CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 269 enrolled
Drug / intervention
CR845 0.25 mg Oral Tablet +3 moredrug
Likely dose
CR845 0.25 mg Oral Tabletfrom 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.

Search/NCT03617536
NCT03617536Phase 2Completed
CompareCT.gov

A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety and Efficacy of Oral CR845 in Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus

Cara Therapeutics, Inc.·interventional·Posted Aug 6, 2018·Updated Jan 24, 2024

In Brief

A Phase 2 clinical trial evaluating CR845 0.25 mg Oral Tablet, CR845 0.5 mg Oral Tablet, and 2 other interventions for Chronic Kidney Diseases and Pruritus. Completed, enrolled 269 participants across 60 sites.

Detailed Summary

This is a multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of 3 dose levels of oral CR845 compared to placebo in reducing the intensity of itch in chronic kidney disease (CKD) patients with moderate-to-severe pruritus. This study will consist of a Screening Period, a 7-day Run-in Period, a 12 week Treatment Period, and a Follow-up Visit (approximately 7 days after the last dose of study drug).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Kidney Diseases, Pruritus
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedAug 6, 2018
Enrollment StartJul 5, 2018
Primary CompletionOct 24, 2019
Study CompletionNov 14, 2019
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 7.9 years ago

Interventions

CR845 0.25 mg Oral Tabletdrug

CR845 0.25 mg medication taken orally 1 time/day

CR845 0.5 mg Oral Tabletdrug

CR845 0.5 mg medication taken orally 1 time/day

CR845 1 mg Oral Tabletdrug

CR845 1 mg medication taken orally 1 time/day

Placebo Oral Tabletdrug

Placebo tablet taken orally 1 time/day