A Clinical Study of MR13A9 in Hemodialysis Patients With Pruritus.

• MR13A9 (Drug): Intravenous administration
• Placebo (Drug): Intravenous administration

Primary outcomes

• Change From Baseline in the Mean NRS Score at Week 8 of the Treatment Period [8 weeks]: The primary analysis was performed using an MMRM with change from baseline in the mean NRS score at each time point as an objective variable; treatment group, time point, and treatment group-by-time point interaction as fixed effects; baseline mean NRS score and dynamic allocation factors, presence of prior treatment with nalfurafine hydrochloride, and presence of specific signs or symptoms to be confirmed in the screening period, as covariates; and subject as a random effect. Looking back on the period between the time of awakening on the previous day of assessment and the time of awakening on the day of assessment (including sleeping hours) once daily, subjects will assess the NRS score for the most severe itching by themselves. The most severe itching within the day will be assessed in integer on a scale ranging from 0 to 10, where 0 represents no itching and 10 represents worst itching imaginable.

Sex: All, ages: 20 Years to any

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

Participant flow

Outcome results

• Change From Baseline in the Mean NRS Score at Week 8 of the Treatment Period (Primary), Mean, points: 0.25 μg/kg Group -2.97 +/- 0.29; 0.5 μg/kg Group -3.65 +/- 0.30; 1.0 μg/kg Group -3.64 +/- 0.30; Placebo Group -2.86 +/- 0.29 (p 0.770)

Adverse events

Time frame: Up to 8 weeks

Serious adverse events by term

Other adverse events by term

• Results publication: 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. PMID 35511180

• Study Protocol (PDF, 2018-11-29)
• Statistical Analysis Plan (PDF, 2020-01-20)

• Naomi Koshihara, Study director, Clinical Development Div.