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NCT02858726 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate IV CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus
A Phase 2 study, sponsored by Cara Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 226
- Enrollment target
NCT02858726: Completed Phase 2 study, sponsored by Cara Therapeutics.
NCT02858726 is a Phase 2 study that has completed, run by Cara Therapeutics. The registered enrollment target is 226 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02858726, a Phase 2 study, has completed, sponsored by Cara Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 226 participants
- Enrollment target
Study Summary
2 Part Study: Part A will assess 3 different dosing levels of IV CR845 versus placebo in patient on hemodialysis who have moderate-to-severe itching due to uremic pruritus. Patients will receive either CR845 or placebo after each dialysis session for eight weeks. The safety and efficacy of CR845 will be monitored throughout the study. A sub-group of patients will also have pharmacokinetic assessments completed. Part B of the study will assess one dose of IVCR845 versus placebo for 12 weeks in patients on hemodialysis who have moderate-to-severe itching. The dose of CR845 used in Part B will be based on safety and efficacy found in Part A.
Primary Outcome
Intensity of itch was measured using a numerical rating scale (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
- DRUG CR845 0.5 mcg/kg
- DRUG CR845 1 mcg/kg
- DRUG CR845 1.5mcg/kg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 226 participants |
| Start Date | 2016-06 |
| Est. Completion | 2017-03-14 |
| Phase | Phase 2 |
What the finished NCT02858726 record still lists
NCT02858726 is an interventional study that assigns participants to a tested intervention. The registered 226 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 (70% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT02858726 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02858726 about?
NCT02858726 is a clinical study titled "Study to Evaluate IV CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus". 2 Part Study: Part A will assess 3 different dosing levels of IV CR845 versus placebo in patient on hemodialysis who have moderate-to-severe itching due to uremic pruritus. Patients will receive either CR845 or placebo after each dialysis session for eight weeks. The safety and efficacy of CR845 wil...
What is the current status of trial NCT02858726?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 226 participants. The study started on 2016-06. Estimated completion is 2017-03-14.
What interventions are being tested in trial NCT02858726?
The interventions under investigation include: Placebo (DRUG), CR845 0.5 mcg/kg (DRUG), CR845 1 mcg/kg (DRUG), CR845 1.5mcg/kg (DRUG).
Who is sponsoring clinical trial NCT02858726?
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 NCT02858726's enrollment target sits among peer trials
226 267th of 2000 higher than 1,734 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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