Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2026-03-02 @ 7:43 AM
Study NCT ID:
NCT02549404
Status:
COMPLETED
Last Update Posted:
2017-07-05
First Post:
2015-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 3 Study of KHK7580
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006962', 'term': 'Hyperparathyroidism, Secondary'}], 'ancestors': [{'id': 'D006961', 'term': 'Hyperparathyroidism'}, {'id': 'D010279', 'term': 'Parathyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 137}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09-28'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2016-12-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-02', 'studyFirstSubmitDate': '2015-09-09', 'studyFirstSubmitQcDate': '2015-09-11', 'lastUpdatePostDateStruct': {'date': '2017-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with adverse events', 'timeFrame': 'Up to 52 weeks', 'description': 'Adverse Event collection and assessment'}], 'secondaryOutcomes': [{'measure': 'Percentage of subjects achieving intact parathyroid hormone (PTH) level of ≥ 60 pg/mL and ≤ 240 pg/mL', 'timeFrame': 'Up to 52 weeks'}, {'measure': 'Percentage of subjects achieving a mean percent decrease in intact PTH level of ≥ 30% (percent change ≤ -30%) from baseline', 'timeFrame': 'Up to 52 weeks'}, {'measure': 'Mean percent change in intact PTH level from baseline', 'timeFrame': 'Up to 52 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Secondary Hyperparathyroidism']}, 'descriptionModule': {'briefSummary': 'This long-term study is designed to evaluate safety and efficacy of KHK7580 orally administered once daily for 52 weeks for patients with secondary hyperparathyroidism receiving hemodialysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Personally submitted written voluntary informed consent to participate in the study\n* Stable chronic renal disease treated with hemodialysis 3 times weekly for at least 12 weeks before screening\n* Intact PTH level of \\> 240 pg/ml at screening (except subjects receiving cinacalcet hydrochloride at screening)\n\nExclusion Criteria:\n\n* Change in dose or dosing regimen of cinacalcet hydrochloride or activated vitamin D drug or its derivative, phosphate binder, or calcium preparation within 2 weeks before screening; or start of treatment with such drugs within 2 weeks before screening;\n* Parathyroidectomy and/or parathyroid intervention within 24 weeks before screening;\n* Severe heart disease;\n* Severe hepatic dysfunction;\n* Uncontrolled hypertension and/or diabetes;\n* Treatment with an investigational product (drug or medical device) in a clinical study or any study equivalent to clinical study within 12 weeks before screening;\n* Primary hyperparathyroidism;\n* Other conditions unfit for participation in this study at the discretion of the investigator or subinvestigator.'}, 'identificationModule': {'nctId': 'NCT02549404', 'briefTitle': 'Phase 3 Study of KHK7580', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kyowa Kirin Co., Ltd.'}, 'officialTitle': 'Phase 3 Study of KHK7580 (A Long-term Study of KHK7580 in Subjects With Secondary Hyperparathyroidism Receiving Hemodialysis)', 'orgStudyIdInfo': {'id': '7580-011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'KHK7580', 'interventionNames': ['Drug: KHK7580']}], 'interventions': [{'name': 'KHK7580', 'type': 'DRUG', 'description': 'Oral administration', 'armGroupLabels': ['KHK7580']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tokyo', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyowa Kirin Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}