治疗。完整的分析集包括28例至少接受一次氯沙坦治疗的患者,并进行了尿蛋白与肌酐比值的前后测量(n=28)。按方案分析组包括22名患者,他们在研究期间完成了所有预定的就诊,没有任何严重的违规行为。在两组中,平均对数(尿蛋白与肌酐比值)值在6个月时显著下降。24周后,大约40%的患者uri - protein / creatinine ratio下降了50%以上。观察期间肾小球滤过率无明显变化。结论:氯沙坦在IgA肾病患者24周内可降低蛋白尿,但不降低肾功能。氯沙坦可以安全地用于减少这类患者的蛋白尿。ClinicalTrials.gov试验注册(NCT0223277)
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