NCT02229929

Safety and Pharmacokinetics of IV CR845 in Hemodialysis Patients, and Its Efficacy in Patients With Uremic Pruritus

A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Pharmacokinetics of Intravenous CR845 in Hemodialysis Patients, and Its Safety and Efficacy in Hemodialysis Patients With Uremic Pruritus

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: Cara Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to: * Evaluate the safety and pharmacokinetic profile of repeated doses IV CR845 over one week in patients who are undergoing hemodialysis. (Part A) * This study is also investigating whether repeated doses of IV CR845 over two weeks is safe and effective in reducing the intensity of itching in hemodialysis patients with uremic pruritus (Part B).

Detailed description

Placebo-controlled

Conditions

• Pruritus
• Uremic Pruritus

Interventions

Type	Name	Description
DRUG	Part A: Placebo	Part A: Single i.v. dose of Placebo administered after each dialysis session over a 1 week treatment period (3 times per week)
DRUG	Part A: CR845 0.5 mcg/kg	Part A: Single i.v. dose of CR845 administered after each dialysis session over a 1 week treatment period (3 times per week)
DRUG	Part A: CR845 1.0 mcg/kg	Part A: Single i.v. dose of CR845 administered after each dialysis session over a 1 week treatment period (3 times per week)
DRUG	Part A: CR845 2.5 mcg/kg	Part A: Single i.v. dose of CR845 administered after each dialysis session over a 1 week treatment period (3 times per week)
DRUG	Part B: Placebo	Part B: Single i.v. dose of Placebo administered after each dialysis session over a 2 week treatment period (3 times per week)
DRUG	Part B: CR845 1.0 mcg/kg	Part B: Single i.v. dose of CR845 administered after each dialysis session over a 2 week treatment period (3 times per week)

Timeline

• Start date: 2014-07-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2014-09-03
• Last updated: 2016-08-10

Locations

20 sites across 1 country: United States