Trial · Interventional

TerminatedPhase 3Registry data

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

NCTNCT05342623Other idCR845-310301

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

Reason given at the registry: Corporate decision to discontinue work in advanced chronic kidney disease.

Overview

Status: Terminated
Phase: Phase 3
Enrollment: 286 participants (actual)
Sponsor: Cara Therapeutics, Inc. · Industry
Design: Randomized · Double masking
Countries: 1 country
United States
Start: 17 May 2022
Primary completion: 29 Feb 2024
Completion: 29 Feb 2024
First posted: 22 Apr 2022
Last update posted: 7 May 2024
Conditions: Chronic Kidney Diseases · Pruritus

Timeline

1 trial · 1 stopped early

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2022202320242025

Ph 3
A Study to Evaluate the Safety and Efficacy of Difelikefalin in Advanced Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus
NCT05342623
17 May 2022 to 29 Feb 2024
Terminated
Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This is a multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of oral difelikefalin administered as a 1 mg tablet once daily compared to placebo in reducing the intensity of itch in advanced chronic kidney disease (CKD) patients with moderate-to-severe pruritus. This study is comprised of an Efficacy Assessment Phase and a Long-term Extension Phase. The Efficacy Assessment Phase includes a double-blind 12-week Treatment Period (Treatment Period 1), and the Long-term Extension Phase includes a double-blind Treatment Period (Treatment Period 2) of up to 52 weeks.

Interventions

Difelikefalin 1 mg Oral TabletDrug
Placebo Oral TabletDrug

Arms2

Experimental
Difelikefalin 1 mg Oral Tablet
Patients receive oral difelikefalin 1 mg once daily
Placebo comparator
Placebo Oral Tablet
Patients receive oral placebo once daily

Primary outcomes1

Outcomes the sponsor listed as primary.

Efficacy Assessment Phase (Treatment Period 1): Proportion of subjects achieving at least a 4-point improvement from baseline with respect to the weekly mean of the daily 24-hour WI-NRS score at Week 12 of Treatment Period 1
Time frame · Week 12 of Treatment Period 1
Registry description
Intensity of itch will be measured using an NRS used to indicate the intensity of the worst itching over the past 24 hours using a 0 to 10 numeric rating scale, where "0" represents "no itching" and "10" represents "worst itching imaginable".

Secondary outcomes(4)

Efficacy Assessment Phase (Treatment Period 1): Proportion of subjects achieving at least a 4-point improvement from baseline with respect to the weekly mean of the WI-NRS at Week 8 of Treatment Period 1.
Time frame · Week 8 of Treatment Period 1
Registry description
Intensity of itch will be measured using an NRS used to indicate the intensity of the worst itching over the past 24 hours using a 0 to 10 numeric rating scale, where "0" represents "no itching" and "10" represents "worst itching imaginable".
Efficacy Assessment Phase (Treatment Period 1): Proportion of subjects achieving at least a 4-point improvement from baseline with respect to the weekly mean of the WI-NRS at Week 4 of Treatment Period 1.
Time frame · Week 4 of Treatment Period 1
Registry description
Intensity of itch will be measured using an NRS used to indicate the intensity of the worst itching over the past 24 hours using a 0 to 10 numeric rating scale, where "0" represents "no itching" and "10" represents "worst itching imaginable".
Efficacy Assessment Phase (Treatment Period 1): Proportion of subjects who are "complete itch responders" defined as subjects with ≥ 70% of the non-missing 24-hour WI-NRS scores equal to 0 or 1 at Week 12 of Treatment Period 1.
Time frame · Week 12 of Treatment Period 1
Registry description
Intensity of itch will be measured using an NRS used to indicate the intensity of the worst itching over the past 24 hours using a 0 to 10 numeric rating scale, where "0" represents "no itching" and "10" represents "worst itching imaginable".
Efficacy Assessment Phase (Treatment Period 1): Change from baseline in Sleep Quality Questionnaire score at the end of Week 12 of Treatment Period 1.
Time frame · Week 12 of Treatment Period 1
Registry description
Sleep Quality will be measured using an NRS used to indicate how much itch has interfered with sleep during the past 24 hours using a 0 to 10 numeric rating scale, where "0" represents "did not interfere" and "10" represents "completely interfered".

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

DerivedWulczyn KE, Shafi T. CKD-Associated Pruritus: Updates on Management and Future Directions. Kidney360. 2026 Jul 1;7(7):1658-1661. doi: 10.34067/KID.0000001172. Epub 2026 Feb 13. No abstract available. PMID 41686509
DerivedDidik S, Golosova D, Xu B, Staruschenko A. Opioids and the Kidney: A Compendium. Kidney360. 2023 Dec 1;4(12):1816-1823. doi: 10.34067/KID.0000000000000291. Epub 2023 Nov 6. PMID 37927032

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 85 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: To be eligible for inclusion into the study, a patient must meet the following criteria: * Advanced stage 4 and 5 CKD and end stage renal disease on hemodialysis * Subject self-reports experiencing at least near-daily (eg, most days of a week) pruritus for at least 6 months prior to screening. * Inadequate response to current or prior treatments (including emollients/moisturizers, topical medications, or systemic treatments) for pruritus prior to screening. Prior to randomization on Day 1 of Treatment Period 1: 1. Has recorded at least 4 WI-NRS scores during the 7-day Run-in Period; and 2. Has a mean baseline WI-NRS score ≥ 5, defined as the average of all non-missing scores reported during the 7-day Run-in Period. Exclusion Criteria: A patient will be excluded from the study if any of the following criteria are met: * Scheduled to receive a renal replacement therapy (dialysis or kidney transplant) during the study. * Has a concomitant disease, significant medical condition or physical/laboratory/ECG/vital signs abnormality that, in the opinion of the investigator, puts the subject at undue risk or interferes with interpretation of study results, impedes completion of the study procedures, or compromises the validity of the study measurements. * New or change of treatment received for itch, including antihistamines and corticosteroids (oral, intravenous, or topical), within 14 days prior to the start of run-in.

PepBank is a research reference. Talk to a doctor before you use any peptide.