Extension Study to Evaluate IV CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus

Uremic Pruritus Clinical Trial

Official title: An Open-Label, Multicenter, Extension Study to Evaluate the Long Term Safety of Intravenous CR845 in Hemodialysis Patients With Chronic Kidney Disease-Associated Pruritus

Status Completed

Clinical Trial Summary

This is an open-label multicenter, long-term extension safety study to evaluate the safety of IV CR845 administered after each dialysis session over a Treatment Period of up to 52 weeks.

Clinical Trial Description

This is an open-label multicenter, long-term extension safety study to evaluate the safety of IV CR845 administered after each dialysis session over a Treatment Period of up to 52 weeks. This study will consist of a Screening Visit, a 52 week Treatment Period, and a Follow-up Visit. Informed consent will be obtained prior to performing any study-specific procedures. All patients will have a Screening Visit, which can be performed anytime within 14 days prior to the first dose of study drug, to confirm eligibility.

Clinical laboratory tests, electrocardiograms (ECGs), vital signs, adverse events, and concomitant medications will be monitored throughout the study. Blood samples for inflammatory biomarkers will be collected from all patients prior to dialysis on Day 1 and periodically until the End of Treatment or Early Termination Visit. Blood samples will also be collected periodically for clinical laboratory tests. ;

Related Conditions & MeSH terms

• Pruritus
• Uremic Pruritus

• NCT number: NCT03281538
• Study type: Interventional
• Source: Cara Therapeutics, Inc.
• Status: Completed
• Phase: Phase 3
• Start date: August 14, 2017
• Completion date: February 11, 2020