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

Kissei

Status and phase: Completed; Phase 3

Conditions: Uremic Pruritus

Treatments: Drug: MR13A9; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04711603

MR13A9-5

Details and patient eligibility

About

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.

Enrollment: 178 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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178 participants in 2 patient groups, including a placebo group

MR13A9/MR13A9

Experimental group

Description:

Patients are administered MR13A9 for 6 weeks (double-blind period), followed by MR13A9 for 52 weeks (open-label period).

Treatment:

Drug: MR13A9

Placebo/MR13A9

Placebo Comparator group

Description:

Patients are administered Placebo for 6 weeks (double-blind period), followed by MR13A9 for 52 weeks (open-label period).

Treatment:

Drug: Placebo

Drug: MR13A9