A Study to Evaluate the Safety and Efficacy of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus (KALM-1)
Completed · Phase 3 · Has a placebo group
Conditions studied: Uremic Pruritus
In brief
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.
Key facts
- Study ID
- NCT03422653
- Run by
- Cara Therapeutics, Inc.
- People needed
- 378
- Starts
- 2018-02-20
- Expected to finish
- 2020-03-26
- Last updated by the study team
- 2022-04-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Cara Therapeutics Study Site — Huntsville, Alabama, United States
- Cara Therapeutics Study Site — Bakersfield, California, United States
- Cara Therapeutics Study Site 2 — Beverly Hills, California, United States
- Cara Therapeutics Study Site — Beverly Hills, California, United States
- Cara Therapeutics Study Site — Chula Vista, California, United States
- Cara Therapeutics Study Site — Corona, California, United States
- Cara Therapeutics Study Site — Escondido, California, United States
- Cara Therapeutics Study Site — Fountain Valley, California, United States
- Cara Therapeutics — La Mesa, California, United States
- Cara Therapeutics Study Site — Long Beach, California, United States
- Cara Therapeutics Study Site — Ontario, California, United States
- Cara Therapeutics Study Site — Riverside, California, United States
- Cara Therapeutics Study Site — Roseville, California, United States
- Cara Therapeutics Study Site — San Diego, California, United States
- Cara Therapeutics Study Site — San Dimas, California, United States
- Cara Therapeutics Study Site — Tarzana, California, United States
- Cara Therapeutics Study Site — Denver, Colorado, United States
- Cara Therapeutics Study Site — Bridgeport, Connecticut, United States
- Cara Therapeutics Study Site — Hartford, Connecticut, United States
- Cara Therapeutics Study Site — Middlebury, Connecticut, United States
- Cara Therapeutics Study Site 1 — Coral Springs, Florida, United States
- Cara Therapeutics Study Site — Hialeah, Florida, United States
- Cara Therapeutics Study Site — Miami, Florida, United States
- Cara Therapeutics Study Site — Miami Gardens, Florida, United States
- Cara Therapeutics Study Site — Homewood, Alabama, United States
Full record on ClinicalTrials.gov
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