A Clinical Study of MR13A9 in Hemodialysis Patients With Pruritus.

• Status: Completed
• Trial end date: 2019-10-22
• Target enrollment: 0
• Participant gender: All

Summary

Double-blind, Placebo-controlled study to evaluate the dose-response relationship of safety, efficacy and pharmacokinetics of MA13A9 in hemodialysis patients with pruritus.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kissei Pharmaceutical Co., Ltd.
• Collaborator: Maruishi Pharmaceutical

Criteria

Inclusion Criteria:

• Japanese with male or female aged ≥ 20

• Patient with Chronic Kidney Disease (CKD) has been on hemodialysis 3 times per week

• Patient receiving treatment for itch

• Patient has a baseline NRS score > 4

Exclusion Criteria:

• Patient has pruritus cause other than CKD or its complications

• Patients has hepatic cirrhosis

• Patient has a known history of allergic reaction to opiates