Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-31 @ 3:46 AM
Study NCT ID:
NCT00421733
Status:
COMPLETED
Last Update Posted:
2012-01-20
First Post:
2007-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Effect of Paricalcitol Capsules on Reducing Albuminuria in Patients With Type 2 Diabetic Nephropathy Being Treated With Renin-angiotensin System Inhibitors
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003928', 'term': 'Diabetic Nephropathies'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'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': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C084656', 'term': 'paricalcitol'}, {'id': 'D002214', 'term': 'Capsules'}], 'ancestors': [{'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, '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': {'timeFrame': 'up to 24 weeks', 'description': 'Treatment-emergent serious adverse and non-serious adverse events were reported after the first dose of study drug through 30 days after the last dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Paricalcitol 1 Mcg', 'description': 'One paricalcitol 1 mcg capsule and one matching placebo capsule per dose', 'otherNumAtRisk': 93, 'otherNumAffected': 38, 'seriousNumAtRisk': 93, 'seriousNumAffected': 13}, {'id': 'EG001', 'title': 'Paricalcitol 2 Mcg', 'description': 'Two paricalcitol 1 mcg capsules per dose', 'otherNumAtRisk': 95, 'otherNumAffected': 46, 'seriousNumAtRisk': 95, 'seriousNumAffected': 19}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Two placebo capsules per dose', 'otherNumAtRisk': 93, 'otherNumAffected': 46, 'seriousNumAtRisk': 93, 'seriousNumAffected': 12}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Tinea pedis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Blood parathyroid hormone decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Chronic obstructive pulmonsry disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 11}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Intracardiac thrombus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gastrointestinal angiodysplasia haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Retinal oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Duodenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Impaired healing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Posteroperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Diabetes mellitus inadequate control', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Fluid overload', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Benign colonic neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Oesophageal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Nervousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Substance abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Renal failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dyspnoea exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Extremity necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline to the Last On-treatment Measurement in Urine Albumin to Creatinine Ratio (UACR) Levels Determined From the First Morning Void (FMV) Urine Collections Comparing Placebo to the Combined Paricalcitol Treatment Groups (1 Mcg and 2 Mcg).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}, {'value': '92', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Two placebo capsules per dose (N=88)'}, {'id': 'OG001', 'title': 'Combined Paricalcitol 1 Mcg and 2 Mcg', 'description': 'Combined participants in the 1 mcg and 2 mcg paricalcitol groups (N=92+92=184).'}, {'id': 'OG002', 'title': 'Paricalcitol 1 Mcg', 'description': 'One paricalcitol 1 mcg capsule and one matching placebo capsule per dose'}, {'id': 'OG003', 'title': 'Paricalcitol 2 Mcg', 'description': 'Two paricalcitol 1 mcg capsules per dose'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '-0.18', 'spread': '0.70', 'groupId': 'OG001'}, {'value': '-0.15', 'spread': '0.72', 'groupId': 'OG002'}, {'value': '-0.22', 'spread': '0.69', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.071', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'There were no P-value adjustments for multiple comparisons.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': '1-way ANCOVA using treatment group as the factor and baseline FMV UACR as the covariate.', 'testedNonInferiority': False}, {'pValue': '0.229', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'There were no P-value adjustments for multiple comparisons.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': '1-way ANCOVA with treatment group as the factor and baseline FMV UACR as the covariate.', 'testedNonInferiority': False}, {'pValue': '0.053', 'groupIds': ['OG000', 'OG003'], 'ciPctValue': '95', 'pValueComment': 'There were no P-value adjustments for multiple comparisons.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': '1-way ANCOVA using treatment group as the factor and baseline FMV UACR as the covariate.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (within 1 week prior to first treatment) through 24 weeks of treatment', 'description': 'UACR is defined as the ratio: milligram of albumin per gram of creatinine. Baseline UACR was determined as the mean of the 3 UACR measurements from FMV urine collections obtained within 1 week prior to the day of the first dose of study drug. The last on-treatment measurement was the mean of the 3 UACR measurements obtained from FMV urine collections obtained within 1 week of the final week of treatment. The UACR data were log transformed prior to analysis.', 'unitOfMeasure': 'log milligram/gram creatinine', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population, which was all randomized participants who received at least 1 dose of study drug. Subjects without both a baseline and last on-treatment measurement were excluded from the primary efficacy analysis. As such, sample size was N=88 for placebo, N=92 for 1 mcg and for 2 mcg paricalcitol, and N=184 for combined paricalcitol.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving a 15% or Greater Reduction From Baseline to Last On-treatment Urine Albumin to Creatinine Ratio (UACR) Levels.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Paricalcitol 1 Mcg', 'description': 'One paricalcitol 1 mcg capsule and one matching placebo capsule per dose'}, {'id': 'OG001', 'title': 'Paricalcitol 2 Mcg', 'description': 'Two paricalcitol 1 mcg capsules per dose'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Two placebo capsules per dose'}], 'classes': [{'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.102', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.038', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (within 1 week prior to first treatment) through 24 weeks of treatment', 'description': 'Number of participants whose last on-treatment albumin to creatinine ratio (UACR) value was reduced at least 15% from the baseline value. Albumin values were determined from 24-hour urine collections from the baseline and last on-treatment visits.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population, which was all randomized subjects who received at least one dose of study drug. Subjects who did not have both a baseline measurement and a last on-treatment visit value were excluded from the analyses.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to the Last On-treatment Measurement in Albumin Levels Determined From 24-hour Urine Collection.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Paricalcitol 1 Mcg', 'description': 'One paricalcitol 1 mcg capsule and one matching placebo capsule per dose'}, {'id': 'OG001', 'title': 'Paricalcitol 2 Mcg', 'description': 'Two paricalcitol 1 mcg capsules per dose'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Two placebo capsules per dose'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.10', 'spread': '0.73', 'groupId': 'OG000'}, {'value': '-0.44', 'spread': '0.90', 'groupId': 'OG001'}, {'value': '-0.08', 'spread': '0.73', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.855', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.02', 'ciLowerLimit': '-0.26', 'ciUpperLimit': '0.22', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': '2-way ANCOVA: baseline UACR as covariate; fixed factors for treatment group, stratification level, and treatment by stratification level interaction', 'testedNonInferiority': False}, {'pValue': '0.009', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.33', 'ciLowerLimit': '-0.57', 'ciUpperLimit': '-0.08', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': '2-way ANCOVA: baseline UACR as covariate; fixed factors for treatment group, stratification level, and treatment by stratification level interaction', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (within 1 week prior to first treatment) through 24 weeks of treatment', 'description': 'The change is mean change from baseline to the last on-treatment value, with the data being log transformed prior to analysis. Albumin values were determined from 24-hour urine collections from the baseline and last on-treatment visits.', 'unitOfMeasure': 'log milligrams of albumin per 24 hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population, which was all randomized subjects who received at least one dose of study drug. Subjects who did not have both a baseline measurement and a last on-treatment visit value were excluded from the analyses.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to the Last On-treatment Observation in Intact Parathyroid Hormone (iPTH) Levels.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Paricalcitol 1 Mcg', 'description': 'One paricalcitol 1 mcg capsule and one matching placebo capsule per dose'}, {'id': 'OG001', 'title': 'Paricalcitol 2 Mcg', 'description': 'Two paricalcitol 1 mcg capsules per dose'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Two placebo capsules per dose'}], 'classes': [{'categories': [{'measurements': [{'value': '-26.7', 'spread': '55.2', 'groupId': 'OG000'}, {'value': '-50.7', 'spread': '63.1', 'groupId': 'OG001'}, {'value': '18.3', 'spread': '55.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': '1-way ANCOVA with treatment group as the factor and baseline iPTH as covariate.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': '1-way ANCOVA with treatment group as the factor and baseline iPTH as covariate.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (screening period) through 24 weeks of treatment', 'description': 'Change is mean change in picograms of iPTH per milliliter of serum.', 'unitOfMeasure': 'picogram/milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population, which was all randomized subjects who received at least one dose of study drug. Subjects who did not have both a baseline and a last on-treatment measurement were excluded from the analyses.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Paricalcitol 1 Mcg', 'description': 'One paricalcitol 1 mcg capsule and one matching placebo capsule per dose'}, {'id': 'FG001', 'title': 'Paricalcitol 2 Mcg', 'description': 'Two paricalcitol 1 mcg capsules per dose'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Two placebo capsules per dose'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '93'}, {'groupId': 'FG001', 'numSubjects': '95'}, {'groupId': 'FG002', 'numSubjects': '93'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '78'}, {'groupId': 'FG001', 'numSubjects': '69'}, {'groupId': 'FG002', 'numSubjects': '73'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '20'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Required dialysis', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Administrative', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Did not satisfy entry criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Sponsor request', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Protocol deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}, {'value': '281', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Paricalcitol 1 Mcg', 'description': 'One paricalcitol 1 mcg capsule and one matching placebo capsule per dose'}, {'id': 'BG001', 'title': 'Paricalcitol 2 Mcg', 'description': 'Two paricalcitol 1 mcg capsules per dose'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Two placebo capsules per dose'}, {'id': 'BG003', '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'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '136', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '145', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.0', 'spread': '10.15', 'groupId': 'BG000'}, {'value': '64.7', 'spread': '9.92', 'groupId': 'BG001'}, {'value': '64.5', 'spread': '11.23', 'groupId': 'BG002'}, {'value': '64.4', 'spread': '10.41', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '86', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '195', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Portugal', 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'BG003'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 281}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-18', 'studyFirstSubmitDate': '2007-01-10', 'resultsFirstSubmitDate': '2010-06-09', 'studyFirstSubmitQcDate': '2007-01-11', 'lastUpdatePostDateStruct': {'date': '2012-01-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-08-20', 'studyFirstPostDateStruct': {'date': '2007-01-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-09-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline to the Last On-treatment Measurement in Urine Albumin to Creatinine Ratio (UACR) Levels Determined From the First Morning Void (FMV) Urine Collections Comparing Placebo to the Combined Paricalcitol Treatment Groups (1 Mcg and 2 Mcg).', 'timeFrame': 'Baseline (within 1 week prior to first treatment) through 24 weeks of treatment', 'description': 'UACR is defined as the ratio: milligram of albumin per gram of creatinine. Baseline UACR was determined as the mean of the 3 UACR measurements from FMV urine collections obtained within 1 week prior to the day of the first dose of study drug. The last on-treatment measurement was the mean of the 3 UACR measurements obtained from FMV urine collections obtained within 1 week of the final week of treatment. The UACR data were log transformed prior to analysis.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Achieving a 15% or Greater Reduction From Baseline to Last On-treatment Urine Albumin to Creatinine Ratio (UACR) Levels.', 'timeFrame': 'Baseline (within 1 week prior to first treatment) through 24 weeks of treatment', 'description': 'Number of participants whose last on-treatment albumin to creatinine ratio (UACR) value was reduced at least 15% from the baseline value. Albumin values were determined from 24-hour urine collections from the baseline and last on-treatment visits.'}, {'measure': 'Change From Baseline to the Last On-treatment Measurement in Albumin Levels Determined From 24-hour Urine Collection.', 'timeFrame': 'Baseline (within 1 week prior to first treatment) through 24 weeks of treatment', 'description': 'The change is mean change from baseline to the last on-treatment value, with the data being log transformed prior to analysis. Albumin values were determined from 24-hour urine collections from the baseline and last on-treatment visits.'}, {'measure': 'Change From Baseline to the Last On-treatment Observation in Intact Parathyroid Hormone (iPTH) Levels.', 'timeFrame': 'Baseline (screening period) through 24 weeks of treatment', 'description': 'Change is mean change in picograms of iPTH per milliliter of serum.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Type 2 Diabetic Nephropathy'], 'conditions': ['Diabetic Nephropathy', 'Chronic Kidney Disease']}, 'referencesModule': {'references': [{'pmid': '23787544', 'type': 'DERIVED', 'citation': 'Coyne DW, Andress DL, Amdahl MJ, Ritz E, de Zeeuw D. Effects of paricalcitol on calcium and phosphate metabolism and markers of bone health in patients with diabetic nephropathy: results of the VITAL study. Nephrol Dial Transplant. 2013 Sep;28(9):2260-8. doi: 10.1093/ndt/gft227. Epub 2013 Jun 19.'}, {'pmid': '21055801', 'type': 'DERIVED', 'citation': 'de Zeeuw D, Agarwal R, Amdahl M, Audhya P, Coyne D, Garimella T, Parving HH, Pritchett Y, Remuzzi G, Ritz E, Andress D. Selective vitamin D receptor activation with paricalcitol for reduction of albuminuria in patients with type 2 diabetes (VITAL study): a randomised controlled trial. Lancet. 2010 Nov 6;376(9752):1543-51. doi: 10.1016/S0140-6736(10)61032-X.'}]}, 'descriptionModule': {'briefSummary': 'The study objective was to evaluate the safety of paricalcitol capsules and the efficacy of paricalcitol capsules for albuminuria reduction in patients with Chronic Kidney Disease (CKD) who have Type 2 diabetic nephropathy and are receiving optimal angiotensin converting enzyme (ACE) inhibitor and/or angiotensin II receptor blocker (ARB) therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female participant \\>= 20 years old.\n* Participant has Type 2 Diabetes Mellitus and has been treated with at least one anti-hyperglycemic medication within the 12 months prior to the Screening Phase\n* Participant has been receiving a stable dose (i.e., same type and regimen) of ACEi and/or ARB for at least three months prior to the Screening Phase. However, participant may have switched to different brands but at equivalent doses during the three months prior to the Screening Phase.\n* Participant is not expected to begin dialysis for at least 6 months.\n* If female, participant is not breast feeding or is not pregnant.\n* For entry into the Treatment Phase, the participant must satisfy the following criteria based on the Screening laboratory values:\n\n * Estimated glomerular filtration rate (GFR) between 15-90 mL/min/1.73m2 by simplified Modification in Diet in Renal Disease (MDRD) formula\n * Urinary albumin to creatinine ratio (UACR) between 100 and 3000 mg/g as determined by the mean of the three first morning void urine specimens obtained within one week of each other\n * Corrected serum calcium level \\<= 9.8 mg/dL\n * intact parathyroid hormone (iPTH) value between 35-500 pg/mL\n * Glycosylated hemoglobin A1c (HbA1c) \\<= 12%\n * Serum albumin \\> 3.0 g/dL\n * Negative urine pregnancy test for female participants\n\nExclusion Criteria:\n\n* Participant has previously been on prescription-based vitamin D therapy within the six months prior to the Screening Phase.\n* Participant has a history of an allergic reaction or significant sensitivity to paricalcitol or to drugs similar to the study drug.\n* Participant has primary glomerulonephritis or secondary nephritis in addition to diabetic nephropathy.\n* Participant has had acute renal failure within 12 weeks of the Screening Phase, defined as an acute rise (of \\>= 0.5 mg/dL) in serum creatinine to \\> 4 mg/dL.\n* Participant has chronic gastrointestinal disease.\n* Participant has secondary hypertension.\n* Participant has poorly controlled hypertension.\n* Participant has a history of kidney stones.\n* Participant has a history of drug or alcohol abuse within six months prior to the Screening Phase.\n* Participant has evidence of poor compliance with diet or medication.\n* Participant has received any investigational drug within 30 days prior to study drug administration.\n* Participant is taking calcitonin, bisphosphonates, cinacalcet, glucocorticoids (except topical glucocorticoids), or other drugs that may affect calcium, or bone metabolism, other than calcium containing phosphate binder or female participants on stable (same dose and product for three months) estrogen and/or progestin therapy.\n* For any reason, participant is considered by the Investigator to be an unsuitable candidate to receive paricalcitol capsules or is put at risk by study procedures.\n* Participant is known to be human immunodeficiency virus (HIV) positive.\n* Participant has used known inhibitors or inducers of cytochrome P450 3A (CYP3A) within two weeks prior to study drug administration.'}, 'identificationModule': {'nctId': 'NCT00421733', 'acronym': 'VITAL', 'briefTitle': 'The Effect of Paricalcitol Capsules on Reducing Albuminuria in Patients With Type 2 Diabetic Nephropathy Being Treated With Renin-angiotensin System Inhibitors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott'}, 'officialTitle': 'VITAL Study - Selective VITamin D Receptor Activator (Paricalcitol) for Albuminuria Lowering Study: A Phase 2, Prospective, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Paricalcitol Capsules on Reducing Albuminuria in Type 2 Diabetic Nephropathy Subjects Who Are Currently Being Treated With Renin-angiotensin System Inhibitors', 'orgStudyIdInfo': {'id': 'M05-741'}, 'secondaryIdInfos': [{'id': '2006-001363-31', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Paricalcitol 1 mcg', 'description': 'One paricalcitol 1 mcg capsule and one matching placebo capsule per dose', 'interventionNames': ['Drug: Zemplar (paricalcitol ) capsules']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Paricalcitol 2 mcg', 'description': 'Two paricalcitol 1 mcg capsules per dose', 'interventionNames': ['Drug: Zemplar 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