Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2026-01-05 @ 5:33 PM
Study NCT ID:
NCT07285304
Status:
RECRUITING
Last Update Posted:
2025-12-16
First Post:
2025-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Long-term Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2025-11-24', 'studyFirstSubmitQcDate': '2025-12-03', 'lastUpdatePostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of adverse events', 'timeFrame': 'Up to 26 weeks or up to 52 weeks'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hyperphosphatemia Patients on Hemodialysis']}, 'descriptionModule': {'briefSummary': 'A clinical study to evaluate the long-term safety and efficacy of TS-172 in hyperphosphatemia patients on hemodialysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Hyperphosphatemia patients (outpatients) with chronic kidney disease receiving hemodialysis (HD or HDF) 3 times a week for at least 12 weeks prior to Visit 1 (Week -2)\n2. Patients aged ≥18 years at the time of obtaining informed consent\n3. Patients who have been prescribed at least one phosphate binder within the approved dosage, and the prescribed drug and dosage regimen should have been unchanged during the last 2 weeks prior to Visit 1 (Week -2)\n4. Patients with a serum phosphorus concentration of ≥ 3.5 mg/dL and ≤ 7.0 mg/dL at Visit 1 (Week -2) or Visit 2 (Week -1)\n\nExclusion Criteria:\n\n1. Patients with confirmed serum intact PTH concentration \\>500 pg/mL at Visit 1 (Week -2)\n2. Patients who have undergone previous parathyroid intervention (PTx, PEIT, etc.)'}, 'identificationModule': {'nctId': 'NCT07285304', 'briefTitle': 'A Long-term Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Taisho Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Phase 3 Long-term Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis With Phosphate Binders', 'orgStudyIdInfo': {'id': 'TS172-03-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TS-172', 'interventionNames': ['Drug: TS-172']}], 'interventions': [{'name': 'TS-172', 'type': 'DRUG', 'description': 'oral administration of TS-172 20\\~60 mg/day', 'armGroupLabels': ['TS-172']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tokyo', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Taisho Director Taisho Pharmaceutical Co., Ltd selected site', 'role': 'CONTACT', 'email': 'shu_chiken@taisho.co.jp', 'phone': '81-3-3985-1118'}], 'facility': 'Taisho Pharmaceutical Co., Ltd selected site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'centralContacts': [{'name': 'Taisho Pharmaceutical Co., Ltd.', 'role': 'CONTACT', 'email': 'shu_chiken@taisho.co.jp', 'phone': '81-3-3985-1118'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taisho Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}