NCT05533008

CR845-100303: Study to Assess the Potential of Physical Withdrawal From Intravenous CR845 (Difelikefalin) in Hemodialysis Patients

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Potential of Physical Withdrawal From Intravenous CR845 (Difelikefalin) in Hemodialysis Patients

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Cara Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hemodialysis

Interventions

Type	Name	Description
DRUG	CR845 0.5 mcg/kg	IV CR845 0.5 mcg/kg as a bolus injection
OTHER	Placebo	IV Placebo as a bolus injection

Timeline

• Start date: 2019-12-31
• Primary completion: 2020-06-11
• Completion: 2020-06-11
• First posted: 2022-09-08
• Last updated: 2022-09-08

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study