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CR845-310302: A Study to Evaluate the Safety and Efficacy of Difelikefalin in Advanced Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus

NCT05356403 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2024-05-07

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Difelikefalin 1 mg Oral Tablet

Difelikefalin 1 mg medication taken orally 1 time/day

DRUG

Placebo Oral Tablet

Placebo tablet taken orally 1 time/day

Sponsors & Collaborators

  • Cara Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Cara Therapeutics, PhD · Cara Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-26
Primary Completion
2024-02-26
Completion
2024-02-26
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Brazil
  • Bulgaria
  • Germany
  • Hungary
  • Italy
  • Mexico
  • Poland
  • Romania
  • South Korea
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05356403 on ClinicalTrials.gov