At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 222 enrolled
Drug / intervention
CR845 0.5 mcg/kgdrug
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.
An Open-Label, Multicenter Study to Evaluate the Safety and Effectiveness of Intravenous CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus
In Brief
A Phase 3 clinical trial evaluating CR845 0.5 mcg/kg for Uremic Pruritus. Completed, enrolled 222 participants across 47 sites in 4 countries.
Detailed Summary
This is a multicenter, open-label study to evaluate the safety and effectiveness of intravenous (IV) CR845 at a dose of 0.5 mcg/kg administered after each dialysis session. The study includes an up to 12-week Treatment Period.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUremic Pruritus
CountriesCzechia, Hungary, Poland, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
Enrollment StartMay 2019
First PostedJun 2019
Primary CompletionFeb 2020
Study CompletionMar 2020
TodayJul 2026
First PostedJun 26, 2019
Enrollment StartMay 6, 2019
Primary CompletionFeb 26, 2020
Study CompletionMar 6, 2020
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 7.0 years ago
Interventions
CR845 0.5 mcg/kgdrug
IV CR845 0.5 mcg/kg administered three times/week