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 |