Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2026-04-22 @ 3:35 AM
Study NCT ID:
NCT03002233
Status:
COMPLETED
Last Update Posted:
2017-07-21
First Post:
2016-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TRK-820 Study in Subjects on Hemodialysis With or Without Uremic Pruritus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C111212', 'term': 'TRK 820'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-19', 'studyFirstSubmitDate': '2016-12-13', 'studyFirstSubmitQcDate': '2016-12-20', 'lastUpdatePostDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetic parameters: area under the time curve from time zero to 24 hours postdose(AUC0-24h)', 'timeFrame': 'Part A; predose to 24 hours postdose, Part B; predose to 24 hours postdose each dose'}, {'measure': 'Pharmacokinetic parameters: area under the time curve from time zero to the last quantifiable concentration(AUC0-last)', 'timeFrame': 'Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose'}, {'measure': 'Pharmacokinetic parameters: area under the time curve from time zero extrapolated to infinity(AUC0-inf)', 'timeFrame': 'Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose'}, {'measure': 'Pharmacokinetic parameters: maximum observed plasma concentration (Cmax)', 'timeFrame': 'Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose'}, {'measure': 'Pharmacokinetic parameters: time to maximum plasma concentration(Tmax)', 'timeFrame': 'Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose'}, {'measure': 'Pharmacokinetic parameters: apparent elimination half-life in plasma(t½)', 'timeFrame': 'Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose'}, {'measure': 'Pharmacokinetic parameters: plasma concentration at 24 hours postdose(C24h)', 'timeFrame': 'Part A; 24 hours postdose, Part B; 24 hours postdose each dose'}, {'measure': 'Pharmacokinetic parameters: apparent total clearance(CL/F)', 'timeFrame': 'Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose'}, {'measure': 'Pharmacokinetic parameters: terminal elimination rate(λz)', 'timeFrame': 'Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose'}, {'measure': 'Pharmacokinetic parameters: apparent distribution volume(Vz/F)', 'timeFrame': 'Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose'}, {'measure': 'Pharmacokinetic parameters: mean residence time(MRT)', 'timeFrame': 'Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose'}, {'measure': 'Pharmacodynamic parameters: Visual Analogue Scale (VAS) reduction from baseline', 'timeFrame': 'Part B only; Baseline to week 5'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['TRK-820', 'Hemodialysis', 'Uremic Pruritus'], 'conditions': ['Uremic Pruritus']}, 'descriptionModule': {'briefSummary': 'This study is a 2-part study.\n\nPart A is a single-dose, open-label study design to determine the PK, safety and tolerability of 5 μg TRK-820 oral administration in subjects with end-stage renal disease (ESRD) who require hemodialysis.\n\nPart B is a multiple dose, open-label study design to determine the PK, PD, safety and tolerability of multiple doses in subjects with ESRD who require hemodialysis with refractory uremic pruritus (UP). Each subject will receive 3 doses of TRK-820 (2.5, 5 and 10 μg).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult non-smoking male and female subjects (≥ 18 years of age) who have ESRD requiring hemodialysis, at least 3 times a week.\n* Subjects has a clinical diagnosis of UP, which is uncontrolled by current medications or treatments.(Part B only)\n\nExclusion Criteria:\n\n* Subject has a known hypersensitivity to opioids or the ingredients of the study medication.\n* Subject has pruritus other than related to ESRD (i.e., UP).(Part B only)'}, 'identificationModule': {'nctId': 'NCT03002233', 'briefTitle': 'TRK-820 Study in Subjects on Hemodialysis With or Without Uremic Pruritus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Toray Industries, Inc'}, 'officialTitle': 'A Phase 1 Study to Observe Safety and Tolerability of Single and Multiple Doses of TRK-820 in Subjects on Hemodialysis and to Observe the Effect on Uremic Pruritus', 'orgStudyIdInfo': {'id': 'EU820UPC01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TRK-820', 'description': 'PartA: 5 μg PartB: 2.5-10 μg', 'interventionNames': ['Drug: TRK-820']}], 'interventions': [{'name': 'TRK-820', 'type': 'DRUG', 'otherNames': ['Nalfurafine Hydrochloride'], 'armGroupLabels': ['TRK-820']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bulgaria', 'country': 'Bulgaria', 'facility': 'Bulgaria'}, {'city': 'Germany', 'country': 'Germany', 'facility': 'Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Toray Industries, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}