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| Name | Class |
|---|---|
| Maruishi Pharmaceutical | INDUSTRY |
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Double-blind, Placebo-controlled study to evaluate the dose-response relationship of safety, efficacy and pharmacokinetics of MA13A9 in hemodialysis patients with pruritus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MR13A9 low dose | Experimental |
| |
| MR13A9 medium dose | Experimental |
| |
| MR13A9 high dose | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MR13A9 | Drug | Intravenous administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Naomi Koshihara | Clinical Development Div. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Multiple Locations | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35511180 | Derived | 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. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 0.25 μg/kg Group | The study drug was injected into the venous line of the dialysis circuit at the end of each dialysis session for 8 weeks (3 times weekly, 24 times in total). The injected volume of the study drug was determined based on the subject's dry weight on the day of dosing as below.
|
| FG001 | 0.5 μg/kg Group | The study drug was injected into the venous line of the dialysis circuit at the end of each dialysis session for 8 weeks (3 times weekly, 24 times in total). The injected volume of the study drug was determined based on the subject's dry weight on the day of dosing as below.
|
| FG002 | 1.0 μg/kg Group | The study drug was injected into the venous line of the dialysis circuit at the end of each dialysis session for 8 weeks (3 times weekly, 24 times in total). The injected volume of the study drug was determined based on the subject's dry weight on the day of dosing as below.
|
| FG003 | Placebo Group | The study drug was injected into the venous line of the dialysis circuit at the end of each dialysis session for 8 weeks (3 times weekly, 24 times in total). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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".
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| ID | Title | Description |
|---|---|---|
| BG000 | 0.25 μg/kg Group | The study drug was injected into the venous line of the dialysis circuit at the end of each dialysis session for 8 weeks (3 times weekly, 24 times in total). The injected volume of the study drug was determined based on the subject's dry weight on the day of dosing as below.
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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". | Posted | Mean | Standard Error | points | 8 weeks |
Up to 8 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 0.25 μg/kg Group | The study drug was injected into the venous line of the dialysis circuit at the end of each dialysis session for 8 weeks (3 times weekly, 24 times in total). The injected volume of the study drug was determined based on the subject's dry weight on the day of dosing as below.
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 21.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA version 21.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Development Division | Kissei Pharmaceutical Co., Ltd | Email olly | rinsyousiken@pharm.kissei.co.jp |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 29, 2018 | Oct 5, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 20, 2020 | Sep 12, 2025 | SAP_001.pdf |
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| Placebo | Drug | Intravenous administration |
|
| Lack of Efficacy |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Four consecutive missed doses of the study drug |
|
| BG001 | 0.5 μg/kg Group | The study drug was injected into the venous line of the dialysis circuit at the end of each dialysis session for 8 weeks (3 times weekly, 24 times in total). The injected volume of the study drug was determined based on the subject's dry weight on the day of dosing as below.
|
| BG002 | 1.0 μg/kg Group | The study drug will be injected into the venous line of the dialysis circuit at the end of each dialysis session for 8 weeks (3 times weekly, 24 times in total). The injected volume of the study drug was determined based on the subject's dry weight on the day of dosing as below.
|
| BG003 | Placebo Group | The study drug was injected into the venous line of the dialysis circuit at the end of each dialysis session for 8 weeks (3 times weekly, 24 times in total). |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Dry weight at the start of Sceening | Mean | Standard Deviation | kg |
|
| Hemodialysis History | Mean | Standard Deviation | years |
|
| Disease duration of Itch | Mean | Standard Deviation | years |
|
| Average NRS Score | 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. | Mean | Standard Deviation | points |
|
| ID | Title | Description |
|---|---|---|
| OG000 | 0.25 μg/kg Group | The study drug was injected into the venous line of the dialysis circuit at the end of each dialysis session for 8 weeks (3 times weekly, 24 times in total). The injected volume of the study drug was determined based on the subject's dry weight on the day of dosing as below.
|
| OG001 | 0.5 μg/kg Group | The study drug was injected into the venous line of the dialysis circuit at the end of each dialysis session for 8 weeks (3 times weekly, 24 times in total). The injected volume of the study drug was determined based on the subject's dry weight on the day of dosing as below.
|
| OG002 | 1.0 μg/kg Group | The study drug will be injected into the venous line of the dialysis circuit at the end of each dialysis session for 8 weeks (3 times weekly, 24 times in total). The injected volume of the study drug was determined based on the subject's dry weight on the day of dosing as below.
|
| OG003 | Placebo Group | The study drug was injected into the venous line of the dialysis circuit at the end of each dialysis session for 8 weeks (3 times weekly, 24 times in total). |
|
|
|
| 0 |
| 61 |
| 3 |
| 61 |
| 30 |
| 61 |
| EG001 | 0.5 μg/kg Group | The study drug was injected into the venous line of the dialysis circuit at the end of each dialysis session for 8 weeks (3 times weekly, 24 times in total). The injected volume of the study drug was determined based on the subject's dry weight on the day of dosing as below.
| 0 | 61 | 8 | 61 | 35 | 61 |
| EG002 | 1.0 μg/kg Group | The study drug was injected into the venous line of the dialysis circuit at the end of each dialysis session for 8 weeks (3 times weekly, 24 times in total). The injected volume of the study drug was determined based on the subject's dry weight on the day of dosing as below.
| 0 | 62 | 5 | 62 | 40 | 62 |
| EG003 | Placebo Group | The study drug was injected into the venous line of the dialysis circuit at the end of each dialysis session for 8 weeks (3 times weekly, 24 times in total). | 0 | 63 | 2 | 63 | 24 | 63 |
| Angina pectoris | Cardiac disorders | MedDRA version 21.1 | Non-systematic Assessment |
|
| Angina unstable | Cardiac disorders | MedDRA version 21.1 | Non-systematic Assessment |
|
| Aortic valve stenosis | Cardiac disorders | MedDRA version 21.1 | Non-systematic Assessment |
|
| Congenital cystic kidney disease | Congenital, familial and genetic disorders | MedDRA version 21.1 | Non-systematic Assessment |
|
| Vitreous opacities | Eye disorders | MedDRA version 21.1 | Non-systematic Assessment |
|
| Large intestine polyp | Gastrointestinal disorders | MedDRA version 21.1 | Non-systematic Assessment |
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| Small intestinal obstruction | Gastrointestinal disorders | MedDRA version 21.1 | Non-systematic Assessment |
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| Bacteraemia | Infections and infestations | MedDRA version 21.1 | Non-systematic Assessment |
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| Device related infection | Infections and infestations | MedDRA version 21.1 | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA version 21.1 | Non-systematic Assessment |
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| Osteomyelitis | Infections and infestations | MedDRA version 21.1 | Non-systematic Assessment |
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| Heat illness | Injury, poisoning and procedural complications | MedDRA version 21.1 | Non-systematic Assessment |
|
| Shunt malfunction | Injury, poisoning and procedural complications | MedDRA version 21.1 | Non-systematic Assessment |
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| Shunt occlusion | Injury, poisoning and procedural complications | MedDRA version 21.1 | Non-systematic Assessment |
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| Shunt stenosis | Injury, poisoning and procedural complications | MedDRA version 21.1 | Non-systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA version 21.1 | Non-systematic Assessment |
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| Altered state of consciousness | Nervous system disorders | MedDRA version 21.1 | Non-systematic Assessment |
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| Lacunar infarction | Nervous system disorders | MedDRA version 21.1 | Non-systematic Assessment |
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| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA version 21.1 | Non-systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA version 21.1 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA version 21.1 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA version 21.1 | Non-systematic Assessment |
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| Malaise | General disorders | MedDRA version 21.1 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA version 21.1 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA version 21.1 | Non-systematic Assessment |
|
| Procedural hypotension | Injury, poisoning and procedural complications | MedDRA version 21.1 | Non-systematic Assessment |
|
| Blood pressure decreased | Investigations | MedDRA version 21.1 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 21.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA version 21.1 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA version 21.1 | Non-systematic Assessment |
|
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