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. 2016 Nov 16;2016(11):CD008320. doi: 10.1002/14651858.CD008320.pub3

NCT02229929.

Trial name or title A double‐blind, randomized, placebo‐controlled study to evaluate the safety and pharmacokinetics of intravenous CR845 in hemodialysis patients, and its safety and efficacy in hemodialysis patients with uremic pruritus
Methods Multicentre, randomised, double‐blind, placebo‐controlled, parallel assignment, phase 2
Participants 84 haemodialysis patients
Interventions Group 1: CR845 (0.5 mcg/kg, 1.0 mcg/kg, 2.5 mcg/kg)
Group 2: placebo
Outcomes Pharmacokinetics of Repeated Doses of CR845 in Haemodialysis Patients (half‐life, Cmax, Tmax, AUC, Vd); change in worst itching intensity using a 100 mm VAS; change in quality‐of‐life assessed using the Skindex‐10 survey; sleep disturbance assessed using itch Medical Outcomes Study (MOS) survey
Starting date July 2014
Contact information Stephen Cincotta (scincotta@clinicalresearchmgt.com)
Notes Completed