A Study to Evaluate the Safety and Efficacy of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus (KALM-1)
Public ClinicalTrials.gov record NCT03422653. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety and Efficacy of Intravenous CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus, With a 52-Week Open Label Extension
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03422653
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 378 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 20, 2018 (Actual)
- Primary completion
- Apr 6, 2019 (Actual)
- Completion
- Mar 26, 2020 (Actual)
- Last update posted
- Apr 26, 2022
2018 – 2020
United States locations
- U.S. sites
- 57
- U.S. states
- 20
- U.S. cities
- 55
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cara Therapeutics Study Site | Homewood | Alabama | 35209 | — |
| Cara Therapeutics Study Site | Huntsville | Alabama | 35805 | — |
| Cara Therapeutics Study Site | Bakersfield | California | 93309-5030 | — |
| Cara Therapeutics Study Site 2 | Beverly Hills | California | 90211 | — |
| Cara Therapeutics Study Site | Beverly Hills | California | 90211 | — |
| Cara Therapeutics Study Site | Chula Vista | California | 91910 | — |
| Cara Therapeutics Study Site | Corona | California | 92881 | — |
| Cara Therapeutics Study Site | Escondido | California | 92025 | — |
| Cara Therapeutics Study Site | Fountain Valley | California | 92708 | — |
| Cara Therapeutics | La Mesa | California | 91942 | — |
| Cara Therapeutics Study Site | Long Beach | California | 90807 | — |
| Cara Therapeutics Study Site | Ontario | California | 91762 | — |
| Cara Therapeutics Study Site | Riverside | California | 92505 | — |
| Cara Therapeutics Study Site | Roseville | California | 95661 | — |
| Cara Therapeutics Study Site | San Diego | California | 92111 | — |
| Cara Therapeutics Study Site | San Dimas | California | 91773 | — |
| Cara Therapeutics Study Site | Tarzana | California | 91356 | — |
| Cara Therapeutics Study Site | Denver | Colorado | 80218 | — |
| Cara Therapeutics Study Site | Bridgeport | Connecticut | 06606 | — |
| Cara Therapeutics Study Site | Hartford | Connecticut | 06112 | — |
| Cara Therapeutics Study Site | Middlebury | Connecticut | 06762 | — |
| Cara Therapeutics Study Site 1 | Coral Springs | Florida | 33071 | — |
| Cara Therapeutics Study Site | Hialeah | Florida | 33016 | — |
| Cara Therapeutics Study Site | Miami | Florida | 33125 | — |
| Cara Therapeutics Study Site | Miami Gardens | Florida | 33169 | — |
| Cara Therapeutics Study Site | Tampa | Florida | 33614 | — |
| Cara Therapeutics Study Site | Kalamazoo | Michigan | 49007 | — |
| Cara Therapeutics Study Site | Roseville | Michigan | 48066 | — |
| Cara Therapeutics Study Site | Minneapolis | Minnesota | 55404 | — |
| Cara Therapeutics Study Site | Brookhaven | Mississippi | 39601 | — |
| Cara Therapeutics Study Site | McComb | Mississippi | 39648 | — |
| Cara Therapeutics Study Site | Tupelo | Mississippi | 38801 | — |
| Cara Therapeutics Study Site | Kansas City | Missouri | 64111 | — |
| Cara Therapeutics Study Site | Las Vegas | Nevada | 89102 | — |
| Cara Therapeutics Study Site | Las Vegas | Nevada | 89106 | — |
| Cara Therapeutics Study Site | Eatontown | New Jersey | 07724 | — |
| Cara Therapeutics Study Site | Albuquerque | New Mexico | 87109 | — |
| Cara Therapeutics Study Site | Gallup | New Mexico | 87301 | — |
| Cara Therapeutics Study Site | Fresh Meadows | New York | 11365 | — |
| Cara Therapeutics Study Site | Great Neck | New York | 11021 | — |
| Cara Therapeutics Study Site | The Bronx | New York | 10461 | — |
| Cara Therapeutics Study Site | Durham | North Carolina | 27704 | — |
| Cara Therapeutics Study Site | Canton | Ohio | 44718 | — |
| Cara Therapeutics Study Site | Roseburg | Oregon | 97471 | — |
| Cara Therapeutics Study Site | Chattanooga | Tennessee | 37408 | — |
| Cara Therapeutics Study Site | Dallas | Texas | 75231 | — |
| Cara Therapeutics Study Site | Duncanville | Texas | 75137 | — |
| Cara Therapeutics Study Site | Greenville | Texas | 75402 | — |
| Cara Therapeutics Study Site | Houston | Texas | 77054 | — |
| Cara Therapeutics Study Site | Lewisville | Texas | 75057 | — |
| Cara Therapeutics Study Site | McAllen | Texas | 78503 | — |
| Cara Therapeutics Study Site | Mesquite | Texas | 75150 | — |
| Cara Therapeutics Study Site | San Antonio | Texas | 78207 | — |
| Cara Therapeutics Study Site | Waxahachie | Texas | 75165 | — |
| Cara Therapeutics Study Site | Chesapeake | Virginia | 23320 | — |
| Cara Therapeutics Study Site | Hampton | Virginia | 23666 | — |
| Cara Therapeutics Study Site | Wauwatosa | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03422653, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 26, 2022 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03422653 live on ClinicalTrials.gov.