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NCT05533008 · ClinicalTrials.gov registry record · Phase 1
CR845-100303: Study to Assess the Potential of Physical Withdrawal From Intravenous CR845 (Difelikefalin) in Hemodialysis Patients
A Phase 1 study, sponsored by Cara Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
NCT05533008: Completed Phase 1 study, sponsored by Cara Therapeutics.
NCT05533008 is a Phase 1 study that has completed, run by Cara Therapeutics. The registered enrollment target is 35 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05533008, a Phase 1 study, has completed, sponsored by Cara Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
Study Summary
This is a multicenter, randomized, double-blind, placebo-controlled study to assess the potential of physical withdrawal from CR845 upon treatment discontinuation after 3 weeks of IV administration at a dose of 0.5 mcg/kg in hemodialysis patients. The purpose of this study is to determine whether hemodialysis patients who take CR845 develop physical dependence and experience withdrawal symptoms upon cessation, as exemplified by symptoms consistent with opioid withdrawal. The study will consist of a Screening Phase, a 3-week Open-label Phase, a 2-week randomized, placebo-controlled, Double-blind Phase and a Follow-up Visit.
Interventions
- OTHER Placebo
- DRUG CR845 0.5 mcg/kg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2019-12-31 |
| Est. Completion | 2020-06-11 |
| Phase | Phase 1 |
What the finished NCT05533008 record still lists
NCT05533008 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05533008 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05533008 about?
NCT05533008 is a clinical study titled "CR845-100303: Study to Assess the Potential of Physical Withdrawal From Intravenous CR845 (Difelikefalin) in Hemodialysis Patients". This is a multicenter, randomized, double-blind, placebo-controlled study to assess the potential of physical withdrawal from CR845 upon treatment discontinuation after 3 weeks of IV administration at a dose of 0.5 mcg/kg in hemodialysis patients. The purpose of this study is to determine whether he...
What is the current status of trial NCT05533008?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2019-12-31. Estimated completion is 2020-06-11.
What interventions are being tested in trial NCT05533008?
The interventions under investigation include: Placebo (OTHER), CR845 0.5 mcg/kg (DRUG).
Who is sponsoring clinical trial NCT05533008?
This trial is sponsored by Cara Therapeutics, which has 23 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05533008's enrollment target sits among peer trials
35 1258th of 2000 higher than 728 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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