Hemodialysis
Conditions
Keywords
Difelikefalin, CR845, Physical Withdrawal, Hemodialysis, Dialysis, CKD, ESRD (end stage renal disease), Chronic Kidney Disease, Kidney failure, chronic, Kidney dysfunction
Brief 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
DRUGCR845 0.5 mcg/kg
IV CR845 0.5 mcg/kg as a bolus injection
OTHERPlacebo
IV Placebo as a bolus injection
Sponsors
Cara Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Treatment difference between placebo and CR845-treated group for COWS score at Week 4. | Week 4 |
| Treatment difference between placebo and CR845-treated group for COWS score at Week 5. | Week 5 |
| Treatment difference between placebo and CR845-treated group for maximum Subjective Opiate Withdrawal Scale (SOWS) score over Weeks 1-4 | Week 1-4 |
| Treatment difference between placebo and CR845-treated group for SOWS score at Week 4. | Week 4 |
| Treatment difference between placebo and CR845-treated group for SOWS score at Week 5. | Week 5 |
Countries
United States
Outcome results
None listed