Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2026-03-31 @ 2:21 AM
Study NCT ID:
NCT00990704
Status:
COMPLETED
Last Update Posted:
2011-07-11
First Post:
2009-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Paricalcitol Compared to Maxacalcitol in Chronic Kidney Disease Patients With Secondary Hyperparathyroidism
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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': 'C084656', 'term': 'paricalcitol'}, {'id': 'C051883', 'term': 'maxacalcitol'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-633-9110', 'title': 'Global Medical Services', 'organization': 'Abbott'}, 'certainAgreement': {'otherDetails': 'Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Paricalcitol', 'description': '2 mcg with incremental of 1 mcg', 'otherNumAtRisk': 14, 'otherNumAffected': 14, 'seriousNumAtRisk': 14, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Maxacalcitol', 'description': '5 or 10 mcg with incremental of 2.5 mcg', 'otherNumAtRisk': 33, 'otherNumAffected': 31, 'seriousNumAtRisk': 33, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Eye pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Scleritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Gingivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Stomach discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Injection site dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Excoriation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Procedural hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Shunt stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Blood pressure decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Serum ferritin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hypercalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 12}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hyperphosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 11}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pharyngolaryngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Haemorrhage subcutaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hyperkeratosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Skin chapped', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Skin exfoliation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'seriousEvents': [{'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Vitreous haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pyothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Skin papilloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Lumbar spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Percentage of Participants With a >=50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline Compared to the Average iPTH Obtained in the Last 3 Weeks.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Paricalcitol', 'description': '2 mcg with incremental of 1 mcg'}, {'id': 'OG001', 'title': 'Maxacalcitol', 'description': '5 or 10 mcg with incremental of 2.5 mcg'}], 'classes': [{'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '36.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.518', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference between arms in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.6', 'ciLowerLimit': '-22.36', 'ciUpperLimit': '49.63', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and the last 3 weeks (Weeks 11, 12, and 13)', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who received at least 1 dose of study drug and who had at least 1 iPTH measurement while on treatment.'}, {'type': 'SECONDARY', 'title': 'The Percentage of Participants With iPTH Within Target Range of 60-180 pg/mL, Based on the Average iPTH Obtained in the Last 3 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Paricalcitol', 'description': '2 mcg with incremental of 1 mcg'}, {'id': 'OG001', 'title': 'Maxacalcitol', 'description': '5 or 10 mcg with incremental of 2.5 mcg'}], 'classes': [{'categories': [{'measurements': [{'value': '28.6', 'groupId': 'OG000'}, {'value': '15.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the last 3 weeks (Weeks 11, 12, and 13)', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean iPTH at Each Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Paricalcitol', 'description': '2 mcg with incremental of 1 mcg'}, {'id': 'OG001', 'title': 'Maxacalcitol', 'description': '5 or 10 mcg with incremental of 2.5 mcg'}], 'classes': [{'title': 'Screening (up to 2 weeks before Baseline)', 'categories': [{'measurements': [{'value': '462.7', 'spread': '127.62', 'groupId': 'OG000'}, {'value': '536.4', 'spread': '190.72', 'groupId': 'OG001'}]}]}, {'title': 'Baseline (Week 1)', 'categories': [{'measurements': [{'value': '507.6', 'spread': '162.47', 'groupId': 'OG000'}, {'value': '595.9', 'spread': '213.80', 'groupId': 'OG001'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '479.2', 'spread': '178.43', 'groupId': 'OG000'}, {'value': '474.8', 'spread': '201.00', 'groupId': 'OG001'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '474.4', 'spread': '201.98', 'groupId': 'OG000'}, {'value': '381.8', 'spread': '181.07', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '401.3', 'spread': '209.24', 'groupId': 'OG000'}, {'value': '310.2', 'spread': '158.68', 'groupId': 'OG001'}]}]}, {'title': 'Week 5', 'categories': [{'measurements': [{'value': '373.2', 'spread': '181.64', 'groupId': 'OG000'}, {'value': '279.7', 'spread': '155.07', 'groupId': 'OG001'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '304.8', 'spread': '136.76', 'groupId': 'OG000'}, {'value': '262.3', 'spread': '144.72', 'groupId': 'OG001'}]}]}, {'title': 'Week 7', 'categories': [{'measurements': [{'value': '282.2', 'spread': '152.76', 'groupId': 'OG000'}, {'value': '292.8', 'spread': '187.02', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '256.9', 'spread': '142.39', 'groupId': 'OG000'}, {'value': '315.1', 'spread': '229.53', 'groupId': 'OG001'}]}]}, {'title': 'Week 9', 'categories': [{'measurements': [{'value': '275.9', 'spread': '158.39', 'groupId': 'OG000'}, {'value': '358.8', 'spread': '252.98', 'groupId': 'OG001'}]}]}, {'title': 'Week 10', 'categories': [{'measurements': [{'value': '312.6', 'spread': '140.45', 'groupId': 'OG000'}, {'value': '361.2', 'spread': '228.37', 'groupId': 'OG001'}]}]}, {'title': 'Week 11', 'categories': [{'measurements': [{'value': '279.6', 'spread': '159.69', 'groupId': 'OG000'}, {'value': '345.1', 'spread': '189.52', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '291.5', 'spread': '163.51', 'groupId': 'OG000'}, {'value': '341.6', 'spread': '192.65', 'groupId': 'OG001'}]}]}, {'title': 'Week 13', 'categories': [{'measurements': [{'value': '293.0', 'spread': '164.74', 'groupId': 'OG000'}, {'value': '326.4', 'spread': '180.33', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening (up to 2 weeks before Baseline) to Week 13', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Change in iPTH From Baseline to the Average iPTH Obtained in the Last 3 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Paricalcitol', 'description': '2 mcg with incremental of 1 mcg'}, {'id': 'OG001', 'title': 'Maxacalcitol', 'description': '5 or 10 mcg with incremental of 2.5 mcg'}], 'classes': [{'categories': [{'measurements': [{'value': '-208.4', 'spread': '136.70', 'groupId': 'OG000'}, {'value': '-240.4', 'spread': '152.73', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and the last 3 weeks (Weeks 11, 12, and 13)', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a >= 50% Reduction in iPTH From Baseline to the Average iPTH Obtained in the Last 3 Weeks and Without Hypercalcemia During Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Paricalcitol', 'description': '2 mcg with incremental of 1 mcg'}, {'id': 'OG001', 'title': 'Maxacalcitol', 'description': '5 or 10 mcg with incremental of 2.5 mcg'}], 'classes': [{'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and the last 3 weeks (Weeks 11, 12, and 13) for iPTH and anytime during the 12-week treatment period for hypercalcemia', 'description': 'Hypercalcemia was defined as at least 1 corrected calcium \\> 11.5 mg/dL or at least 2 consecutive corrected calcium \\>= 11.0 mg/dL.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With iPTH Within the Target Range of 60-180 pg/mL Based on the Average iPTH Obtained in the Last 3 Weeks of the Study and Without Hypercalcemia Anytime During Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Paricalcitol', 'description': '2 mcg with incremental of 1 mcg'}, {'id': 'OG001', 'title': 'Maxacalcitol', 'description': '5 or 10 mcg with incremental of 2.5 mcg'}], 'classes': [{'categories': [{'measurements': [{'value': '28.6', 'groupId': 'OG000'}, {'value': '12.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and the last 3 weeks (Weeks 11, 12, and 13) for iPTH and anytime during the 12-week treatment period for hypercalcemia', 'description': 'Hypercalcemia was defined as at least 1 corrected calcium \\> 11.5 mg/dL or at least 2 consecutive corrected calcium \\>= 11.0 mg/dL.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Occurrences of iPTH Control, Defined as >=50% Reduction in iPTH From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Paricalcitol', 'description': '2 mcg with incremental of 1 mcg'}, {'id': 'OG001', 'title': 'Maxacalcitol', 'description': '5 or 10 mcg with incremental of 2.5 mcg'}], 'classes': [{'categories': [{'measurements': [{'value': '3.4', 'spread': '2.98', 'groupId': 'OG000'}, {'value': '4.8', 'spread': '2.96', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Over the 12-week treatment period', 'unitOfMeasure': 'Occurrences per participant', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Occurrences of iPTH Control, Defined as Within the Target Range of 60-180 pg/mL of iPTH', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Paricalcitol', 'description': '2 mcg with incremental of 1 mcg'}, {'id': 'OG001', 'title': 'Maxacalcitol', 'description': '5 or 10 mcg with incremental of 2.5 mcg'}], 'classes': [{'categories': [{'measurements': [{'value': '2.3', 'spread': '2.70', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '2.67', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Over the 12-week treatment period', 'unitOfMeasure': 'Occurrences per participant', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Paricalcitol', 'description': '2 mcg with incremental of 1 mcg'}, {'id': 'FG001', 'title': 'Maxacalcitol', 'description': '5 or 10 mcg with incremental of 2.5 mcg'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Informed consent was obtained from 92 subjects; 45 of these subjects were not enrolled because they did not meet the eligibility criteria at the time of Screening.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Paricalcitol', 'description': '2 mcg with incremental of 1 mcg'}, {'id': 'BG001', 'title': 'Maxacalcitol', 'description': '5 or 10 mcg with incremental of 2.5 mcg'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.9', 'spread': '11.02', 'groupId': 'BG000'}, {'value': '61.5', 'spread': '9.73', 'groupId': 'BG001'}, {'value': '62.5', 'spread': '10.13', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-30', 'studyFirstSubmitDate': '2009-10-05', 'resultsFirstSubmitDate': '2011-05-20', 'studyFirstSubmitQcDate': '2009-10-06', 'lastUpdatePostDateStruct': {'date': '2011-07-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-05-20', 'studyFirstPostDateStruct': {'date': '2009-10-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-06-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Percentage of Participants With a >=50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline Compared to the Average iPTH Obtained in the Last 3 Weeks.', 'timeFrame': 'Baseline and the last 3 weeks (Weeks 11, 12, and 13)'}], 'secondaryOutcomes': [{'measure': 'The Percentage of Participants With iPTH Within Target Range of 60-180 pg/mL, Based on the Average iPTH Obtained in the Last 3 Weeks', 'timeFrame': 'During the last 3 weeks (Weeks 11, 12, and 13)'}, {'measure': 'Mean iPTH at Each Visit', 'timeFrame': 'Screening (up to 2 weeks before Baseline) to Week 13'}, {'measure': 'Mean Change in iPTH From Baseline to the Average iPTH Obtained in the Last 3 Weeks', 'timeFrame': 'Baseline and the last 3 weeks (Weeks 11, 12, and 13)'}, {'measure': 'Percentage of Participants With a >= 50% Reduction in iPTH From Baseline to the Average iPTH Obtained in the Last 3 Weeks and Without Hypercalcemia During Treatment', 'timeFrame': 'Baseline and the last 3 weeks (Weeks 11, 12, and 13) for iPTH and anytime during the 12-week treatment period for hypercalcemia', 'description': 'Hypercalcemia was defined as at least 1 corrected calcium \\> 11.5 mg/dL or at least 2 consecutive corrected calcium \\>= 11.0 mg/dL.'}, {'measure': 'Percentage of Participants With iPTH Within the Target Range of 60-180 pg/mL Based on the Average iPTH Obtained in the Last 3 Weeks of the Study and Without Hypercalcemia Anytime During Treatment', 'timeFrame': 'Baseline and the last 3 weeks (Weeks 11, 12, and 13) for iPTH and anytime during the 12-week treatment period for hypercalcemia', 'description': 'Hypercalcemia was defined as at least 1 corrected calcium \\> 11.5 mg/dL or at least 2 consecutive corrected calcium \\>= 11.0 mg/dL.'}, {'measure': 'Number of Occurrences of iPTH Control, Defined as >=50% Reduction in iPTH From Baseline', 'timeFrame': 'Over the 12-week treatment period'}, {'measure': 'Number of Occurrences of iPTH Control, Defined as Within the Target Range of 60-180 pg/mL of iPTH', 'timeFrame': 'Over the 12-week treatment period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Secondary hyperparathyroidism', 'Hemodialysis', 'paricalcitol', 'maxacalcitol'], 'conditions': ['Secondary Hyperparathyroidism', 'Hemodialysis']}, 'descriptionModule': {'briefSummary': 'This study is a exploratory comparison of the efficacy and safety of paricalcitol injection with maxacalcitol injection in chronic kidney disease participants receiving hemodialysis with secondary hyperparathyroidism.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic kidney disease (CKD) patients with iPTH \\>=300 pg/mL, adjusted calcium \\>=8.4 to \\<10.2 mg/dL, and phosphorus \\<=6.5 mg/dL\n* Patients receiving dialysis 3 times weekly for at least 3 months before informed consent was obtained and scheduled to receive the same hemodialysis during the study period\n* Patients using dialysate with constant concentration of calcium for 4 weeks before informed consent was obtained and receiving phosphate binder with constant dose regimen for 2 weeks before informed consent was obtained\n\nExclusion Criteria:\n\n* Patients taking drugs that affect iPTH, calcium, or bone metabolism\n* Patients with a history of allergic reaction or significant sensitivity to vitamin D\n* Patients who received parathyroidectomy or ethanol infusion within 1 year before informed consent was obtained\n* Patients with malignancy or with clinically significant hepatic disease (liver function tests more than 3 times the upper limit of normal) or with refractory hepatic disease\n* Patients with cardiovascular disease designated as New York Heart Association Class III or IV or with any of the following cardiovascular or cerebrovascular diseases within 6 months before informed consent was obtained:\n\n * Acute coronary syndrome (myocardial infarction or unstable angina) or acute cerebral vascular disease (cerebral infarction or cerebral hemorrhage)\n * Coronary arterial revascularization (such as coronary artery bypass grafting, percutaneous transluminal coronary angioplasty)\n * Cerebral arterial revascularization (such as cerebral aneurysm clipping, cerebral aneurysm embolization, carotid artery endarterectomy)\n * Arteriosclerosis obliterans with rest pain (Fontaine classification III or more severe)\n* Patients with severe hypertension (defined as mean resting blood pressure taken with the patient in a supine position before dialysis and at 6 dialyses sessions before informed consent was obtained: systolic \\>= 180 mmHg and diastolic \\>= 110 mmHg)\n* Patients with uncontrolled diabetes mellitus (defined as mean glycosylated hemoglobin \\>=8% for 3 months before informed consent was obtained)\n* Patients with a history of drug or alcohol abuse within 6 months before informed consent was obtained\n* Patients who require chronic use of cytochrome P450 (CYP3A) inhibitors or inducers\n* Patients who are taking products that contain aluminum 2 weeks before informed consent was obtained\n* Patients who have taken paricalcitol in the past'}, 'identificationModule': {'nctId': 'NCT00990704', 'briefTitle': 'Paricalcitol Compared to Maxacalcitol in Chronic Kidney Disease Patients With Secondary Hyperparathyroidism', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott'}, 'officialTitle': 'Phase II, Open Study, Exploratory Examination of Efficacy and Safety of Paricalcitol Injection and Maxacalcitol Injection in Chronic Kidney Disease Subjects Receiving Hemodialysis With Secondary Hyperparathyroidism', 'orgStudyIdInfo': {'id': 'M11-609'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Paricalcitol', 'description': '2 mcg adjusted by +/- 1 mcg, up to a maximum of 7 mcg, administered 3 times per week through intravenous catheter immediately before completion of dialysis', 'interventionNames': ['Drug: paricalcitol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Maxacalcitol', 'description': '5 or 10 mcg adjusted by +/- 2.5 mcg, up to a maximum of 20 mcg, administered 3 times per week through intravenous catheter immediately before completion of dialysis', 'interventionNames': ['Drug: maxacalcitol']}], 'interventions': [{'name': 'paricalcitol', 'type': 'DRUG', 'otherNames': ['ABT-358', 'Zemplar'], 'description': 'Intravenous administration 3 times a week immediately before completion of dialysis', 'armGroupLabels': ['Paricalcitol']}, {'name': 'maxacalcitol', 'type': 'DRUG', 'description': 'Intravenous administration 3 times a week immediately before completion of dialysis', 'armGroupLabels': ['Maxacalcitol']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Anjo', 'country': 'Japan', 'facility': 'Site Ref # / Investigator 53794', 'geoPoint': {'lat': 34.95828, 'lon': 137.08054}}, {'city': 'Chiba', 'country': 'Japan', 'facility': 'Site Ref # / Investigator 53787', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'city': 'Kumagaya', 'country': 'Japan', 'facility': 'Site Ref # / Investigator 53786', 'geoPoint': {'lat': 36.13497, 'lon': 139.39004}}, {'city': 'Matsumoto', 'country': 'Japan', 'facility': 'Site Ref # / Investigator 53792', 'geoPoint': {'lat': 36.23333, 'lon': 137.96667}}, {'city': 'Mito', 'country': 'Japan', 'facility': 'Site Ref # / Investigator 53784', 'geoPoint': {'lat': 36.35, 'lon': 140.45}}, {'city': 'Nagasaki', 'country': 'Japan', 'facility': 'Site Ref # / Investigator 53796', 'geoPoint': {'lat': 32.75, 'lon': 129.88333}}, {'city': 'Osaka', 'country': 'Japan', 'facility': 'Site Ref # / Investigator 53795', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Sapporo', 'country': 'Japan', 'facility': 'Site Ref # / Investigator 21561', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Site Ref # / Investigator 53789', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Site Ref # / Investigator 53790', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Toyohashi', 'country': 'Japan', 'facility': 'Site Ref # / Investigator 53793', 'geoPoint': {'lat': 34.76667, 'lon': 137.38333}}, {'city': 'Tsuchiura', 'country': 'Japan', 'facility': 'Site Ref # / Investigator 53785', 'geoPoint': {'lat': 36.09047, 'lon': 140.21047}}, {'city': 'Yachiyo', 'country': 'Japan', 'facility': 'Site Ref # / Investigator 53788', 'geoPoint': {'lat': 35.73531, 'lon': 140.12445}}, {'city': 'Yokosuka', 'country': 'Japan', 'facility': 'Site Ref # / Investigator 53791', 'geoPoint': {'lat': 35.28361, 'lon': 139.66722}}], 'overallOfficials': [{'name': 'Moriaki Kubo', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Abbott Japan Co.,Ltd'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Yoshihiko Ueki', 'oldOrganization': 'Abbott'}}}}