A Clinical Study of MR13A9 in Hemodialysis Patients With Pruritus.

Kissei

Status and phase: Completed; Phase 2

Conditions: Uremic Pruritus

Treatments: Drug: MR13A9; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03802617

MR13A9-4

Details and patient eligibility

About

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

Enrollment: 247 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

247 participants in 4 patient groups, including a placebo group

MR13A9 low dose

Experimental group

Treatment:

Drug: MR13A9

MR13A9 medium dose

Experimental group

Treatment:

Drug: MR13A9

MR13A9 high dose

Experimental group

Treatment:

Drug: MR13A9

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo