A Phase III Clinical Study of MR13A9 in Hemodialysis Patients With Pruritus.

A Phase III Clinical Study of MR13A9 in Hemodialysis Patients With Pruritus

Double-blind, Placebo-controlled study to confirm the superiority of MR13A9 to placebo, and followed by extension, open-label treatment to confirm long-term safety of MA13A9 in hemodialysis patients with pruritus.

Inclusion Criteria:

• 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