Trial · NCT04711603
A Phase III Clinical Study of MR13A9 in Hemodialysis Patients With Pruritus.
NCT04711603, Phase 3, Completed, Kissei Pharmaceutical Co., Ltd.; results first posted 2025-09-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase III Clinical Study of MR13A9 in Hemodialysis Patients With Pruritus. Trials, record NCT04711603. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04711603
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase III Clinical Study of MR13A9 in Hemodialysis Patients With Pruritus.
- NCT number
- NCT04711603
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 178 participants, actual
- Lead sponsor
- Kissei Pharmaceutical Co., Ltd.
- Conditions
- Uremic Pruritus
- Interventions
- MR13A9, Placebo
- First posted
- 2021-01-15
- Last updated
- 2025-09-10
- Results first posted
- 2025-09-10
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 4 | 4 weeks | The change from baseline in the mean NRS score at each time point was calculated using an MMRM with the change from baseline in the mean NRS score at each time point as an objective variable, group, time point, and group-by-time point interaction as fixed effects, mean NRS score at baseline and presence or absence of prior treatment with nalfurafine hydrochloride as dynamic allocation factors as a covariate, and subjects as a random effect for data up to Week 4 of the double-blind period in FAS. 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 4 | 4 weeks | points | MEAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in the Mean NRS Score at Week 4 | MR13A9 0.5 μg/kg Group | -2.06 | Standard Error 0.20 | points | |
| Change From Baseline in the Mean NRS Score at Week 4 | Placebo Group | -1.09 | Standard Error 0.20 | points |
Source ClinicalTrials.gov
Participant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-blind Period (6 Weeks) | STARTED | Double Blind Period: MR13A9 0.5 μg/kg Group | 89 | |
| Double-blind Period (6 Weeks) | STARTED | Double Blind Period: Placebo Group | 89 | |
| Double-blind Period (6 Weeks) | STARTED | Entire Study: MR13A9/MR13A9 Group | 0 | |
| Double-blind Period (6 Weeks) | STARTED | Entire Study: Placebo/MR13A9 Group | 0 | |
| Double-blind Period (6 Weeks) | COMPLETED | Double Blind Period: MR13A9 0.5 μg/kg Group | 85 | |
| Double-blind Period (6 Weeks) | COMPLETED | Double Blind Period: Placebo Group | 83 | |
| Double-blind Period (6 Weeks) | COMPLETED | Entire Study: MR13A9/MR13A9 Group | 0 | |
| Double-blind Period (6 Weeks) | COMPLETED | Entire Study: Placebo/MR13A9 Group | 0 | |
| Double-blind Period (6 Weeks) | NOT COMPLETED | Double Blind Period: MR13A9 0.5 μg/kg Group | 4 | |
| Double-blind Period (6 Weeks) | NOT COMPLETED | Double Blind Period: Placebo Group | 6 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events376
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 | Double Blind Period: MR13A9 0.5 μg/kg Group | 4 | 89 | 4 |
| other | Constipation | Gastrointestinal disorders | Double Blind Period: Placebo Group | 1 | 89 | 1 |
| other | Constipation | Gastrointestinal disorders | Entire Study: MR-MR Group | 12 | 85 | 13 |
| other | Constipation | Gastrointestinal disorders | Entire Study: P-MR Group | 8 | 83 | 11 |
| other | Diarrhoea | Gastrointestinal disorders | Double Blind Period: MR13A9 0.5 μg/kg Group | 2 | 89 | 2 |
| other | Diarrhoea | Gastrointestinal disorders | Double Blind Period: Placebo Group | 3 | 89 | 4 |
| other | Diarrhoea | Gastrointestinal disorders | Entire Study: MR-MR Group | 11 | 85 | 18 |
| other | Diarrhoea | Gastrointestinal disorders | Entire Study: P-MR Group | 18 | 83 | 26 |
| other | Haemorrhoids | Gastrointestinal disorders | Double Blind Period: MR13A9 0.5 μg/kg Group | 0 | 89 | 0 |
| other | Haemorrhoids | Gastrointestinal disorders | Double Blind Period: Placebo Group | 0 | 89 | 0 |
1 to 10 of 376Source ClinicalTrials.gov
See all 376 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Double Blind Period: MR13A9 0.5 μg/kg Group | 0 | 89 |
| Total, all-cause mortality | Double Blind Period: Placebo Group | 1 | 89 |
| Total, all-cause mortality | Entire Study: MR-MR Group | 2 | 85 |
| Total, all-cause mortality | Entire Study: P-MR Group | 2 | 83 |
| Total, other adverse events | Double Blind Period: MR13A9 0.5 μg/kg Group | 27 | 89 |
| Total, other adverse events | Double Blind Period: Placebo Group | 24 | 89 |
| Total, other adverse events | Entire Study: MR-MR Group | 74 | 85 |
| Total, other adverse events | Entire Study: P-MR Group | 74 | 83 |
| Total, serious adverse events | Double Blind Period: MR13A9 0.5 μg/kg Group | 7 | 89 |
| Total, serious adverse events | Double Blind Period: Placebo Group | 10 | 89 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38320524 | 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.
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/NCT04711603
GET https://conductscience.org/api/trials/v1/NCT04711603/flow?page=2