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NCT03636269 · ClinicalTrials.gov registry record · Phase 3
CR845-CLIN3103: A Global Study to Evaluate the Safety and Efficacy of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus
A Phase 3 study, sponsored by Cara Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 473
- Enrollment target
NCT03636269: Completed Phase 3 study, sponsored by Cara Therapeutics.
NCT03636269 is a Phase 3 study that has completed, run by Cara Therapeutics. The registered enrollment target is 473 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (39% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03636269, a Phase 3 study, has completed, sponsored by Cara Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 473 participants
- Enrollment target
Study Summary
This is a multicenter, international study to evaluate the safety and efficacy of intravenous (IV) CR845 at a dose of 0.5 mcg/kg administered after each dialysis session. The study includes a 12-week randomized, double-blind, placebo-controlled Phase and a 52-week Open-label Extension Phase.
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". LS means estimated percent, odds ratio and P value used a logistic regression model.
Interventions
- DRUG Placebo
- DRUG CR845 0.5 mcg/kg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 473 participants |
| Start Date | 2018-07-17 |
| Est. Completion | 2020-03-30 |
| Phase | Phase 3 |
What the finished NCT03636269 record still lists
NCT03636269 is an interventional study that assigns participants to a tested intervention. The registered 473 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 (39% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03636269 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03636269 about?
NCT03636269 is a clinical study titled "CR845-CLIN3103: A Global Study to Evaluate the Safety and Efficacy of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus". This is a multicenter, international study to evaluate the safety and efficacy of intravenous (IV) CR845 at a dose of 0.5 mcg/kg administered after each dialysis session. The study includes a 12-week randomized, double-blind, placebo-controlled Phase and a 52-week Open-label Extension Phase.
What is the current status of trial NCT03636269?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 473 participants. The study started on 2018-07-17. Estimated completion is 2020-03-30.
What interventions are being tested in trial NCT03636269?
The interventions under investigation include: Placebo (DRUG), CR845 0.5 mcg/kg (DRUG).
Who is sponsoring clinical trial NCT03636269?
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 NCT03636269's enrollment target sits among peer trials
473 811th of 2000 higher than 1,190 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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