drugset / Trial / NCT03617536

A Study to Evaluate the Safety and Efficacy of CR845 in Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus

NCT03617536 ↗

Phase 2 Completed 269 enrolled Cara Therapeutics, Inc.
RandomizedParallel-groupDouble-blindTreatment

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).

Timeline

Start
2018-07-05
Primary completion
2019-10-24
Completion
2019-11-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Difelikefalin Protein / enzyme biologic 0.25 mg Oral
Subject Difelikefalin Protein / enzyme biologic 0.5 mg Oral
Subject Difelikefalin Protein / enzyme biologic 1 mg Oral