Ignite Creation Date:
2025-12-24 @ 7:30 PM
Ignite Modification Date:
2025-12-25 @ 5:12 PM
Study NCT ID:
NCT00823303
Status:
COMPLETED
Last Update Posted:
2014-08-07
First Post:
2008-12-12
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Paricalcitol Versus Calcitriol for Efficacy and Safety in Stage 3/4 Chronic Kidney Disease (CKD) With Secondary Hyperparathyroidism (SHPT)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006962', 'term': 'Hyperparathyroidism, Secondary'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D006934', 'term': 'Hypercalcemia'}], 'ancestors': [{'id': 'D006961', 'term': 'Hyperparathyroidism'}, {'id': 'D010279', 'term': 'Parathyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'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': 'D002128', 'term': 'Calcium Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D014883', 'term': 'Water-Electrolyte Imbalance'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C084656', 'term': 'paricalcitol'}, {'id': 'D002117', 'term': 'Calcitriol'}], 'ancestors': [{'id': 'D004100', 'term': 'Dihydroxycholecalciferols'}, {'id': 'D006887', 'term': 'Hydroxycholecalciferols'}, {'id': 'D002762', 'term': 'Cholecalciferol'}, {'id': 'D002782', 'term': 'Cholestenes'}, {'id': 'D002776', 'term': 'Cholestanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013261', 'term': 'Sterols'}, {'id': 'D014807', 'term': 'Vitamin D'}, {'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dcoyne@dom.wustl.edu', 'phone': '3143627211', 'title': 'Dr. Daniel W. Coyne', 'organization': 'Washington University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Paricalcitol', 'description': 'titrated to achieve 40-60% PTH suppression\n\nParicalcitol: 1 mcg daily, adjusted to achieve 40-60% PTH suppression', 'otherNumAtRisk': 53, 'otherNumAffected': 15, 'seriousNumAtRisk': 53, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Calcitriol', 'description': 'titrated to achieve 40-60% PTH suppression\n\nCalcitriol: 0.25 mcg daily, adjusted to achieve 40-60% PTH suppression', 'otherNumAtRisk': 54, 'otherNumAffected': 12, 'seriousNumAtRisk': 54, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Musculoskeletal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Hypercalcemia', 'notes': 'Hypercalcemia requiring or prolonging hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Confirmed Hypercalcemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Paricalcitol', 'description': 'titrated to achieve 40-60% PTH suppression\n\nParicalcitol: 1 mcg daily, adjusted to achieve 40-60% PTH suppression'}, {'id': 'OG001', 'title': 'Calcitriol', 'description': 'titrated to achieve 40-60% PTH suppression\n\nCalcitriol: 0.25 mcg daily, adjusted to achieve 40-60% PTH suppression'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.36', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'On the basis of prior published reports, we estimated a 5% rate of hypercalcemia with paricalcitol and a 30% rate with calcitriol. To have a 90% power to detect a difference at the P=0.05 confidence level, 42 patients per group were needed. Assuming a 30% dropout rate over the course of the study, we planned to randomize 110 patients.'}], 'paramType': 'NUMBER', 'timeFrame': '24 week treatment period', 'description': 'Serum Calcium 10.5 mg/dL or higher, confirmed by repeat measurement.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Paricalcitol', 'description': 'titrated to achieve 40-60% PTH suppression\n\nParicalcitol: 1 mcg daily, adjusted to achieve 40-60% PTH suppression'}, {'id': 'FG001', 'title': 'Calcitriol', 'description': 'titrated to achieve 40-60% PTH suppression\n\nCalcitriol: 0.25 mcg daily, adjusted to achieve 40-60% PTH suppression'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '56'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '45'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '11'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Paricalcitol', 'description': 'titrated to achieve 40-60% PTH suppression\n\nParicalcitol: 1 mcg daily, adjusted to achieve 40-60% PTH suppression'}, {'id': 'BG001', 'title': 'Calcitriol', 'description': 'titrated to achieve 40-60% PTH suppression\n\nCalcitriol: 0.25 mcg daily, adjusted to achieve 40-60% PTH suppression'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.6', 'spread': '13.2', 'groupId': 'BG000'}, {'value': '64.7', 'spread': '12.6', 'groupId': 'BG001'}, {'value': '65.6', 'spread': '12.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Stage 3 and 4 CKD with SHPT, age \\>18, a stable dose of phosphate binder (if receiving a binder), estimated glomerular filtration rate (eGFR) of 15-59 mL/min using the abbreviated MDRD equation, PTH \\>120 pg/mL, albumin-corrected calcium \\>8.5 mg/dL and \\<10.0 mg/dL, phosphorus \\<4.6 mg/dL.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-04', 'studyFirstSubmitDate': '2008-12-12', 'resultsFirstSubmitDate': '2014-06-05', 'studyFirstSubmitQcDate': '2009-01-14', 'lastUpdatePostDateStruct': {'date': '2014-08-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-07-07', 'studyFirstPostDateStruct': {'date': '2009-01-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-08-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Confirmed Hypercalcemia', 'timeFrame': '24 week treatment period', 'description': 'Serum Calcium 10.5 mg/dL or higher, confirmed by repeat measurement.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['PTH', 'Active Vitamin D', 'hypercalcemia', 'Chronic Kidney Disease'], 'conditions': ['Secondary Hyperparathyroidism', 'Chronic Kidney Disease']}, 'referencesModule': {'references': [{'pmid': '24970869', 'type': 'RESULT', 'citation': 'Coyne DW, Goldberg S, Faber M, Ghossein C, Sprague SM. A randomized multicenter trial of paricalcitol versus calcitriol for secondary hyperparathyroidism in stages 3-4 CKD. Clin J Am Soc Nephrol. 2014 Sep 5;9(9):1620-6. doi: 10.2215/CJN.10661013. Epub 2014 Jun 26.'}]}, 'descriptionModule': {'briefSummary': 'Secondary Hyperparathyroidism (SHPT) occurs in many patients with kidney disease and leads to bone disease. Active forms of vitamin D, calcitriol and paricalcitol, treat SHPT, but may have different effects on blood calcium. This study will randomize patients with SHPT and stage 3 or 4 CKD to treatment with calcitriol or paricalcitol, and monitor patients for the incidence of high blood calcium, and effectiveness of SHPT treatment.', 'detailedDescription': 'General Design\n\n* Open label, active comparator, multicenter, parallel group, phase 4 study of paricalcitol versus calcitriol for suppression of PTH in stage 3 and 4 CKD patients with SHPT.\n* Total study duration is 26 weeks (1 week screening, 24 weeks active medications, 1 week follow up.\n* Patients meeting inclusion/exclusion criteria including baseline laboratory results will be randomized to paricalcitol or calcitriol, and enter a 24 weeks treatment phase. Visits, including safety and efficacy laboratory tests will be at weeks 4, 8, 12, 18, and 24. A follow up visit will be performed 1 week after stopping study medication.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n1. Age \\>18; Able to give informed consent\n2. Chronic kidney disease, and estimated GFR 15 to 60 ml/min using the abbreviated MDRD equation\n3. intact PTH (iPTH) \\>120 pg/ml at baseline\n4. albumin corrected calcium \\> 8.5 mg/dL to \\< 10.0 mg/dL at baseline\n5. Phosphorus \\< 4.6 mg/dL at baseline\n6. If on a phosphorus binder; no change in dose within the 4 weeks prior to screening\n\nExclusion Criteria\n\n1. Receiving any active form of vitamin D within 4 weeks prior to screening (calcitriol, doxercalciferol; paricalcitol; alfacalcidol)\n2. Receiving \\>50,000 IU per month of ergocalciferol or \\> 1000 IU of cholecalciferol per day within the previous 30 days.\n3. history of primary HPT\n4. On prednisone \\> 30 days within the previous 6 months\n5. receiving bisphosphonates or calcitonin within the previous 12 months\n6. Non-elective hospitalization within the previous 30 days.\n7. Expected to initiate dialysis or receive a kidney transplant within the next 6 mo.\n8. History of renal or other organ transplant\n9. History of parathyroidectomy or previous diagnosis of primary hyperparathyroidism\n10. Receiving cinacalcet within 4 weeks prior to screening.\n11. An active drug/alcohol dependence or abuse history\n12. History of non-compliance with visits or medications that preclude study compliance in the opinion of the investigator\n13. Pregnant, or able to become pregnant and unwilling to use a birth control method considered reliable by the principal investigator'}, 'identificationModule': {'nctId': 'NCT00823303', 'acronym': 'PACE', 'briefTitle': 'Paricalcitol Versus Calcitriol for Efficacy and Safety in Stage 3/4 Chronic Kidney Disease (CKD) With Secondary Hyperparathyroidism (SHPT)', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'A Phase 4 Randomized Multicenter Open Label Trial of Paricalcitol Versus Calcitriol for Efficacy and Safety in Stage 3 or 4 Ckd Patients With Secondary Hyperparathyroidism', 'orgStudyIdInfo': {'id': '22095'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Paricalcitol', 'description': 'titrated to achieve 40-60% PTH suppression', 'interventionNames': ['Drug: Paricalcitol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Calcitriol', 'description': 'titrated to achieve 40-60% PTH suppression', 'interventionNames': ['Drug: Calcitriol']}], 'interventions': [{'name': 'Paricalcitol', 'type': 'DRUG', 'otherNames': ['Zemplar'], 'description': '1 mcg daily, adjusted to achieve 40-60% PTH suppression', 'armGroupLabels': ['Paricalcitol']}, {'name': 'Calcitriol', 'type': 'DRUG', 'otherNames': ['Rocaltrol'], 'description': '0.25 mcg daily, adjusted to achieve 40-60% PTH suppression', 'armGroupLabels': ['Calcitriol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60201', 'city': 'Evanston', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northshore University Health System', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Hospital', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Daniel W Coyne, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Henry Ford Hospital', 'class': 'OTHER'}, {'name': 'Northwestern University Feinberg School of Medicine', 'class': 'OTHER'}, {'name': 'Endeavor Health', 'class': 'OTHER'}, {'name': 'Abbott', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Daniel W. Coyne', 'investigatorAffiliation': 'Washington University School of Medicine'}}}}