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

Phase 2

Completed

• Conditions: Pruritus; Uremic Pruritus

• Registration Number: NCT02229929
• Lead Sponsor: Cara Therapeutics, Inc.

Brief 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

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-08-27
• Study First Submitted QC: 2014-08-28
• Study First Posted: 2014-09-03
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2016-08
• Disposition First Submitted: 2016-08-08
• Disposition First Submitted QC: 2016-08-08
• Last Update Submitted: 2016-08-08
• Disposition First Posted: 2016-08-10
• Last Update Posted: 2016-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Part B: Change in Worst Itching Intensity using a 100-mm Visual Analog Scale	2 weeks	Change from baseline to the average of Week 2 worst itching (daytime and nighttime) VAS where 0 mm represents "No Itch" and 100 mm represents the "Worst Itch You Can Imagine".
Part A: Determine the Pharmacokinetics of Repeated Doses of CR845 in Hemodialysis Patients (half-life, Cmax, Tmax, AUC, Vd)	1 week	To evaluate the pharmacokinetics of repeated doses of CR845 in hemodialysis patients over a one-week treatment period.

Secondary Outcome Measures

Name	Time	Method
Part B: Sleep disturbance assessed using Itch Medical Outcomes Study (MOS) survey	2 weeks	Change from baseline to Day 15 in itch-related sleep disturbance based on the Itch MOS sleep problems index II (SLP-9)
Part B: Change in quality-of-life assessed using the Skindex-10 survey	2 weeks	Change from baseline to Day 15 in itch-related quality of life as assessed by the total Skindex-10 scores

Trial Locations

Locations (14)

University of Florida College of Medicine Jacksonville; 🇺🇸 Jacksonville, Florida, United States

North American Research Institute; 🇺🇸 San Dimas, California, United States

Valley Renal Medical Group; 🇺🇸 Northridge, California, United States

Winthrop University Hospital; 🇺🇸 Mineola, New York, United States

Nephrology Specialists Medical Group, Inc; 🇺🇸 Orange, California, United States

Pines Clinical Research, Inc.; 🇺🇸 Pembroke Pines, Florida, United States

Western New England Renal & Transplant Associates, PC; 🇺🇸 Springfield, Massachusetts, United States

US Renal Care; 🇺🇸 San Antonio, Texas, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

Orlando Clinical Research Center; 🇺🇸 Orlando, Florida, United States

Trude Weishaupt Memorial Dialysis Center; 🇺🇸 Fresh Meadows, New York, United States

Brookview Hills Research Associates, LLC; 🇺🇸 Winston Salem, North Carolina, United States

Emory Dialysis Center at Northside; 🇺🇸 Atlanta, Georgia, United States

Southeast Renal Research Institute; 🇺🇸 Chattanooga, Tennessee, United States