A Clinical Study of MR13A9 in Hemodialysis Patients With Pruritus.

Phase 2 Completed 247 enrolled Kissei Pharmaceutical Co., Ltd. Maruishi Pharmaceutical · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

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

Timeline

Start: 2019-02-01
Primary completion: 2019-10-22
Completion: 2019-10-22

Outcome

Met primary endpoint

registry 0.5 μg/kg Group vs Placebo Group; p = 0.038; Mean Difference (Final Values) -0.80 (95% CI -1.55 to -0.04); MMRM NCT03802617 ↗

registry 1.0 μg/kg Group vs Placebo Group; p = 0.041; Mean Difference (Final Values) -0.78 (95% CI -1.54 to -0.03); MMRM NCT03802617 ↗

Publications

Narita I, Tsubakihara Y, Uchiyama T, Okamura S, Oya N, Takahashi N, Gejyo F; MR13A9-4 Trial Investigators. Efficacy and Safety of Difelikefalin in Japanese Patients With Moderate to Severe Pruritus Receiving Hemodialysis: A Randomized Clinical Trial. JAMA Netw Open. 2022 May 2;5(5):e2210339. doi: 10.1001/jamanetworkopen.2022.10339.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Difelikefalin	Protein / enzyme biologic	0.25 ug/kg	Intravenous
Subject	Difelikefalin	Protein / enzyme biologic	0.5 ug/kg	Intravenous
Subject	Difelikefalin	Protein / enzyme biologic	1 ug/kg	Intravenous

Indications

No indication recorded.