At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 473 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 473 participants across 92 sites in 11 countries.
Detailed Summary
This is a multicenter, international 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 randomized, double-blind, placebo-controlled Phase and a 52-week Open-label Extension Phase.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUremic Pruritus
CountriesAustralia, Canada, Czechia, Germany, Hungary, New Zealand, Poland, South Korea, Taiwan, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
Enrollment StartJul 2018
First PostedAug 2018
Primary CompletionMar 2020
TodayJul 2026
First PostedAug 17, 2018
Enrollment StartJul 17, 2018
Primary CompletionMar 30, 2020
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 7.9 years ago
Interventions
CR845 0.5 mcg/kgdrug
IV CR845 0.5 mcg/kg administered three times/week
Placebodrug
IV placebo administered three times/week