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NCT05356403 · ClinicalTrials.gov registry record · Phase 3
CR845-310302: A Study to Evaluate the Safety and Efficacy of Difelikefalin in Advanced Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus
A Phase 3 study, sponsored by Cara Therapeutics.
- Terminated
- Registry status
- Phase 3
- Development phase
- 105
- Enrollment target
NCT05356403: Clinical Trial Phase 3 study, sponsored by Cara Therapeutics.
NCT05356403 is a Phase 3 study that was terminated before completion, run by Cara Therapeutics. The registered enrollment target is 105 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05356403, a Phase 3 study, was terminated before completion, sponsored by Cara Therapeutics.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 105 participants
- Enrollment target
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.
Primary Outcome
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".
Interventions
- DRUG Placebo Oral Tablet
- DRUG Difelikefalin 1 mg Oral Tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2022-08-26 |
| Est. Completion | 2024-02-26 |
| Phase | Phase 3 |
Why NCT05356403 stopped before completion
NCT05356403 is an interventional study that assigns participants to a tested intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo Oral Tablet is the first listed.
NCT05356403 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05356403 about?
NCT05356403 is a clinical study titled "CR845-310302: A Study to Evaluate the Safety and Efficacy of Difelikefalin in Advanced Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus". 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...
What is the current status of trial NCT05356403?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 105 participants. The study started on 2022-08-26. Estimated completion is 2024-02-26.
What interventions are being tested in trial NCT05356403?
The interventions under investigation include: Placebo Oral Tablet (DRUG), Difelikefalin 1 mg Oral Tablet (DRUG).
Who is sponsoring clinical trial NCT05356403?
This trial is sponsored by Cara Therapeutics, which has 23 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05356403's enrollment target sits among peer trials
105 1670th of 2000 higher than 330 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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