drugset / Trial / NCT03617536
A Study to Evaluate the Safety and Efficacy of CR845 in Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus
RandomizedParallel-groupDouble-blindTreatment
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).
Timeline
- Start
- 2018-07-05
- Primary completion
- 2019-10-24
- Completion
- 2019-11-14
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Difelikefalin | Protein / enzyme biologic | 0.25 mg | Oral |
| Subject | Difelikefalin | Protein / enzyme biologic | 0.5 mg | Oral |
| Subject | Difelikefalin | Protein / enzyme biologic | 1 mg | Oral |