Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2026-03-14 @ 2:55 AM
Study NCT ID:
NCT02216656
Status:
COMPLETED
Last Update Posted:
2018-07-10
First Post:
2014-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 2 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069449', 'term': 'Cinacalcet'}], 'ancestors': [{'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 201}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-08', 'studyFirstSubmitDate': '2014-08-11', 'studyFirstSubmitQcDate': '2014-08-12', 'lastUpdatePostDateStruct': {'date': '2018-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-08-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The percent changes in intact Parathyroid hormone levels from baseline', 'timeFrame': 'Up to 3 weeks', 'description': 'Percent changes in intact Parathyroid hormone levels from baseline to end of administration period'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in intact Parathyroid hormone , whole Parathyroid hormone, corrected serum Ca, ionized Ca, serum phosphorus, intact fibroblast growth factor 23 and corrected serum Ca X serum phosphorus.', 'timeFrame': 'Up to 3 weeks', 'description': 'Change from baseline in intact Parathyroid hormone , whole Parathyroid hormone, corrected serum Ca, ionized Ca, serum phosphorus, intact fibroblast growth factor 23 and corrected serum Ca X serum phosphorus from baseline to end of administrations period.'}, {'measure': 'Safety', 'timeFrame': 'Up to 3 weeks', 'description': '1. Number and types of adverse events\n2. laboratory tests\n3. vital signs\n4. 12-lead electrocardiogram\n5. ophthalmological examination'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Secondary Hyperparathyroidism']}, 'descriptionModule': {'briefSummary': 'This randomized, placebo-controlled, double-blind (included open arm of KRN1493 (cinacalcet)), parallel-group, multi-center study is designed to evaluate efficacy and safety in cohorts comprising KHK7580, its placebo and KRN1493 (cinacalcet) orally administered for three weeks for secondary hyperparathyroidism patients receiving hemodialysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who have voluntarily consented to participate in this study\n* Subjects with stable chronic renal disease receiving hemodialysis 3 times weekly for at least 12 weeks before screening\n* Subjects with an intact Parathyroid hormone of \\>= 240 pg/mL at screening\n\nExclusion Criteria:\n\n* Subjects with primary hyperparathyroidism\n* Subjects who have received cinacalcet hydrochloride within 2 weeks before screening\n* Subjects whose dose or dosing regimen of an active vitamin D drug or its derivative, phosphate binders, or calcium preparation has been changed or started within 2 weeks before screening.\n* Subjects who have underwent parathyroidectomy and/or parathyroid intervention within 24 weeks before screening.\n* Subjects with uncontrolled hypertension and/or diabetes\n* Subjects with severe heart disease.\n* Subjects with severe hepatic dysfunction.\n* Subjects who have received any other investigational drug within 12 weeks before screening\n* Other subjects unfit for participation in this study in the judgment of the investigator or sub investigator.'}, 'identificationModule': {'nctId': 'NCT02216656', 'briefTitle': 'Phase 2 Study of KHK7580', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kyowa Kirin Co., Ltd.'}, 'officialTitle': 'A Randomized, Double-blind, Parallel-group, Dose-finding Study of KHK7580 for Secondary Hyperparathyroidism Patients Receiving Hemodialysis', 'orgStudyIdInfo': {'id': '7580-005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Plascebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'KHK7580 low dose', 'interventionNames': ['Drug: KHK7580 low dose']}, {'type': 'EXPERIMENTAL', 'label': 'KHK7580 middle dose', 'interventionNames': ['Drug: KHK7580 middle dose']}, {'type': 'EXPERIMENTAL', 'label': 'KHK7580 high dose', 'interventionNames': ['Drug: KHK7580 high dose']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'KRN1493', 'interventionNames': ['Drug: KRN1493']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral administration', 'armGroupLabels': ['Plascebo']}, {'name': 'KHK7580 low dose', 'type': 'DRUG', 'description': 'Oral administration', 'armGroupLabels': ['KHK7580 low dose']}, {'name': 'KHK7580 middle dose', 'type': 'DRUG', 'description': 'Oral administration', 'armGroupLabels': ['KHK7580 middle dose']}, {'name': 'KHK7580 high dose', 'type': 'DRUG', 'description': 'Oral administration', 'armGroupLabels': ['KHK7580 high dose']}, {'name': 'KRN1493', 'type': 'DRUG', 'otherNames': ['cinacalcet'], 'description': 'Oral administration', 'armGroupLabels': ['KRN1493']}]}, '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'}}}}