Extension Study to Evaluate IV CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus

Phase 3 Completed 288 enrolled Cara Therapeutics, Inc.

NaSingle-groupOpen-labelTreatment

Summary

This is an open-label multicenter, long-term extension safety study to evaluate the safety of IV CR845 administered after each dialysis session over a Treatment Period of up to 52 weeks.

Timeline

Start: 2017-08-14
Primary completion: 2020-02-11
Completion: 2020-02-11

Publications

Fishbane S, Wen W, Munera C, Lin R, Bagal S, McCafferty K, Menzaghi F, Goncalves J. Safety and Tolerability of Difelikefalin for the Treatment of Moderate to Severe Pruritus in Hemodialysis Patients: Pooled Analysis From the Phase 3 Clinical Trial Program. Kidney Med. 2022 Jun 28;4(8):100513. doi: 10.1016/j.xkme.2022.100513. eCollection 2022 Aug.

Drugs

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

Indications

No indication recorded.