Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2025-12-25 @ 8:06 PM
Study NCT ID:
NCT06206135
Status:
RECRUITING
Last Update Posted:
2024-04-29
First Post:
2023-12-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multicenter, Open, Prospective, 48 Weeks, Observational Study ,Evaluate the Safety and Efficacy of Nephoxil Capsule
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': 100}, 'targetDuration': '48 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-25', 'studyFirstSubmitDate': '2023-12-17', 'studyFirstSubmitQcDate': '2024-01-04', 'lastUpdatePostDateStruct': {'date': '2024-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ratio of reached target serum phosphorus level (3.5 - 5.5 mg/dL) at week 48', 'timeFrame': '48 weeks', 'description': 'Ratio of reached target serum phosphorus level (3.5 - 5.5 mg/dL) at week 48'}], 'secondaryOutcomes': [{'measure': 'Ratio of subjects whose average serum phosphorus levels at Weeks 40, 44, and 48 reached the target serum phosphorus level (3.5 - 5.5 mg/dL)', 'timeFrame': '40 ~ 48 weeks', 'description': 'Ratio of subjects whose average serum phosphorus levels at Weeks 40, 44, and 48 reached the target serum phosphorus level (3.5 - 5.5 mg/dL)'}, {'measure': 'Mean change from baseline to week 48 in serum phosphorus level', 'timeFrame': '48 weeks', 'description': 'Mean change from baseline to week 48 in serum phosphorus level'}, {'measure': 'Initial dose retention period', 'timeFrame': 'Up to 48weeks', 'description': 'Initial dose retention period'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hyperphosphatemia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and efficacy of Nephoxil capsule administration for the improvement of hyperphosphatemia in CKD patients undergoing hemodialysis under actual conditions of routine medical care.', 'detailedDescription': "This study is a prospective observational study, and only observable information is collected during Visits 1 to 13 of the subjects' routine outpatient visits. Therefore, no further visits related to this study are planned, and all treatments, examinations, and evaluations necessary for the subjects shall be conducted at the discretion of the investigator.\n\nThe initial dose of Nephoxil capsules for the subjects participating in this study shall be determined at the investigator's discretion, and subjects shall be classified into either the low-dose group (1.5 g/day) or the standard-dose group (4 g/day) according to the initial dose. During the observation period, dose titration within 1 g may be performed at the investigator's discretion, and in such cases, the maximum dose per day shall not exceed 6 g."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Hyperphosphatemia in patients with CKD undergoing hemodialysis', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adults 19 years of age or older as of the ICF date\n2. CKD patients undergoing hemodialysis to whom Nephoxil capsule shall be administered for the first time for the treatment of hyperphosphatemia as per the determination of the investigator\n3. Patients who voluntarily decide to participate in this study and complete the ICF\n\nExclusion Criteria:\n\n1. Those who fall under the "Do not administer to the following patients" criteria according to Nephoxil capsule indication approval\n2. Those who require concomitant administration of aluminum-containing medication\n3. Others determined by the investigator to be unsuitable for participation in this study'}, 'identificationModule': {'nctId': 'NCT06206135', 'briefTitle': 'Multicenter, Open, Prospective, 48 Weeks, Observational Study ,Evaluate the Safety and Efficacy of Nephoxil Capsule', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kyowa Kirin Co., Ltd.'}, 'officialTitle': 'Multicenter, Open, Prospective, 48 Weeks, Observational Study in the Real-world to Evaluate the Safety and Efficacy of Nephoxil Capsule for Treatment of Hyperphosphatemia in Chronic Kidney Disease Patients on Dialysis', 'orgStudyIdInfo': {'id': 'KKKR-Nephoxil OS-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'low-dose group', 'description': 'initial dose 1.5 g/day', 'interventionNames': ['Drug: the low-dose group (1.5 g/day) or the standard-dose group (4 g/day)']}, {'label': 'standard-dose group', 'description': 'initial dose 4 g/day', 'interventionNames': ['Drug: the low-dose group (1.5 g/day) or the standard-dose group (4 g/day)']}], 'interventions': [{'name': 'the low-dose group (1.5 g/day) or the standard-dose group (4 g/day)', 'type': 'DRUG', 'description': "The initial dose of Nephoxil capsules for the subjects participating in this study shall be determined at the investigator's discretion, and subjects shall be classified into either the low-dose group (1.5 g/day) or the standard-dose group (4 g/day) according to the initial dose. It will be conducted with 13 visits over 48 weeks.", 'armGroupLabels': ['low-dose group', 'standard-dose group']}]}, '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'}], 'overallOfficials': [{'name': 'hyeokjun choi', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kyowa Kirin Korea Co., Ltd.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Undecided'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyowa Kirin Korea Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}