Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-30 @ 9:14 AM
Study NCT ID:
NCT01382212
Status:
COMPLETED
Last Update Posted:
2018-07-02
First Post:
2011-06-24
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Safety of Paricalcitol Capsules in Pediatric Subjects Ages 10 to 16 With Stage 5 Chronic Kidney Disease Receiving Peritoneal Dialysis or Hemodialysis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Germany', 'Portugal', 'United Kingdom', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}, {'id': 'D006962', 'term': 'Hyperparathyroidism, Secondary'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'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'}, {'id': 'D006961', 'term': 'Hyperparathyroidism'}, {'id': 'D010279', 'term': 'Parathyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C084656', 'term': 'paricalcitol'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-633-9110', 'title': 'Global Medical Information', 'organization': 'AbbVie'}, 'certainAgreement': {'otherDetails': 'AbbVie 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. AbbVie 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 AbbVie needs to secure patent or proprietary protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The sample size of the study was limited to 13 subjects and there was no comparator group, so the study was not designed to analyze efficacy.'}}, 'adverseEventsModule': {'timeFrame': 'Treatment-emergent adverse events were collected from first dose of study drug until 30 days following last dose of study drug (up to 16 weeks); serious adverse events were collected from the time when informed consent was obtained (up to 28 weeks).', 'eventGroups': [{'id': 'EG000', 'title': 'Paricalcitol', 'description': 'Open-label paricalcitol (maximum dose of 16 μg), 3 times weekly (no more frequently than every other day) for 12 weeks.', 'otherNumAtRisk': 13, 'otherNumAffected': 10, 'seriousNumAtRisk': 13, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'ABDOMINAL PAIN UPPER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'INFLUENZA LIKE ILLNESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'UPPER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'ARTERIOVENOUS FISTULA SITE COMPLICATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'PROCEDURAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'PROCEDURAL VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'BLOOD CALCIUM INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'HAEMOGLOBIN DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'HYPERPHOSPHATAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'PAIN IN EXTREMITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'THROAT IRRITATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'PRURITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}], 'seriousEvents': [{'term': 'PERITONEAL DIALYSIS COMPLICATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'FLUID OVERLOAD', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Subjects With Hypercalcemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paricalcitol', 'description': 'Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.3', 'groupId': 'OG000', 'lowerLimit': '1.9', 'upperLimit': '45.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to Week 12', 'description': 'The percentage of subjects with hypercalcemia, defined as at least 2 consecutive post-baseline corrected calcium values \\> 10.2 mg/dL (2.55 mmol/L).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All-treated data set: all subjects enrolled and administered at least 1 dose of paricalcitol'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With 2 Consecutive Intact Parathyroid Hormone (iPTH)/120 Between 150 and 300 pg/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paricalcitol', 'description': 'Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '38.5', 'groupId': 'OG000', 'lowerLimit': '13.9', 'upperLimit': '68.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (last measurement collected prior to the first dose) to Week 12', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All-treated data set'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With 2 Consecutive iPTH Reductions of at Least 30% From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paricalcitol', 'description': 'Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '61.5', 'groupId': 'OG000', 'lowerLimit': '31.6', 'upperLimit': '86.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (last measurement collected prior to the first dose) to Week 12', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All-treated data set'}, {'type': 'SECONDARY', 'title': 'Hemoglobin: Mean Change From Baseline to Final Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paricalcitol', 'description': 'Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.1', 'spread': '1.263', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects in the all-treated data set with evaluable data'}, {'type': 'SECONDARY', 'title': 'Hematocrit: Mean Change From Baseline to Final Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paricalcitol', 'description': 'Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.08', 'spread': '5.066', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects in the all-treated data set with evaluable data'}, {'type': 'SECONDARY', 'title': 'Red Blood Cells: Mean Change From Baseline to Final Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paricalcitol', 'description': 'Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.09', 'spread': '0.496', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)', 'unitOfMeasure': 'cells x 10^6/µL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects in the all-treated data set with evaluable data'}, {'type': 'SECONDARY', 'title': 'White Blood Cells (WBC) and Platelet Count: Mean Change From Baseline to Final Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paricalcitol', 'description': 'Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.'}], 'classes': [{'title': 'WBC', 'categories': [{'measurements': [{'value': '-0.06', 'spread': '2.982', 'groupId': 'OG000'}]}]}, {'title': 'Platelet Count', 'categories': [{'measurements': [{'value': '19.2', 'spread': '47.03', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)', 'unitOfMeasure': 'cells x 10^3/µL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects in the all-treated data set with evaluable data'}, {'type': 'SECONDARY', 'title': 'Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils: Mean Change From Baseline to Final Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paricalcitol', 'description': 'Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.'}], 'classes': [{'title': 'Neutrophils', 'categories': [{'measurements': [{'value': '0.11', 'spread': '2.6812', 'groupId': 'OG000'}]}]}, {'title': 'Lymphocytes', 'categories': [{'measurements': [{'value': '-0.294', 'spread': '0.597', 'groupId': 'OG000'}]}]}, {'title': 'Monocytes', 'categories': [{'measurements': [{'value': '0.032', 'spread': '0.1276', 'groupId': 'OG000'}]}]}, {'title': 'Eosinophils', 'categories': [{'measurements': [{'value': '0.059', 'spread': '0.1522', 'groupId': 'OG000'}]}]}, {'title': 'Basophils', 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.0322', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)', 'unitOfMeasure': 'cells x 10^9/µL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects in the all-treated data set with evaluable data'}, {'type': 'SECONDARY', 'title': 'Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactic Dehydrogenase (LDH), and Bone-Specific Alkaline Phosphatase (BSAP): Mean Change From Baseline to Final Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paricalcitol', 'description': 'Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.'}], 'classes': [{'title': 'ALT (n=11)', 'categories': [{'measurements': [{'value': '-4.55', 'spread': '16.501', 'groupId': 'OG000'}]}]}, {'title': 'AST (n=11)', 'categories': [{'measurements': [{'value': '-4.45', 'spread': '12.25', 'groupId': 'OG000'}]}]}, {'title': 'LDH (n=11)', 'categories': [{'measurements': [{'value': '-6.5', 'spread': '33.22', 'groupId': 'OG000'}]}]}, {'title': 'BSAP (n=9)', 'categories': [{'measurements': [{'value': '-49.4', 'spread': '86.95', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)', 'description': 'n=subjects with evaluable Baseline and Post-baseline data for each parameter.', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects in the all-treated data set with evaluable data'}, {'type': 'SECONDARY', 'title': 'Bilirubin, Blood Urea Nitrogen (BUN), Uric Acid, Magnesium, Glucose, Cholesterol, Triglycerides, High Sensitivity C-Reactive Protein (hsCRP), Inorganic Phosphate, Corrected Calcium, and Creatinine: Mean Change From Baseline to Final Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paricalcitol', 'description': 'Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.'}], 'classes': [{'title': 'Total bilirubin (n=11)', 'categories': [{'measurements': [{'value': '0.032', 'spread': '0.3165', 'groupId': 'OG000'}]}]}, {'title': 'Direct Bilirubin (n=11)', 'categories': [{'measurements': [{'value': '0.013', 'spread': '0.0785', 'groupId': 'OG000'}]}]}, {'title': 'Indirect Bilirubin (n=9)', 'categories': [{'measurements': [{'value': '0.056', 'spread': '0.3035', 'groupId': 'OG000'}]}]}, {'title': 'BUN (n=11)', 'categories': [{'measurements': [{'value': '1.33', 'spread': '11.614', 'groupId': 'OG000'}]}]}, {'title': 'Uric Acid (n=11)', 'categories': [{'measurements': [{'value': '0.31', 'spread': '1.245', 'groupId': 'OG000'}]}]}, {'title': 'Magnesium (n=11)', 'categories': [{'measurements': [{'value': '0.082', 'spread': '0.3649', 'groupId': 'OG000'}]}]}, {'title': 'Glucose (n=11)', 'categories': [{'measurements': [{'value': '4.36', 'spread': '10.172', 'groupId': 'OG000'}]}]}, {'title': 'Cholesterol (n=11)', 'categories': [{'measurements': [{'value': '-16.4', 'spread': '27.37', 'groupId': 'OG000'}]}]}, {'title': 'Triglycerides (n=11)', 'categories': [{'measurements': [{'value': '9.2', 'spread': '40.32', 'groupId': 'OG000'}]}]}, {'title': 'hsCRP (n=11)', 'categories': [{'measurements': [{'value': '0.061', 'spread': '0.1967', 'groupId': 'OG000'}]}]}, {'title': 'Inorganic phosphate (n=13)', 'categories': [{'measurements': [{'value': '0.64', 'spread': '1.188', 'groupId': 'OG000'}]}]}, {'title': 'Corrected Calcium (n=7)', 'categories': [{'measurements': [{'value': '0.31', 'spread': '0.421', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine (n=11)', 'categories': [{'measurements': [{'value': '0.48', 'spread': '1.592', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)', 'description': 'n=subjects with evaluable Baseline and Post-baseline data for each parameter.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects in the all-treated data set with evaluable data'}, {'type': 'SECONDARY', 'title': 'Alkaline Phosphatase: Mean Change From Baseline to Final Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paricalcitol', 'description': 'Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-61.8', 'spread': '117.34', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)', 'unitOfMeasure': 'IU/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects in the all-treated data set with evaluable data'}, {'type': 'SECONDARY', 'title': 'Sodium, Potassium, Chloride, Bicarbonate: Mean Change From Baseline to Final Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paricalcitol', 'description': 'Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.'}], 'classes': [{'title': 'Sodium', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '2.02', 'groupId': 'OG000'}]}]}, {'title': 'Potassium', 'categories': [{'measurements': [{'value': '0.25', 'spread': '0.746', 'groupId': 'OG000'}]}]}, {'title': 'Chloride', 'categories': [{'measurements': [{'value': '0.5', 'spread': '3.21', 'groupId': 'OG000'}]}]}, {'title': 'Bicarbonate', 'categories': [{'measurements': [{'value': '-0.45', 'spread': '3.446', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)', 'unitOfMeasure': 'mEq/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects in the all-treated data set with evaluable data'}, {'type': 'SECONDARY', 'title': 'Total Protein and Albumin: Mean Change From Baseline to Final Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paricalcitol', 'description': 'Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.'}], 'classes': [{'title': 'Total protein (n=11)', 'categories': [{'measurements': [{'value': '0.15', 'spread': '0.43', 'groupId': 'OG000'}]}]}, {'title': 'Albumin (n=13)', 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.325', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)', 'description': 'n=subjects with evaluable Baseline and Post-baseline data for each parameter.', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All-treated data set'}, {'type': 'SECONDARY', 'title': 'Fibroblast Growth Factor-23 (FGF-23), 1,25-Hydroxy Vitamin D, 25-Hydroxy Vitamin D, and Intact Parathyroid Hormone (iPTH): Mean Change From Baseline to Final Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paricalcitol', 'description': 'Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.'}], 'classes': [{'title': 'FGF-23 (n=10)', 'categories': [{'measurements': [{'value': '1990.7', 'spread': '3317.7', 'groupId': 'OG000'}]}]}, {'title': '1,25-Hydroxy Vitamin D (n=11)', 'categories': [{'measurements': [{'value': '15.65', 'spread': '29.296', 'groupId': 'OG000'}]}]}, {'title': '25-Hydroxy Vitamin D (n=11)', 'categories': [{'measurements': [{'value': '5.8', 'spread': '10.38', 'groupId': 'OG000'}]}]}, {'title': 'iPTH (n=13)', 'categories': [{'measurements': [{'value': '-437.5', 'spread': '491.83', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)', 'description': 'n=subjects with evaluable Baseline and Post-baseline data for each parameter.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All-treated data set'}, {'type': 'SECONDARY', 'title': 'Osteocalcin: Mean Change From Baseline to Final Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paricalcitol', 'description': 'Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '117.21', 'spread': '223.07', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects in the all-treated data set with evaluable data'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paricalcitol', 'description': 'Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.'}], 'classes': [{'title': 'Any TEAE', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'TESAE', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose of study drug until 30 days following last dose of study drug (up to 16 weeks).', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All-treated data set'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Potentially Clinically Significant Electrocardiogram (ECG) Findings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paricalcitol', 'description': 'Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 1) to Final Visit (up to Week 12)', 'description': '12-lead ECGs were recorded after the subject had been in the supine position for at least 5 minutes. The number of subjects with potentially clinically significant ECG findings, as determined by the investigator, is presented.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All-treated data set'}, {'type': 'SECONDARY', 'title': 'Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Mean Change From Baseline to Final Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paricalcitol', 'description': 'Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.'}], 'classes': [{'title': 'SBP', 'categories': [{'measurements': [{'value': '7.5', 'spread': '15.66', 'groupId': 'OG000'}]}]}, {'title': 'DBP', 'categories': [{'measurements': [{'value': '3.7', 'spread': '12.98', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)', 'description': 'Blood pressure was measured after the subject had been sitting for at least 3 minutes.', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All-treated data set'}, {'type': 'SECONDARY', 'title': 'Heart Rate: Mean Change From Baseline to Final Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paricalcitol', 'description': 'Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'spread': '17.43', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)', 'description': 'Heart rate was measured after the subject had been sitting for at least 3 minutes.', 'unitOfMeasure': 'bpm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All-treated data set'}, {'type': 'SECONDARY', 'title': 'Oral Body Temperature: Mean Change From Baseline to Final Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paricalcitol', 'description': 'Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.03', 'spread': '0.338', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)', 'unitOfMeasure': 'degrees Celsius', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All-treated data set'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Potentially Clinically Significant Physical Examination Findings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paricalcitol', 'description': 'Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 1) and Final Visit (up to Week 12)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All-treated data set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Paricalcitol', 'description': 'Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Kidney transplant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'A total of 26 subjects were screened and 13 pediatric subjects (between 10 and 16 years of age) were enrolled; 1 subject was 16 years of age at the time of Screening and turned 17 by the time treatment began.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Paricalcitol', 'description': 'Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '14.5', 'spread': '1.76', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'dispFirstSubmitDate': '2016-04-22', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-01', 'studyFirstSubmitDate': '2011-06-24', 'dispFirstSubmitQcDate': '2016-04-22', 'resultsFirstSubmitDate': '2016-09-16', 'studyFirstSubmitQcDate': '2011-06-24', 'dispFirstPostDateStruct': {'date': '2016-05-23', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2018-07-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-11-08', 'studyFirstPostDateStruct': {'date': '2011-06-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Subjects With Hypercalcemia', 'timeFrame': 'Day 1 to Week 12', 'description': 'The percentage of subjects with hypercalcemia, defined as at least 2 consecutive post-baseline corrected calcium values \\> 10.2 mg/dL (2.55 mmol/L).'}], 'secondaryOutcomes': [{'measure': 'Percentage of Subjects With 2 Consecutive Intact Parathyroid Hormone (iPTH)/120 Between 150 and 300 pg/mL', 'timeFrame': 'Baseline (last measurement collected prior to the first dose) to Week 12'}, {'measure': 'Percentage of Subjects With 2 Consecutive iPTH Reductions of at Least 30% From Baseline', 'timeFrame': 'Baseline (last measurement collected prior to the first dose) to Week 12'}, {'measure': 'Hemoglobin: Mean Change From Baseline to Final Visit', 'timeFrame': 'Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)'}, {'measure': 'Hematocrit: Mean Change From Baseline to Final Visit', 'timeFrame': 'Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)'}, {'measure': 'Red Blood Cells: Mean Change From Baseline to Final Visit', 'timeFrame': 'Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)'}, {'measure': 'White Blood Cells (WBC) and Platelet Count: Mean Change From Baseline to Final Visit', 'timeFrame': 'Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)'}, {'measure': 'Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils: Mean Change From Baseline to Final Visit', 'timeFrame': 'Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)'}, {'measure': 'Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactic Dehydrogenase (LDH), and Bone-Specific Alkaline Phosphatase (BSAP): Mean Change From Baseline to Final Visit', 'timeFrame': 'Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)', 'description': 'n=subjects with evaluable Baseline and Post-baseline data for each parameter.'}, {'measure': 'Bilirubin, Blood Urea Nitrogen (BUN), Uric Acid, Magnesium, Glucose, Cholesterol, Triglycerides, High Sensitivity C-Reactive Protein (hsCRP), Inorganic Phosphate, Corrected Calcium, and Creatinine: Mean Change From Baseline to Final Visit', 'timeFrame': 'Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)', 'description': 'n=subjects with evaluable Baseline and Post-baseline data for each parameter.'}, {'measure': 'Alkaline Phosphatase: Mean Change From Baseline to Final Visit', 'timeFrame': 'Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)'}, {'measure': 'Sodium, Potassium, Chloride, Bicarbonate: Mean Change From Baseline to Final Visit', 'timeFrame': 'Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)'}, {'measure': 'Total Protein and Albumin: Mean Change From Baseline to Final Visit', 'timeFrame': 'Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)', 'description': 'n=subjects with evaluable Baseline and Post-baseline data for each parameter.'}, {'measure': 'Fibroblast Growth Factor-23 (FGF-23), 1,25-Hydroxy Vitamin D, 25-Hydroxy Vitamin D, and Intact Parathyroid Hormone (iPTH): Mean Change From Baseline to Final Visit', 'timeFrame': 'Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)', 'description': 'n=subjects with evaluable Baseline and Post-baseline data for each parameter.'}, {'measure': 'Osteocalcin: Mean Change From Baseline to Final Visit', 'timeFrame': 'Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)'}, {'measure': 'Number of Subjects With Adverse Events', 'timeFrame': 'From first dose of study drug until 30 days following last dose of study drug (up to 16 weeks).', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.'}, {'measure': 'Number of Subjects With Potentially Clinically Significant Electrocardiogram (ECG) Findings', 'timeFrame': 'Baseline (Day 1) to Final Visit (up to Week 12)', 'description': '12-lead ECGs were recorded after the subject had been in the supine position for at least 5 minutes. The number of subjects with potentially clinically significant ECG findings, as determined by the investigator, is presented.'}, {'measure': 'Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Mean Change From Baseline to Final Visit', 'timeFrame': 'Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)', 'description': 'Blood pressure was measured after the subject had been sitting for at least 3 minutes.'}, {'measure': 'Heart Rate: Mean Change From Baseline to Final Visit', 'timeFrame': 'Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)', 'description': 'Heart rate was measured after the subject had been sitting for at least 3 minutes.'}, {'measure': 'Oral Body Temperature: Mean Change From Baseline to Final Visit', 'timeFrame': 'Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)'}, {'measure': 'Number of Subjects With Potentially Clinically Significant Physical Examination Findings', 'timeFrame': 'Baseline (Day 1) and Final Visit (up to Week 12)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Evaluate safety through the evaluation of the incidence of hypercalcemia in pediatric subjects'], 'conditions': ['End-Stage Renal Disease', 'Secondary Hyperparathyroidism']}, 'referencesModule': {'references': [{'pmid': '28332096', 'type': 'RESULT', 'citation': 'Webb NJA, Lerner G, Warady BA, Dell KM, Greenbaum LA, Ariceta G, Hoppe B, Linde P, Lee HJ, Eldred A, Dufek MB. Efficacy and safety of paricalcitol in children with stages 3 to 5 chronic kidney disease. Pediatr Nephrol. 2017 Jul;32(7):1221-1232. doi: 10.1007/s00467-017-3579-6. Epub 2017 Mar 22.'}], 'seeAlsoLinks': [{'url': 'http://www.rxabbvie.com', 'label': 'Prescribing Information'}]}, 'descriptionModule': {'briefSummary': 'The objective is to evaluate the safety of paricalcitol capsules in pediatric subjects, ages 10 to 16 years old, with Stage 5 chronic kidney disease (kidney failure) receiving peritoneal dialysis or hemodialysis and being treated for secondary hyperparathyroidism. Subjects will be in the dosing period of the study for 12 weeks in order to evaluate the incidence of hypercalcemia (high calcium levels in blood). Approximately 12 subjects will be enrolled and all 12 will receive paricalcitol capsules.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject must be receiving peritoneal dialysis or hemodialysis for at least 3 months prior to Screening\n* Subject is currently being diagnosed and/or treated for secondary hyperparathyroidism\n* For entry into the Dosing Period (for subjects that are naïve to Vitamin D Receptor \\[VDR\\] Activators or those who have completed a 2 to 12 week washout), the subject must meet the following laboratory criteria prior to enrollment:\n\n * A corrected calcium value ≥ 8.2 and ≤ 10.4 mg/dL\n * A phosphorus value ≤ 6.5 mg/dL\n * An intact parathyroid hormone (iPTH) value \\> 300 pg/mL and less ≤ 2000 pg/mL\n\nExclusion Criteria:\n\n* Subject is expected or scheduled to receive a living donor kidney transplant within 3 months of Screening or is a kidney transplant patient requiring full immunosuppressant therapy\n* Subject is expected to stop peritoneal dialysis or hemodialysis within 4 months of Screening (per investigator discretion)\n* Subject has had a parathyroidectomy within 12 weeks prior to Screening\n* Subject has had symptomatic or significant hypocalcemia requiring VDR Activator therapy (i.e., calcitriol, paricalcitol, or doxercalciferol) within 2 months prior to Screening\n* Subject is taking maintenance calcitonin, bisphosphonates, glucocorticoids in an equivalent dose of greater than 5 mg prednisone daily, or other drugs known to affect calcium or bone metabolism within 4 to 8 weeks prior to Dosing\n* Subject is receiving cinacalcet at the time of Screening'}, 'identificationModule': {'nctId': 'NCT01382212', 'briefTitle': 'A Study to Evaluate the Safety of Paricalcitol Capsules in Pediatric Subjects Ages 10 to 16 With Stage 5 Chronic Kidney Disease Receiving Peritoneal Dialysis or Hemodialysis', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A Phase 3, Open-Label, Multicenter Study to Evaluate the Safety of Paricalcitol Capsules in Pediatric Subjects Ages 10 to 16 With Stage 5 Chronic Kidney Disease Receiving Peritoneal Dialysis or Hemodialysis', 'orgStudyIdInfo': {'id': 'M11-612'}, 'secondaryIdInfos': [{'id': '2013-002610-13', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Paricalcitol', 'description': 'Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.', 'interventionNames': ['Drug: paricalcitol']}], 'interventions': [{'name': 'paricalcitol', 'type': 'DRUG', 'otherNames': ['ABT-358, Zemplar'], 'description': 'Paricalcitol soft capsule. Starting dose of paricalcitol was determined by the intact parathyroid hormone (iPTH) value (iPTH/120) from prior to Day 1, rounded down to the nearest whole number, not to exceed 16 µg 3 times weekly, no more frequently than every other day. Decisions to hold, maintain, increase, or decrease a dose were based on the iPTH, phosphorus, and calcium results generated from the most recent visit and within target Kidney Dialysis Outcomes Quality Initiatives (KDOQI) levels.', 'armGroupLabels': ['Paricalcitol']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Ann Eldred, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie (prior sponsor, Abbott)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}