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CompletedNCT03802617Updated Dec 5, 2025Results posted

A Clinical Study of MR13A9 in Hemodialysis Patients With Pruritus.

A Phase 2 interventional study of MR13A9 and Placebo in Uremic Pruritus, sponsored by Kissei Pharmaceutical Co., Ltd.. Completed at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2025-12-05.

Sponsored by Kissei Pharmaceutical Co., Ltd. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
247
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Uremic Pruritus
03

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
247 participants (actual)

Study arms

  • Experimental
    MR13A9 low dose

    Drug: MR13A9

  • Experimental
    MR13A9 medium dose

    Drug: MR13A9

  • Experimental
    MR13A9 high dose

    Drug: MR13A9

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugMR13A9

    Intravenous administration

  • DrugPlacebo

    Intravenous administration

05

What researchers measure

Primary outcomes

  1. Change From Baseline in the Mean NRS Score at Week 8 of the Treatment Period

    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.

    Time frame: 8 weeks

06

Results

Posted Dec 5, 2025

Participant flow

Of 311 participants who had been screened, 247 subjects were enrolled in this study and were randomly assigned to each study drugs. 225 subjects completed the study and 22 subjects discontinued the study.

Participant flow — Overall Study
Milestone0.25 μg/kg Group0.5 μg/kg Group1.0 μg/kg GroupPlacebo Group
Started61616263
Completed59535459
Not completed2884
Withdrew: Adverse event0451
Withdrew: Lack of efficacy0102
Withdrew: Protocol violation1110
Withdrew: Withdrawal by subject1110
Withdrew: Four consecutive missed doses of the study drug0111

Outcome measures

PrimaryChange From Baseline in the Mean NRS Score at Week 8 of the Treatment Period

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.

Time frame:
8 weeks
Reported as:
Mean · points
Change From Baseline in the Mean NRS Score at Week 8 of the Treatment Period
points0.25 μg/kg Group0.5 μg/kg Group1.0 μg/kg GroupPlacebo Group
Change From Baseline in the Mean NRS Score at Week 8 of the Treatment Period-2.97 ± 0.29-3.65 ± 0.30-3.64 ± 0.30-2.86 ± 0.29
Statistical analysis
  • 0.25 μg/kg Group vs Placebo Group · MMRM · p = 0.770 · Mean difference (net): -0.11 · 95% CI -0.85 to 0.63
  • 0.5 μg/kg Group vs Placebo Group · MMRM · p = 0.038 · Mean difference (final values): -0.80 · 95% CI -1.55 to -0.04
  • 1.0 μg/kg Group vs Placebo Group · MMRM · p = 0.041 · Mean difference (final values): -0.78 · 95% CI -1.54 to -0.03

Adverse events

Collected over Up to 8 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
0.25 μg/kg Group0/61 (0%)3/61 (4.9%)30/61 (49.2%)
0.5 μg/kg Group0/61 (0%)8/61 (13.1%)35/61 (57.4%)
1.0 μg/kg Group0/62 (0%)5/62 (8.1%)40/62 (64.5%)
Placebo Group0/63 (0%)2/63 (3.2%)24/63 (38.1%)
Most frequent serious events
Showing 10 of 21
Most frequent serious events
Event0.25 μg/kg Group0.5 μg/kg Group1.0 μg/kg GroupPlacebo Group
Angina pectorisCardiac disorders0/611/610/620/63
Aortic valve stenosisCardiac disorders1/610/610/620/63
BacteraemiaInfections and infestations0/611/610/620/63
Device related infectionInfections and infestations0/611/610/620/63
GastroenteritisInfections and infestations1/610/610/620/63
Heat illnessInjury, poisoning and procedural complications0/611/610/620/63
Shunt occlusionInjury, poisoning and procedural complications1/610/610/620/63
Shunt stenosisInjury, poisoning and procedural complications0/611/611/620/63
HyperglycaemiaMetabolism and nutrition disorders0/611/610/620/63
Altered state of consciousnessNervous system disorders0/611/610/620/63
Most frequent other events
Showing 10 of 11
Most frequent other events
Event0.25 μg/kg Group0.5 μg/kg Group1.0 μg/kg GroupPlacebo Group
NasopharyngitisInfections and infestations8/616/613/627/63
ConstipationGastrointestinal disorders5/613/617/620/63
SomnolenceNervous system disorders2/613/616/623/63
ArthralgiaMusculoskeletal and connective tissue disorders3/615/612/622/63
DizzinessNervous system disorders3/613/615/623/63
PyrexiaGeneral disorders2/614/610/620/63
Procedural hypotensionInjury, poisoning and procedural complications4/613/612/623/63
Blood pressure decreasedInvestigations0/614/613/622/63
NauseaGastrointestinal disorders0/611/614/621/63
VomitingGastrointestinal disorders1/611/614/623/63

Baseline characteristics

One subject of 1.0 μg/kg group was excluded from FAS due to deviation from one of the inclusion criteria. So, there is a discrepancy between the number of subjects in "Participant flow" and in "Overall Number of Baseline Participants".

Age, Categorical
Age, Categorical(Participants)0.25 μg/kg Group0.5 μg/kg Group1.0 μg/kg GroupPlacebo GroupTotal
<=18 years00000
Between 18 and 65 years23252930107
>=65 years38363233139
Age, Continuous
Age, Continuous(years)0.25 μg/kg Group0.5 μg/kg Group1.0 μg/kg GroupPlacebo GroupTotal
Mean64.2 ± 11.265.6 ± 11.464.4 ± 11.764.1 ± 12.764.5 ± 11.7
Sex: Female, Male
Sex: Female, Male(Participants)0.25 μg/kg Group0.5 μg/kg Group1.0 μg/kg GroupPlacebo GroupTotal
Female1116142061
Male50454743185
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)0.25 μg/kg Group0.5 μg/kg Group1.0 μg/kg GroupPlacebo GroupTotal
Hispanic or Latino00000
Not Hispanic or Latino61616163246
Unknown or Not Reported00000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)0.25 μg/kg Group0.5 μg/kg Group1.0 μg/kg GroupPlacebo GroupTotal
American Indian or Alaska Native00000
Asian61616163246
Native Hawaiian or Other Pacific Islander00000
Black or African American00000
White00000
More than one race00000
Unknown or Not Reported00000
Region of Enrollment
Region of Enrollment(participants)0.25 μg/kg Group0.5 μg/kg Group1.0 μg/kg GroupPlacebo GroupTotal
Japan61616163246
Dry weight at the start of Sceening
Dry weight at the start of Sceening(kg)0.25 μg/kg Group0.5 μg/kg Group1.0 μg/kg GroupPlacebo GroupTotal
Mean61.25 ± 13.8659.98 ± 11.2262.85 ± 13.3960.63 ± 12.7161.17 ± 12.80
Hemodialysis History
Hemodialysis History(years)0.25 μg/kg Group0.5 μg/kg Group1.0 μg/kg GroupPlacebo GroupTotal
Mean7.0 ± 6.56.7 ± 7.27.7 ± 6.56.8 ± 6.17.1 ± 6.5

2 further baseline measures are reported on the registry.

07

Study locations

1 site
  • Research Site
    Multiple Locations, Japan
08

References and documents

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. PubMed 35511180 ↗

Study documents

  • Study protocol · Nov 29, 2018
  • Statistical analysis plan · Jan 20, 2020

Documents are hosted by the registry — open the source record to download them.

09

Registry details

Key details

Study ID
NCT03802617
Lead sponsor
Kissei Pharmaceutical Co., Ltd.
Collaborators
Maruishi Pharmaceutical
Responsible party
Sponsor
First posted
Jan 14, 2019
Start date
Feb 1, 2019
Primary completion
Oct 22, 2019
Completion
Oct 22, 2019
Results posted
Dec 5, 2025
Last update
Dec 5, 2025

Study contacts

Naomi Koshihara
study director · Clinical Development Div.

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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