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

Phase 3 Completed 178 enrolled Kissei Pharmaceutical Co., Ltd.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

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.

Timeline

Start: 2021-01-16
Primary completion: 2022-01-25
Completion: 2022-09-26

Outcome

Met primary endpoint

paper The difference between the groups was −0.97 (−1.52 to −0.42), demonstrating that difelikefalin was superior to placebo (P<0.001). PMID 38320524 ↗

Publications

Narita I, Tsubakihara Y, Takahashi N, Ebata T, Uchiyama T, Marumo M, Okamura S, Gejyo F; MR13A9-5 Trial Investigators. Difelikefalin for Hemodialysis Patients with Pruritus in Japan. NEJM Evid. 2023 Nov;2(11):EVIDoa2300094. doi: 10.1056/EVIDoa2300094. Epub 2023 Oct 17.

Drugs

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

Indications

No indication recorded.