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Extension Study to Evaluate IV CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus
NCT03281538 · View on ClinicalTrials.gov ↗
Study Summary
This is an open-label multicenter, long-term extension safety study to evaluate the safety of IV CR845 administered after each dialysis session over a Treatment Period of up to 52 weeks.
Conditions Studied
Interventions
- DRUG CR845
Study Locations (20)
California
- Cara Therapeutics Study Site — Chula Vista
- Cara Therapeutics Study Site — El Centro
- Cara Therapeutics Study Site — Long Beach
- Cara Therapeutics Study Site — Northridge
Florida
- Cara Therapeutics Study Site — Hollywood
- Cara Therapeutics Study Site — Tampa
- Cara Therapeutics Study Site — Winter Park
Georgia
- Cara Therapeutics Study Site — Albany
- Cara Therapeutics Study Site — Augusta
New Mexico
- Cara Therapeutics Study Site — Albuquerque
- Cara Therapeutics Study Site — Gallup
New York
- Cara Therapeutics Study Site — Mineola
- Cara Therapeutics Study Site — Ridgewood
Colorado
- Cara Therapeutics Study Site — Denver
Idaho
- Cara Therapeutics Study Site — Meridian
Massachusetts
- Cara Therapeutics Study Site — Springfield
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 288 participants |
| Start Date | 2017-08-14 |
| Est. Completion | 2020-02-11 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03281538
The ClinicalTrials.gov registry entry for NCT03281538 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 288 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 1 intervention — of which CR845 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: NCT03281538 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, Florida, Georgia. 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 NCT03281538 about?
NCT03281538 is a clinical study titled "Extension Study to Evaluate IV CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus". This is an open-label multicenter, long-term extension safety study to evaluate the safety of IV CR845 administered after each dialysis session over a Treatment Period of up to 52 weeks.
What is the current status of trial NCT03281538?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 288 participants. The study started on 2017-08-14. Estimated completion is 2020-02-11.
What conditions does trial NCT03281538 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 NCT03281538?
The interventions under investigation include: CR845 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03281538?
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 NCT03281538 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Georgia, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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