Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2025-12-27 @ 3:53 AM
Study NCT ID:
NCT00454350
Status:
COMPLETED
Last Update Posted:
2015-05-05
First Post:
2007-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 4 Pharmacokinetic Study of Hectorol Injection and Zemplar Injection in CKD Subjects on Hemodialysis
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': 'C042533', 'term': '1 alpha-hydroxyergocalciferol'}, {'id': 'C084656', 'term': 'paricalcitol'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02'}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-04', 'studyFirstSubmitDate': '2007-03-28', 'studyFirstSubmitQcDate': '2007-03-28', 'lastUpdatePostDateStruct': {'date': '2015-05-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetic Study', 'timeFrame': '44 hour interval'}]}, 'conditionsModule': {'keywords': ['Hectorol (doxercalciferol injection)', 'Zemplar (paricalcitol injection)'], 'conditions': ['Secondary Hyperparathyroidism']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.hectorol.com/docs/Hectorol%20Injection%20PI%20Text_2006-01.pdf', 'label': 'US FDA Approved Full Prescribing Information for Hectorol® Injection'}]}, 'descriptionModule': {'briefSummary': 'This study will measure serum levels of the active Vitamin D compound that circulates in hemodialysis subjects treated with either doxercalciferol injection (Hectorol®) or Zemplar® (paricalcitol injection).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The subject must be receiving hemodialysis three times per week for a minimum of three months.\n* The subject must be receiving intravenous doxercalciferol or paricalcitol at each dialysis session (three times weekly) for a minimum of 12 weeks prior to Screening.\n* At Screening Visit the subject's laboratory measurements must be within the following ranges: Serum iPTH measurement between 150-800 pg/mL; Corrected calcium measurement ≤ 10.5 mg/dL; Serum phosphorus measurement ≤ 7 mg/dL\n\nExclusion Criteria:\n\n* Any ongoing use of over the counter or prescription vitamin D preparations except doxercalciferol or paricalcitol injection or multivitamins.\n* History of heparin-induced thrombocytopenia."}, 'identificationModule': {'nctId': 'NCT00454350', 'briefTitle': 'A Phase 4 Pharmacokinetic Study of Hectorol Injection and Zemplar Injection in CKD Subjects on Hemodialysis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Randomized , Open-Label, Cross-over, Pharmacokinetic Study of Doxercalciferol and Paricalcitol Following Multiple Intravenous Injections in Chronic Kidney Disease Subjects on Hemodialysis', 'orgStudyIdInfo': {'id': 'HECT00106'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Hectorol (doxercalciferol injection)', 'type': 'DRUG'}, {'name': 'Zemplar (Paricalcitol injection)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Genzyme, a Sanofi Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genzyme, a Sanofi Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Medical Monitor', 'oldOrganization': 'Genzyme Corporation'}}}}