Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2025-12-31 @ 9:05 PM
Study NCT ID:
NCT00646932
Status:
COMPLETED
Last Update Posted:
2008-03-31
First Post:
2008-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Paricalcitol Injection Phase II Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C084656', 'term': 'paricalcitol'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-03', 'lastUpdateSubmitDate': '2008-03-26', 'studyFirstSubmitDate': '2008-03-26', 'studyFirstSubmitQcDate': '2008-03-26', 'lastUpdatePostDateStruct': {'date': '2008-03-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics', 'timeFrame': '2 weeks'}], 'secondaryOutcomes': [{'measure': 'Safety', 'timeFrame': '2 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Kidney Disease']}, 'descriptionModule': {'briefSummary': 'The PK and tolerability of paricalcitol after repeated intravenous administration for 2 weeks (total 6 doses at every HD session) are studied in subjects with 2°HPT who are receiving HD 3 times a week for stable chronic renal failure.', 'detailedDescription': 'The purpose of this study is pharmacokinetic \\& tolerability.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with 2°HPT who are receiving HD 3 times a week for stable chronic renal failure\n\nExclusion Criteria:\n\n* Subject is considered by investigator, for any reason, to be an unsuitable candidate for the study'}, 'identificationModule': {'nctId': 'NCT00646932', 'briefTitle': 'Paricalcitol Injection Phase II Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott'}, 'officialTitle': 'A Phase 2, Open-Label, Multicenter, Multi-Dose Study to Evaluate the Pharmacokinetics and Tolerability of Paricalcitol Injection in Chronic Kidney Disease Stage 5 Subjects With Secondary Hyperparathyroidism Undergoing Hemodialysis', 'orgStudyIdInfo': {'id': 'J-ZEM-05-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: paricalcitol']}, {'type': 'EXPERIMENTAL', 'label': '2', 'interventionNames': ['Drug: paricalcitol']}, {'type': 'EXPERIMENTAL', 'label': '3', 'interventionNames': ['Drug: paricalcitol']}, {'type': 'EXPERIMENTAL', 'label': '4', 'interventionNames': ['Drug: paricalcitol']}], 'interventions': [{'name': 'paricalcitol', 'type': 'DRUG', 'otherNames': ['ABT-358', 'Zemplar'], 'description': 'paricalcitol 0.04 mcg/kg three times a week', 'armGroupLabels': ['1']}, {'name': 'paricalcitol', 'type': 'DRUG', 'otherNames': ['ABT-358', 'Zemplar'], 'description': 'paricalcitol 0.08 mcg/kg three times a week', 'armGroupLabels': ['2']}, {'name': 'paricalcitol', 'type': 'DRUG', 'otherNames': ['ABT-358', 'Zemplar'], 'description': 'paricalcitol 0.16 mcg/kg three times a week', 'armGroupLabels': ['3']}, {'name': 'paricalcitol', 'type': 'DRUG', 'otherNames': ['ABT-358', 'Zemplar'], 'description': 'paricalcitol 0.24 mcg/kg three times a week', 'armGroupLabels': ['4']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gunma', 'country': 'Japan'}, {'city': 'Hokkaido', 'country': 'Japan'}, {'city': 'Ibaraki', 'country': 'Japan', 'geoPoint': {'lat': 34.81641, 'lon': 135.56828}}, {'city': 'Kagoshima', 'country': 'Japan', 'geoPoint': {'lat': 31.56667, 'lon': 130.55}}, {'city': 'Kumamoto', 'country': 'Japan', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}, {'city': 'Nagano', 'country': 'Japan', 'geoPoint': {'lat': 36.65, 'lon': 138.18333}}, {'city': 'Nagasaki', 'country': 'Japan', 'geoPoint': {'lat': 32.75, 'lon': 129.88333}}, {'city': 'Saitama', 'country': 'Japan', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}, {'city': 'Shizuoka', 'country': 'Japan', 'geoPoint': {'lat': 34.98333, 'lon': 138.38333}}, {'city': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'Hideaki Harada', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Abbott'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Yoshihiko Ueki', 'oldOrganization': 'Abbott'}}}}