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NCT03422653 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Safety and Efficacy of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus (KALM-1)
A Phase 3 study of Uremic Pruritus, sponsored by Cara Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 378
- Enrollment target
- 20
- Study locations
NCT03422653: Completed Phase 3 study of Uremic Pruritus, sponsored by Cara Therapeutics.
NCT03422653 is a Phase 3 study of Uremic Pruritus that has completed, run by Cara Therapeutics. The registered enrollment target is 378 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (51% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03422653, a Phase 3 study of Uremic Pruritus, has completed, sponsored by Cara Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 378 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a multicenter, randomized, double-blind, placebo-controlled 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 Double-blind 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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG CR845 0.5 mcg/kg
Study Locations (20)
California
- Cara Therapeutics Study Site - Bakersfield
- Cara Therapeutics Study Site 2 - Beverly Hills
- Cara Therapeutics Study Site - Beverly Hills
- Cara Therapeutics Study Site - Chula Vista
- Cara Therapeutics Study Site - Corona
- Cara Therapeutics Study Site - Escondido
- Cara Therapeutics Study Site - Fountain Valley
- Cara Therapeutics - La Mesa
- Cara Therapeutics Study Site - Long Beach
- Cara Therapeutics Study Site - Ontario
- Cara Therapeutics Study Site - Riverside
- Cara Therapeutics Study Site - Roseville
- Cara Therapeutics Study Site - San Diego
- Cara Therapeutics Study Site - San Dimas
- Cara Therapeutics Study Site - Tarzana
Alabama
- Cara Therapeutics Study Site - Homewood
- Cara Therapeutics Study Site - Huntsville
Connecticut
- Cara Therapeutics Study Site - Bridgeport
- Cara Therapeutics Study Site - Hartford
Colorado
- Cara Therapeutics Study Site - Denver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 378 participants |
| Start Date | 2018-02-20 |
| Est. Completion | 2020-03-26 |
| Phase | Phase 3 |
What the finished NCT03422653 record still lists
NCT03422653 is an interventional study that assigns participants to a tested intervention. The registered 378 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 (51% lower).
The record links to 1 condition, with Uremic Pruritus appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03422653 names 20 study sites across 4 states, led by California, Alabama, Connecticut.
Frequently Asked Questions
What is clinical trial NCT03422653 about?
NCT03422653 is a clinical study titled "A Study to Evaluate the Safety and Efficacy of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus (KALM-1)". This is a multicenter, randomized, double-blind, placebo-controlled 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 Double-blind Phase and a 52-week Open-label Extension Phase.
What is the current status of trial NCT03422653?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 378 participants. The study started on 2018-02-20. Estimated completion is 2020-03-26.
What conditions does trial NCT03422653 study?
This clinical trial studies the following conditions: Uremic Pruritus.
What interventions are being tested in trial NCT03422653?
The interventions under investigation include: Placebo (DRUG), CR845 0.5 mcg/kg (DRUG).
Who is sponsoring clinical trial NCT03422653?
This trial is sponsored by Cara Therapeutics, which has 23 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03422653 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Uremic Pruritus
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03422653's enrollment target sits among peer trials
378 988th of 2000 higher than 1,013 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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