Demography in Safety and Pharmacokinetics of Lisinopril in Pediatric Kidney Transplant Recipients

Demography data
Study Description
NICHD-2011-HTN01 was a prospective, open-label, multiple center, pharmacokinetics (PK) study of lisinopril in pediatric kidney transplant recipients, aged 2-17 years of age, with stable allograft function and need of medication therapy to control hypertension. The primary objective was to evaluate the safety profile and PK of oral lisinopril. Out of 29 screened participants, 26 received study medication at varying doses and were included in the safety population. Fifteen participants were lisinopril naive and received protocol specific treatment, while eleven received continuing lisinopril as part of standard of care treatment. Twenty-two participants had evaluable PK measurements and were included in the PK analysis population. Overall, lisinopril PK in children with a kidney transplant were comparable to historical groups of children and adults without a kidney transplant. One SAE was reported as unrelated to lisinopril, and one AE led to study drug discontinuation. Otherwise, AE rates were low. Pediatric kidney transplant recipients 2-17 years of age, with stable allograft function and hypertension

人口统计学数据
研究描述
NICHD-2011-HTN01是一项针对年龄2至17岁、移植物功能稳定且需药物治疗控制高血压的儿童肾移植受者的前瞻性、开放标签、多中心赖诺普利（lisinopril）药代动力学（pharmacokinetics, PK）研究。本研究的主要目的为评估口服赖诺普利的安全性概况与药代动力学特征。在29名接受筛查的受试者中，26名接受了不同剂量的研究药物并被纳入安全性人群。其中15名未使用过赖诺普利的受试者接受了方案规定的治疗，11名受试者则作为标准治疗的一部分继续使用赖诺普利。最终有22名可获得有效药代动力学检测数据的受试者被纳入药代动力学分析人群。总体而言，肾移植儿童受试者的赖诺普利药代动力学特征与既往未接受肾移植的儿童及成人队列相似。本研究报告1例严重不良事件（Serious Adverse Event, SAE）与赖诺普利无关，另有1例不良事件（Adverse Event, AE）导致研究药物停用。除此之外，不良事件发生率较低。
本研究的纳入对象为年龄2至17岁、移植物功能稳定且合并高血压的儿童肾移植受者