CR845 0.5 mcg/kg

DRUG5 trials

Sponsors

Cara Therapeutics, Inc.

Conditions

HemodialysisUremic Pruritus

Phase 1

CR845-100303: Study to Assess the Potential of Physical Withdrawal From Intravenous CR845 (Difelikefalin) in Hemodialysis Patients

CompletedNCT05533008

Cara Therapeutics, Inc.Hemodialysis

Start: 2019-12-31End: 2020-06-11Updated: 2022-09-08

Phase 2

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

CompletedNCT02858726

Cara Therapeutics, Inc.Uremic Pruritus

Start: 2016-06-30End: 2017-03-14Updated: 2020-07-29

Phase 3

A Study to Evaluate the Safety and Efficacy of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus (KALM-1)

CompletedNCT03422653

Cara Therapeutics, Inc.Uremic Pruritus

Start: 2018-02-20End: 2020-03-26Updated: 2022-04-26

CR845-CLIN3103: A Global Study to Evaluate the Safety and Efficacy of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus

CompletedNCT03636269

Cara Therapeutics, Inc.Uremic Pruritus

Start: 2018-07-17End: 2020-03-30Updated: 2022-04-26

CR845-CLIN3105: A Study to Evaluate the Safety and Effectiveness of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus

CompletedNCT03998163

Cara Therapeutics, Inc.Uremic Pruritus

Start: 2019-05-06End: 2020-03-06Updated: 2021-10-15

Related Papers

Influence of Baseline Itch Severity on Treatment Outcomes With Difelikefalin in Adults With Moderate‐to‐Severe Pruritus Receiving Maintenance Haemodialysis: An Exploratory Analysis

Journal of Renal Care2025-05-06

Chronic kidney disease–associated pruritus and quality of life with difelikefalin treatment: a <i>post hoc</i> analysis of phase 3 data using the Skindex-10 questionnaire

Clinical Kidney Journal2024-09-064 citations

Difelikefalin improves itch-related sleep disruption in patients undergoing haemodialysis.

2024-06-019 citations

Impact of Difelikefalin on the Health-Related Quality of Life of Haemodialysis Patients with Moderate-To-Severe Chronic Kidney Disease-Associated Pruritus: A Single-Arm Intervention Trial

Patient2024-01-0912 citations

Safety and Effectiveness of Difelikefalin in Patients With Moderate-to-Severe Pruritus Undergoing Hemodialysis: An Open-Label, Multicenter Study.

2022-08-2414 citations

Efficacy of Difelikefalin for the Treatment of Moderate to Severe Pruritus in Hemodialysis Patients: Pooled Analysis of KALM-1 and KALM-2 Phase 3 Studies

Kidney Medicine2022-06-28103 citations

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 Medicine2022-06-2847 citations

Clinically meaningful change in itch intensity scores: An evaluation in patients with chronic kidney disease–associated pruritus

Journal of the American Academy of Dermatology2020-06-2728 citations

A Phase 3 Trial of Difelikefalin in Hemodialysis Patients with Pruritus

New England Journal of Medicine2019-11-08346 citations