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NCT03617536 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Safety and Efficacy of CR845 in Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus
A Phase 2 study, sponsored by Cara Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 269
- Enrollment target
NCT03617536: Completed Phase 2 study, sponsored by Cara Therapeutics.
NCT03617536 is a Phase 2 study that has completed, run by Cara Therapeutics. The registered enrollment target is 269 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (102% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03617536, a Phase 2 study, has completed, sponsored by Cara Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 269 participants
- Enrollment target
Study Summary
This is a multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of 3 dose levels of oral CR845 compared to placebo in reducing the intensity of itch in chronic kidney disease (CKD) patients with moderate-to-severe pruritus. This study will consist of a Screening Period, a 7-day Run-in Period, a 12 week Treatment Period, and a Follow-up Visit (approximately 7 days after the last dose of study drug).
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". Higher scores meant worse itch intensity.
Interventions
- DRUG Placebo Oral Tablet
- DRUG CR845 0.25 mg Oral Tablet
- DRUG CR845 0.5 mg Oral Tablet
- DRUG CR845 1 mg Oral Tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 269 participants |
| Start Date | 2018-07-05 |
| Est. Completion | 2019-11-14 |
| Phase | Phase 2 |
What the finished NCT03617536 record still lists
NCT03617536 is an interventional study that assigns participants to a tested intervention. The registered 269 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (102% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo Oral Tablet is the first listed.
NCT03617536 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03617536 about?
NCT03617536 is a clinical study titled "A Study to Evaluate the Safety and Efficacy of CR845 in 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 3 dose levels of oral CR845 compared to placebo in reducing the intensity of itch in chronic kidney disease (CKD) patients with moderate-to-severe pruritus. This study will consist of a S...
What is the current status of trial NCT03617536?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 269 participants. The study started on 2018-07-05. Estimated completion is 2019-11-14.
What interventions are being tested in trial NCT03617536?
The interventions under investigation include: Placebo Oral Tablet (DRUG), CR845 0.25 mg Oral Tablet (DRUG), CR845 0.5 mg Oral Tablet (DRUG), CR845 1 mg Oral Tablet (DRUG).
Who is sponsoring clinical trial NCT03617536?
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 NCT03617536's enrollment target sits among peer trials
269 208th of 2000 higher than 1,793 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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