NCT03636269

CR845-CLIN3103: A Global Study to Evaluate the Safety and Efficacy of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus

A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety and Efficacy of Intravenous CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus, With a 52-Week Open Label Extension

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 473 (actual)
• Sponsor: Cara Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, international study to evaluate the safety and efficacy of intravenous (IV) CR845 at a dose of 0.5 mcg/kg administered after each dialysis session. The study includes a 12-week randomized, double-blind, placebo-controlled Phase and a 52-week Open-label Extension Phase.

Detailed description

Double-blind Phase: The Double-blind Phase of the study will consist of a Screening Visit, a 7-day Run-in Period, and a 12-week Double-blind Treatment Period. Informed consent will be obtained prior to performing any study-specific procedures. The Screening Visit will occur within 7 to 28 days prior to randomization to assess eligibility. Open-label Extension Phase: Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will have the option to receive open label CR845 for an additional 52 weeks. The last dose of open-label study drug will be administered at the last dialysis visit on Week 52, or Early Termination. Follow-up Period: A final safety Follow up Visit will be conducted 7-10 days after the End of Treatment/Early Termination Visit.

Conditions

• Uremic Pruritus

Interventions

Type	Name	Description
DRUG	CR845 0.5 mcg/kg	IV CR845 0.5 mcg/kg administered three times/week
DRUG	Placebo	IV placebo administered three times/week

Timeline

• Start date: 2018-07-17
• Primary completion: 2020-03-30
• Completion: 2020-03-30
• First posted: 2018-08-17
• Last updated: 2022-04-26
• Results posted: 2022-04-26

Locations

92 sites across 11 countries: United States, Australia, Canada, Czechia, Germany, Hungary, New Zealand, Poland, South Korea, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study