Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 10:49 PM
Study NCT ID:
NCT00527267
Status:
COMPLETED
Last Update Posted:
2009-01-26
First Post:
2007-09-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Study of AMG 073 in Hemodialysis Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006961', 'term': 'Hyperparathyroidism'}], 'ancestors': [{'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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 320}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'completionDateStruct': {'date': '2003-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-01-22', 'studyFirstSubmitDate': '2007-09-06', 'studyFirstSubmitQcDate': '2007-09-06', 'lastUpdatePostDateStruct': {'date': '2009-01-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the efficacy of AMG 073 compared with placebo by determining the proportion of subjects with a mean intact parathyroid hormone (iPTH) value <= 250 pg/mL (26.5 pmol/L) during the efficacy assessment phase.', 'timeFrame': 'Efficacy Assessment Phase - last 14 weeks of study'}], 'secondaryOutcomes': [{'measure': 'To evaluate the efficacy of AMG 073 compared with placebo by determining: the proportion of subjects with a reduction from baseline in iPTH of >= during the efficacy assessment phase', 'timeFrame': 'Efficacy Assessment Phase - last 14 weeks of study'}, {'measure': 'To evaluate the efficacy of AMG 073 compared with placebo by determining: percentage change from baseline in calcium x phosphorus (Ca x P) during the efficacy assessment phase', 'timeFrame': 'Efficacy Assessment Phase - last 14 weeks of study'}, {'measure': 'To evaluate the efficacy of AMG 073 compared with placebo by determining: changes in self-reported cognitive function from baseline to the end of the efficacy assessment phase', 'timeFrame': 'Efficacy Assessment Phase - last 14 weeks of study'}, {'measure': 'To evaluate the safety of AMG 073 compared with placebo.', 'timeFrame': 'Entire study - 26 weeks'}]}, 'conditionsModule': {'conditions': ['Hyperparathyroidism']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://download.veritasmedicine.com/REGFILES/amgen/Amgen_results_disclaimer.pdf', 'label': 'Notice regarding posted summaries of trial results'}, {'url': 'http://download.veritasmedicine.com/REGFILES/amgen/08D_FDAMA_113_Posting_Summary_38_AMG_073_20000183.pdf', 'label': 'To access clinical trial results information click on this link'}, {'url': 'http://www.sensipar.com/', 'label': 'FDA-approved Drug Labeling'}, {'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': 'Subjects on Hemodialysis will be randomized to AMG 073 or placebo. The screening period is a maximum of 30 days followed by a 26-week treatment period. Lab assessments will be completed throughout the study along with PRO assessments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and Women greater than or equal to 18 years of age\n* Using effective contraceptive measures\n* Mean iPTH during screening of greater than or equal to 300 pg/mL\n* Mean calcium during screening of greater than or equal to 8.4 mg/dL\n* Stable on hemodialysis\n\nExclusion Criteria:\n\n* Unstable medical conditions\n* Parathyroidectomy within 3 months\n* Change in Vitamin D therapy\n* Receiving antidepressants\n* Experienced an MI within 3 months\n* Inability to swallow tablets\n* Previously received AMG 073'}, 'identificationModule': {'nctId': 'NCT00527267', 'briefTitle': 'Safety and Efficacy Study of AMG 073 in Hemodialysis Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'A Phase 3 Study to Assess the Efficacy and Safety of an Oral Calcimimetic Agent (AMG 073) in Secondary Hyperparathyroidism of End Stage Renal Disease Treated With Hemodialysis', 'orgStudyIdInfo': {'id': '20000183'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AMG 073', 'description': 'AMG 073', 'interventionNames': ['Drug: AMG 073']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': '30 mg placebo once daily orally 60 mg placebo once daily orally 90 mg placebo once daily orally 120 mg placebo once daily orally 180 mg placebo once daily orally', 'armGroupLabels': ['Placebo']}, {'name': 'AMG 073', 'type': 'DRUG', 'description': '30 mg AMG 073 once daily 60 mg AMG 073 once daily 90 mg AMG 073 once daily 120 mg AMG 073 once daily 180 mg AMG 073 once daily', 'armGroupLabels': ['AMG 073']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amgen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amgen', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Global Development Leader', 'oldOrganization': 'Amgen Inc.'}}}}