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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 is a Phase 3 study that was terminated before completion, run by Cara Therapeutics. The registered enrollment target is 105 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05356403
The ClinicalTrials.gov registry entry for NCT05356403 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 105 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cara Therapeutics, which has 23 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo Oral Tablet is the first listed.
NCT05356403 reports 0 study locations.
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.
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