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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 is a Phase 3 study of Uremic Pruritus that has completed, run by Cara Therapeutics. The registered enrollment target is 378 participants. The trial reports 20 study locations across 4 states.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03422653
The ClinicalTrials.gov registry entry for NCT03422653 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 378 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 1 condition, with Uremic Pruritus appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03422653 reports 20 study locations spanning 4 distinct geographic areas - top geographies include 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.
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