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A Study to Evaluate the Safety and Efficacy of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus (KALM-1)
NCT03422653 · View on ClinicalTrials.gov ↗
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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03422653 reports 20 study locations spanning 4 distinct geographic areas — top geographies include California, Alabama, Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03422653?
The interventions under investigation include: Placebo (DRUG), CR845 0.5 mcg/kg (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03422653?
This trial is sponsored by Cara Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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