At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 378 enrolled
Drug / intervention
CR845 0.5 mcg/kg +1 moredrug
Likely dose
CR845 0.5 mcg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety and Efficacy of Intravenous CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus, With a 52-Week Open Label Extension
In Brief
A Phase 3 clinical trial evaluating CR845 0.5 mcg/kg and Placebo for Uremic Pruritus. Completed, enrolled 378 participants across 57 sites.
Detailed Summary
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of intravenous (IV) CR845 at a dose of 0.5 mcg/kg administered after each dialysis session. The study includes a 12-week Double-blind Phase and a 52-week Open-label Extension Phase.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUremic Pruritus
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedFeb 2018
Enrollment StartFeb 2018
Primary CompletionApr 2019
Study CompletionMar 2020
TodayJul 2026
First PostedFeb 6, 2018
Enrollment StartFeb 20, 2018
Primary CompletionApr 6, 2019
Study CompletionMar 26, 2020
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 8.4 years ago
Interventions
CR845 0.5 mcg/kgdrug
IV medication delivered three times/week
Placebodrug
IV medication delivered three times/week