NCT03617536

A Study to Evaluate the Safety and Efficacy of CR845 in Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus

A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety and Efficacy of Oral CR845 in Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 269 (actual)
• Sponsor: Cara Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of 3 dose levels of oral CR845 compared to placebo in reducing the intensity of itch in chronic kidney disease (CKD) patients with moderate-to-severe pruritus. This study will consist of a Screening Period, a 7-day Run-in Period, a 12 week Treatment Period, and a Follow-up Visit (approximately 7 days after the last dose of study drug).

Detailed description

This study will consist of a Screening Period, a 7-day Run-in Period, a 12 week Treatment Period, and a Follow-up Visit (approximately 7 to 10 days after the last dose of study drug). Informed consent will be obtained prior to performing any study-specific procedures. Screening will occur within 7 to 28 days prior to randomization to assess eligibility. If patients continue to meet all inclusion and no exclusion criteria at the end of the 7-day Run-in Period, they will be randomized in a 1:1:1:1 ratio to receive orally once daily either placebo or CR845 tablets at doses of 0.25, 0.5 or 1 mg. Randomization will be stratified according to the patient's renal disease status: moderate CKD; severe CKD non-dialysis; severe CKD on dialysis (ie, 3 categories). A final safety Follow-up Visit will be conducted 7 to 10 days after the last dose of study drug.

Conditions

• Chronic Kidney Diseases
• Pruritus

Interventions

Type	Name	Description
DRUG	CR845 0.25 mg Oral Tablet	CR845 0.25 mg medication taken orally 1 time/day
DRUG	CR845 0.5 mg Oral Tablet	CR845 0.5 mg medication taken orally 1 time/day
DRUG	CR845 1 mg Oral Tablet	CR845 1 mg medication taken orally 1 time/day
DRUG	Placebo Oral Tablet	Placebo tablet taken orally 1 time/day

Timeline

• Start date: 2018-07-05
• Primary completion: 2019-10-24
• Completion: 2019-11-14
• First posted: 2018-08-06
• Last updated: 2024-01-24
• Results posted: 2024-01-24

Locations

60 sites across 1 country: United States

Regulatory

• FDA-regulated drug study