Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-26 @ 1:05 AM
Study NCT ID:
NCT06186934
Status:
RECRUITING
Last Update Posted:
2024-04-29
First Post:
2023-12-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Post Marketing Surveillance Study to Observe Safety and Effectiveness of NEPHOXIL ® in S. Korea Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054559', 'term': 'Hyperphosphatemia'}], 'ancestors': [{'id': 'D010760', 'term': 'Phosphorus Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D044382', 'term': 'Population Groups'}], 'ancestors': [{'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'targetDuration': '8 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2026-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-25', 'studyFirstSubmitDate': '2023-12-17', 'studyFirstSubmitQcDate': '2023-12-17', 'lastUpdatePostDateStruct': {'date': '2024-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum phosphorus levels', 'timeFrame': '8 weeks', 'description': 'Effectiveness evaluation is performed based on Serum phosphorus levels (mg/dL) before and after Nephoxil administration. We collect the most recent measurements prior to the initial administration, and measurements after at least four and eight weeks of administration of Nephoxil'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hyperphosphatemia']}, 'descriptionModule': {'briefSummary': 'The objective of this post-marketing surveillance (PMS) study is to assess the safety and effectiveness of Nephoxil capsule 500 mg (Ferric Citrate 500 mg, equivalent to 105 mg Ferric Iron) in routine clinical settings'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with chronic kidney disease undergoing hemodialysis and controlling hyperphosphatemia', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adults 19 years of age or older\n2. CKD patients undergoing hemodialysis to whom Nephoxil capsule administration is deemed necessary for improvement of hyperphosphatemia as per the determination of the investigator\n3. Patients who received Nephoxil capsule for the first time according to the national approval after conclusion of the contract with the study institution\n4. Those (or his / her legal guardian) who have agreed in writing to participate in the survey\n\nExclusion Criteria:\n\n1. Patients with contraindications to receive Nephoxil\n\n * Patients with hypersensitivity to the active substance or to any of the excipients\n * Patients with hypophosphatemia\n * Patients with abnormal iron metabolism or symptoms of excessive iron (e.g. hemochromatosis)\n2. Patients who intend to use this drug for non-approved indications\n3. Patients who participated in pre-market clinical trials with Nephoxil\n4. Patients who took this drug before the starting day of this survey'}, 'identificationModule': {'nctId': 'NCT06186934', 'briefTitle': 'Post Marketing Surveillance Study to Observe Safety and Effectiveness of NEPHOXIL ® in S. Korea Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kyowa Kirin Co., Ltd.'}, 'officialTitle': 'Post Marketing Surveillance Study to Observe Safety and Effectiveness of NEPHOXIL ® in S. Korea Patients', 'orgStudyIdInfo': {'id': 'Nephoxil PMS'}}, 'armsInterventionsModule': {'interventions': [{'name': 'the standard-dose group (4 g/day)', 'type': 'DRUG', 'description': 'Patients with chronic kidney disease undergoing hemodialysis and controlling hyperphosphatemia'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jeonju', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Ayeong cho', 'role': 'CONTACT', 'email': 'loveharuka@naver.com'}], 'facility': 'Jesus Hospital', 'geoPoint': {'lat': 35.82194, 'lon': 127.14889}}], 'centralContacts': [{'name': 'hyeokjun choi', 'role': 'CONTACT', 'email': 'hyeokjun.choi.2j@kyowakirin.com', 'phone': '01074713471'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Undecided'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyowa Kirin Korea Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}