[Translation] A randomized, double-blind, placebo-controlled, multicenter, phase III study of difelikefalin in Chinese hemodialysis subjects with moderate to severe pruritus
主要目的: 在伴有中度至重度瘙痒的中国 血液透析(HD) 受试者中评估 difelikefalin 0.5 μg/kg 与安慰剂相比在减轻瘙痒强度方面的有效性。
次要目的: 1. 在伴有中度至重度瘙痒的中国 血液透析(HD)受试者中评估 difelikefalin 0.5 μg/kg 与安慰剂相比在改善瘙痒相关生活质量(QoL)方面的有效性。
2. 在伴有中度至重度瘙痒的中国 血液透析(HD) 受试者中评估 difelikefalin 0.5 μg/kg 的安全性。
[Translation] MAIN OBJECTIVE: To evaluate the efficacy of difelikefalin 0.5 μg/kg compared with placebo in reducing pruritus intensity in Chinese hemodialysis (HD) subjects with moderate to severe pruritus.
Secondary objectives: 1. To evaluate the efficacy of difelikefalin 0.5 μg/kg compared with placebo in improving pruritus-related quality of life (QoL) in Chinese hemodialysis (HD) subjects with moderate to severe pruritus.
2. To evaluate the safety of difelikefalin 0.5 μg/kg in Chinese hemodialysis (HD) subjects with moderate to severe pruritus.