Trial · NCT03802617

A Clinical Study of MR13A9 in Hemodialysis Patients With Pruritus.

NCT03802617, Phase 2, Completed, Kissei Pharmaceutical Co., Ltd.; results first posted 2025-12-05

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Clinical Study of MR13A9 in Hemodialysis Patients With Pruritus. Trials, record NCT03802617. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03802617

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Clinical Study of MR13A9 in Hemodialysis Patients With Pruritus.
NCT number: NCT03802617
Status: Completed
Phases: Phase 2
Enrollment: 247 participants, actual
Lead sponsor: Kissei Pharmaceutical Co., Ltd.
Conditions: Uremic Pruritus
Interventions: MR13A9, Placebo
First posted: 2019-01-14
Last updated: 2025-12-05
Results first posted: 2025-12-05

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	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.

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in the Mean NRS Score at Week 8 of the Treatment Period	8 weeks	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 Participants Analyzed.	points	MEAN

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline in the Mean NRS Score at Week 8 of the Treatment Period	0.25 μg/kg Group	-2.97	Standard Error 0.29	points
Change From Baseline in the Mean NRS Score at Week 8 of the Treatment Period	0.5 μg/kg Group	-3.65	Standard Error 0.30	points
Change From Baseline in the Mean NRS Score at Week 8 of the Treatment Period	1.0 μg/kg Group	-3.64	Standard Error 0.30	points
Change From Baseline in the Mean NRS Score at Week 8 of the Treatment Period	Placebo Group	-2.86	Standard Error 0.29	points

Source ClinicalTrials.gov

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	0.25 μg/kg Group	61
Overall Study	STARTED	0.5 μg/kg Group	61
Overall Study	STARTED	1.0 μg/kg Group	62
Overall Study	STARTED	Placebo Group	63
Overall Study	COMPLETED	0.25 μg/kg Group	59
Overall Study	COMPLETED	0.5 μg/kg Group	53
Overall Study	COMPLETED	1.0 μg/kg Group	54
Overall Study	COMPLETED	Placebo Group	59
Overall Study	NOT COMPLETED	0.25 μg/kg Group	2
Overall Study	NOT COMPLETED	0.5 μg/kg Group	8

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events128

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Constipation	Gastrointestinal disorders	0.25 μg/kg Group	5	61	5
other	Constipation	Gastrointestinal disorders	0.5 μg/kg Group	3	61	3
other	Constipation	Gastrointestinal disorders	1.0 μg/kg Group	7	62	7
other	Constipation	Gastrointestinal disorders	Placebo Group	0	63	0
other	Nausea	Gastrointestinal disorders	0.25 μg/kg Group	0	61	0
other	Nausea	Gastrointestinal disorders	0.5 μg/kg Group	1	61	1
other	Nausea	Gastrointestinal disorders	1.0 μg/kg Group	4	62	5
other	Nausea	Gastrointestinal disorders	Placebo Group	1	63	1
other	Vomiting	Gastrointestinal disorders	0.25 μg/kg Group	1	61	1
other	Vomiting	Gastrointestinal disorders	0.5 μg/kg Group	1	61	1

1 to 10 of 128Source ClinicalTrials.gov

See all 128 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	0.25 μg/kg Group	0	61
Total, all-cause mortality	0.5 μg/kg Group	0	61
Total, all-cause mortality	1.0 μg/kg Group	0	62
Total, all-cause mortality	Placebo Group	0	63
Total, other adverse events	0.25 μg/kg Group	30	61
Total, other adverse events	0.5 μg/kg Group	35	61
Total, other adverse events	1.0 μg/kg Group	40	62
Total, other adverse events	Placebo Group	24	63
Total, serious adverse events	0.25 μg/kg Group	3	61
Total, serious adverse events	0.5 μg/kg Group	8	61

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
35511180	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03802617

GET https://conductscience.org/api/trials/v1/NCT03802617/events?page=2

API reference For AI assistants