Hemodialysis Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Potential of Physical Withdrawal From Intravenous CR845 (Difelikefalin) in Hemodialysis Patients
Verified date | September 2022 |
Source | Cara Therapeutics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 35 |
Est. completion date | June 11, 2020 |
Est. primary completion date | June 11, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Key Inclusion Criteria: - Has ESRD and has been on hemodialysis 3 times per week for at least 3 months; - Not currently taking opioid medication; - If female, is not pregnant or nursing during any period of the study. Key Exclusion Criteria: • Has a concomitant disease or a history of any condition that, in the opinion of the Investigator, could pose undue risk to the patient, impede completion of the study procedures, or would compromise the validity of the study measurements; Past or present diseases, which as judged by the Investigator, may affect the outcome of this study. |
Country | Name | City | State |
---|---|---|---|
United States | Cara Therapeutics Study Site | Bridgeport | Connecticut |
United States | Cara Therapeutics Study Site | Hartford | Connecticut |
United States | Cara Therapeutics Study Site | Kansas City | Kansas |
United States | Cara Therapeutics Study Site | Minneapolis | Minnesota |
United States | Cara Therapeutics Study Site | Roseville | Michigan |
Lead Sponsor | Collaborator |
---|---|
Cara Therapeutics, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Treatment difference between placebo and CR845-treated group with respect to the maximum Clinical Opiate Withdrawal Scale (COWS) score over Weeks 1-4 | Week 1-4 | ||
Secondary | Treatment difference between placebo and CR845-treated group for COWS score at Week 4. | Week 4 | ||
Secondary | Treatment difference between placebo and CR845-treated group for COWS score at Week 5. | Week 5 | ||
Secondary | Treatment difference between placebo and CR845-treated group for maximum Subjective Opiate Withdrawal Scale (SOWS) score over Weeks 1-4 | Week 1-4 | ||
Secondary | Treatment difference between placebo and CR845-treated group for SOWS score at Week 4. | Week 4 | ||
Secondary | Treatment difference between placebo and CR845-treated group for SOWS score at Week 5. | Week 5 |
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