Safety and Pharmacokinetics of IV CR845 in Hemodialysis Patients, and Its Efficacy in Patients With Uremic Pruritus

Phase 2 Completed 89 enrolled Cara Therapeutics, Inc.

RandomizedParallel-groupDouble-blindTreatment

Summary

The primary purpose of this study is to: * Evaluate the safety and pharmacokinetic profile of repeated doses IV CR845 over one week in patients who are undergoing hemodialysis. (Part A) * This study is also investigating whether repeated doses of IV CR845 over two weeks is safe and effective in reducing the intensity of itching in hemodialysis patients with uremic pruritus (Part B).

Timeline

Start: 2014-07
Primary completion: 2015-07
Completion: 2015-07

Publications

Spencer RH, Noonan PK, Marbury T, Menzaghi F. Impact of renal impairment on the pharmacokinetic profile of intravenous difelikefalin, a kappa opioid receptor agonist for the treatment of pruritus. BMC Nephrol. 2024 Oct 14;25(1):351. doi: 10.1186/s12882-024-03790-w.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Difelikefalin	Protein / enzyme biologic	0.5 ug/kg	Intravenous
Subject	Difelikefalin	Protein / enzyme biologic	1 ug/kg	Intravenous
Subject	Difelikefalin	Protein / enzyme biologic	2.5 ug/kg	Intravenous

Indications

No indication recorded.