临床试验/NCT00793156

NCT00793156Unknown3 期

A Randomized-Withdrawal Phase 3 Study Evaluation the Safety and Efficacy of Oral Nalfurafine HCl (AC-820)in Subjects on Hemodialysis With Uremic Pruritus (Renal Itch)

Acologix, Inc.0 个研究点目标入组 350 人开始时间: 2009年12月最近更新: 2010年2月4日

适应症

干预措施

试验速览

阶段: 3 期
发起方: Acologix, Inc.
入组人数: 350
主要终点: Primary efficacy endpoint is the change in worst itching intensity from baseline, compared to that in the last two weeks of the double blind, placebo controlled, randomized withdrawal period.

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

Primary objective of this multicenter, double-blind, placebo controlled, randomized withdrawal study are to determine the effectiveness and safety of orally administered AC-820 in doses of 2.5 µg and 5.0 µg daily in patients with moderate to severe itching associated with end-stage renal disease and hemodialysis, and perform a population PK analysis.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Treatment
盲法: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围: 18 Years 至 80 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•18 yrs old or older
•moderate to severe pruritus
•end stage renal disease
•3x weekly hemodialysis

排除标准

•pruritus not due to renal disease
•abnormal liver function
•Ca-P > 80 mg/dl or HgB <8.5 g/dl or PTH > pg/mL
•Within four months spKt/V < 1.05

研究组 & 干预措施

Placebo

Placebo Comparator

Patients will be randomized into Placebo group

干预措施: Placebo (Other)

2

Active Comparator

2.5 µg group randomized

干预措施: Nalfurafine HCl 2.5 µg (Drug)

3

Active Comparator

5.0 µg group randomized

干预措施: Nalfurafine HCl 5.0 µg (Drug)

结局指标

主要结局

Primary efficacy endpoint is the change in worst itching intensity from baseline, compared to that in the last two weeks of the double blind, placebo controlled, randomized withdrawal period.

时间窗: 11 weeks

次要结局

未报告次要终点

研究者

发起方

Acologix, Inc.

申办方类型

Industry

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