Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2025-12-25 @ 2:35 PM
Study NCT ID:
NCT02937350
Status:
COMPLETED
Last Update Posted:
2021-09-01
First Post:
2016-10-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Clearance of 25-hydroxyvitamin D in Chronic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'IDeBoer@Nephrology.washington.edu', 'phone': '206-616-5403', 'title': 'Dr. Ian de Boer', 'organization': 'University of Washington'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '8 weeks', 'description': 'Everyone had the same treatment, so it was more appropriate to summarize AEs for the whole group. Adverse events were not collected separately per arm.', 'eventGroups': [{'id': 'EG000', 'title': 'All Participants', 'description': 'All participants (N=87)', 'otherNumAtRisk': 87, 'deathsNumAtRisk': 87, 'otherNumAffected': 16, 'seriousNumAtRisk': 87, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Pain or sensation in arm during infusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Metabolic Clearance of D6-25(OH)D3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Controls', 'description': 'Healthy controls defined as normal eGFR (\\>60 ml/min per 1.73m2)'}, {'id': 'OG001', 'title': 'CKD Group', 'description': 'CKD group defined as those with eGFR \\<60ml/min per 1.73 m2)'}, {'id': 'OG002', 'title': 'Kidney Failure Group', 'description': 'Kidney failure group defined as those with ESKD treated with dialysis'}], 'classes': [{'categories': [{'measurements': [{'value': '360', 'spread': '108', 'groupId': 'OG000'}, {'value': '313', 'spread': '86', 'groupId': 'OG001'}, {'value': '263', 'spread': '163', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'Metabolic clearance is calculated as the administered dose of 25(OH)D3 divided by the area under the plasma concentration-time curve (AUC). AUC is calculated using the linear trapezoidal method. Concentration was measured at 5 minutes, 4 hours, and at 1, 4, 7, 14, 21, 28, 42, and 56 days post administration.', 'unitOfMeasure': 'milliliter per day (ml/d)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'AUC of D6-25(OH)D3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Controls', 'description': 'Healthy controls defined as normal eGFR (\\>60 ml/min per 1.73m2)'}, {'id': 'OG001', 'title': 'CKD Group', 'description': 'CKD group defined as those with eGFR \\<60ml/min per 1.73 m2)'}, {'id': 'OG002', 'title': 'Kidney Failure Group', 'description': 'Kidney failure group defined as those with ESKD treated with dialysis'}], 'classes': [{'categories': [{'measurements': [{'value': '59.8', 'spread': '10.2', 'groupId': 'OG000'}, {'value': '68.7', 'spread': '10.2', 'groupId': 'OG001'}, {'value': '76.6', 'spread': '12.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'AUC is calculated using the linear trapezoidal method. Concentration was measured at 5 minutes, 4 hours, and at 1, 4, 7, 14, 21, 28, 42, and 56 days post administration.', 'unitOfMeasure': 'nanograms x day/mL (ngxd/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Terminal Half-life of D6-25(OH)D3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Controls', 'description': 'Healthy controls defined as normal eGFR (\\>60 ml/min per 1.73m2)'}, {'id': 'OG001', 'title': 'CKD Group', 'description': 'CKD group defined as those with eGFR \\<60ml/min per 1.73 m2)'}, {'id': 'OG002', 'title': 'Kidney Failure Group', 'description': 'Kidney failure group defined as those with ESKD treated with dialysis'}], 'classes': [{'categories': [{'measurements': [{'value': '21.9', 'spread': '5.7', 'groupId': 'OG000'}, {'value': '25.5', 'spread': '6.5', 'groupId': 'OG001'}, {'value': '35.6', 'spread': '8.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'Terminal half-life is equal to ln2/k, where k is the slope of the terminal regression line estimated using ≥3 plasma concentrations. Concentration was measured at 5 minutes, 4 hours, and at 1, 4, 7, 14, 21, 28, 42, and 56 days post administration.', 'unitOfMeasure': 'days (d)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Volume of Distribution of D6-25(OH)D3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Controls', 'description': 'Healthy controls defined as normal eGFR (\\>60 ml/min per 1.73m2)'}, {'id': 'OG001', 'title': 'CKD Group', 'description': 'CKD group defined as those with eGFR \\<60ml/min per 1.73 m2)'}, {'id': 'OG002', 'title': 'Kidney Failure Group', 'description': 'Kidney failure group defined as those with ESKD treated with dialysis'}], 'classes': [{'categories': [{'measurements': [{'value': '11.0', 'spread': '2.9', 'groupId': 'OG000'}, {'value': '11.1', 'spread': '2.8', 'groupId': 'OG001'}, {'value': '12.5', 'spread': '4.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'Volume of distribution in the central compartment is calculated as dose/C0, where dose is the administered dose of 25(OH)D3 and C0 is the initial (estimated) concentration of drug in plasma. Concentration was measured at 5 minutes, 4 hours, and at 1, 4, 7, 14, 21, 28, 42, and 56 days post administration.', 'unitOfMeasure': 'Liters (L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Metabolic Formation Clearance of D6-25(OH)D3 Metabolites.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Controls', 'description': 'Healthy controls defined as normal eGFR (\\>60 ml/min per 1.73m2)'}, {'id': 'OG001', 'title': 'CKD Group', 'description': 'CKD group defined as those with eGFR \\<60ml/min per 1.73 m2)'}, {'id': 'OG002', 'title': 'Kidney Failure Group', 'description': 'Kidney failure group defined as those with ESKD treated with dialysis'}], 'classes': [{'categories': [{'measurements': [{'value': '0.12', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '0.08', 'spread': '0.03', 'groupId': 'OG001'}, {'value': '0.03', 'spread': '0.03', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'Metabolic formation clearance is calculated as the daughter metabolite plasma AUC divided by the AUC of D6-25(OH)D3 (metabolite/parent AUC ratio). AUC is calculated using the linear trapezoidal method. Concentration was measured at 5 minutes, 4 hours, and at 1, 4, 7, 14, 21, 28, 42, and 56 days post administration.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in the Serum Concentration of Calcium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Controls', 'description': 'Healthy controls defined as normal eGFR (\\>60 ml/min per 1.73m2)'}, {'id': 'OG001', 'title': 'CKD Group', 'description': 'CKD group defined as those with eGFR \\<60ml/min per 1.73 m2)'}, {'id': 'OG002', 'title': 'Kidney Failure Group', 'description': 'Kidney failure group defined as those with ESKD treated with dialysis'}], 'classes': [{'categories': [{'measurements': [{'value': '0.42', 'spread': '1.75', 'groupId': 'OG000'}, {'value': '0.16', 'spread': '0.26', 'groupId': 'OG001'}, {'value': '-0.27', 'spread': '0.48', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7 days', 'description': 'Change in the serum concentration of calcium from baseline to 7 days after 25(OH)D3 administration', 'unitOfMeasure': 'milligrams/deciliter (mg/dl)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in the Serum Concentration of Creatinine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Controls', 'description': 'Healthy controls defined as normal eGFR (\\>60 ml/min per 1.73m2)'}, {'id': 'OG001', 'title': 'CKD Group', 'description': 'CKD group defined as those with eGFR \\<60ml/min per 1.73 m2)'}, {'id': 'OG002', 'title': 'Kidney Failure Group', 'description': 'Kidney failure group defined as those with ESKD treated with dialysis'}], 'classes': [{'categories': [{'measurements': [{'value': '0.04', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '-0.05', 'spread': '0.27', 'groupId': 'OG001'}, {'value': '2.81', 'spread': '2.26', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 7 days', 'description': 'Change in the serum concentration of creatinine from baseline to 7 days after 25(OH)D3 administration', 'unitOfMeasure': 'milligrams/deciliter (mg/dl)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in the Serum Concentration of AST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Controls', 'description': 'Healthy controls defined as normal eGFR (\\>60 ml/min per 1.73m2)'}, {'id': 'OG001', 'title': 'CKD Group', 'description': 'CKD group defined as those with eGFR \\<60ml/min per 1.73 m2)'}, {'id': 'OG002', 'title': 'Kidney Failure Group', 'description': 'Kidney failure group defined as those with ESKD treated with dialysis'}], 'classes': [{'categories': [{'measurements': [{'value': '0.40', 'spread': '3.43', 'groupId': 'OG000'}, {'value': '0.57', 'spread': '5.98', 'groupId': 'OG001'}, {'value': '0.10', 'spread': '5.22', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 7 days', 'description': 'Change in the serum concentration of AST from baseline to 7 days after 25(OH)D3 administration', 'unitOfMeasure': 'units/Liter (u/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in the Serum Concentration of ALT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Controls', 'description': 'Healthy controls defined as normal eGFR (\\>60 ml/min per 1.73m2)'}, {'id': 'OG001', 'title': 'CKD Group', 'description': 'CKD group defined as those with eGFR \\<60ml/min per 1.73 m2)'}, {'id': 'OG002', 'title': 'Kidney Failure Group', 'description': 'Kidney failure group defined as those with ESKD treated with dialysis'}], 'classes': [{'categories': [{'measurements': [{'value': '0.16', 'spread': '3.71', 'groupId': 'OG000'}, {'value': '1.52', 'spread': '6.92', 'groupId': 'OG001'}, {'value': '0.45', 'spread': '3.66', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 7 days', 'description': 'Change in the serum concentration of ALT from baseline to 7 days after 25(OH)D3 administration', 'unitOfMeasure': 'units/Liter (u/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Healthy Controls', 'description': 'Healthy controls defined as normal eGFR (\\>60 ml/min per 1.73m2)'}, {'id': 'FG001', 'title': 'CKD Group', 'description': 'CKD group defined as those with eGFR \\<60ml/min per 1.73 m2)'}, {'id': 'FG002', 'title': 'Kidney Failure Group', 'description': 'Kidney failure group defined as those with ESKD treated with dialysis'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '87', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Healthy Controls', 'description': 'Healthy controls defined as normal eGFR (\\>60 ml/min per 1.73m2)'}, {'id': 'BG001', 'title': 'CKD Group', 'description': 'CKD group defined as those with eGFR \\<60ml/min per 1.73 m2)'}, {'id': 'BG002', 'title': 'Kidney Failure Group', 'description': 'Kidney failure group defined as those with ESKD treated with dialysis'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64', 'spread': '10', 'groupId': 'BG000'}, {'value': '67', 'spread': '11', 'groupId': 'BG001'}, {'value': '58', 'spread': '9', 'groupId': 'BG002'}, {'value': '64', 'spread': '11', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'title': 'Race', 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '61', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Vitamin-D3 Supplement Use', 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-02-10', 'size': 552126, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-05-12T16:01', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-31', 'studyFirstSubmitDate': '2016-10-14', 'resultsFirstSubmitDate': '2021-05-30', 'studyFirstSubmitQcDate': '2016-10-14', 'lastUpdatePostDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-08-31', 'studyFirstPostDateStruct': {'date': '2016-10-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Metabolic Formation Clearance of D6-25(OH)D3 Metabolites.', 'timeFrame': '8 weeks', 'description': 'Metabolic formation clearance is calculated as the daughter metabolite plasma AUC divided by the AUC of D6-25(OH)D3 (metabolite/parent AUC ratio). AUC is calculated using the linear trapezoidal method. Concentration was measured at 5 minutes, 4 hours, and at 1, 4, 7, 14, 21, 28, 42, and 56 days post administration.'}, {'measure': 'Change in the Serum Concentration of Calcium', 'timeFrame': '7 days', 'description': 'Change in the serum concentration of calcium from baseline to 7 days after 25(OH)D3 administration'}, {'measure': 'Change in the Serum Concentration of Creatinine', 'timeFrame': 'Baseline, 7 days', 'description': 'Change in the serum concentration of creatinine from baseline to 7 days after 25(OH)D3 administration'}, {'measure': 'Change in the Serum Concentration of AST', 'timeFrame': 'Baseline, 7 days', 'description': 'Change in the serum concentration of AST from baseline to 7 days after 25(OH)D3 administration'}, {'measure': 'Change in the Serum Concentration of ALT', 'timeFrame': 'Baseline, 7 days', 'description': 'Change in the serum concentration of ALT from baseline to 7 days after 25(OH)D3 administration'}], 'primaryOutcomes': [{'measure': 'Metabolic Clearance of D6-25(OH)D3', 'timeFrame': '8 weeks', 'description': 'Metabolic clearance is calculated as the administered dose of 25(OH)D3 divided by the area under the plasma concentration-time curve (AUC). AUC is calculated using the linear trapezoidal method. Concentration was measured at 5 minutes, 4 hours, and at 1, 4, 7, 14, 21, 28, 42, and 56 days post administration.'}], 'secondaryOutcomes': [{'measure': 'AUC of D6-25(OH)D3', 'timeFrame': '8 weeks', 'description': 'AUC is calculated using the linear trapezoidal method. Concentration was measured at 5 minutes, 4 hours, and at 1, 4, 7, 14, 21, 28, 42, and 56 days post administration.'}, {'measure': 'Terminal Half-life of D6-25(OH)D3', 'timeFrame': '8 weeks', 'description': 'Terminal half-life is equal to ln2/k, where k is the slope of the terminal regression line estimated using ≥3 plasma concentrations. Concentration was measured at 5 minutes, 4 hours, and at 1, 4, 7, 14, 21, 28, 42, and 56 days post administration.'}, {'measure': 'Volume of Distribution of D6-25(OH)D3', 'timeFrame': '8 weeks', 'description': 'Volume of distribution in the central compartment is calculated as dose/C0, where dose is the administered dose of 25(OH)D3 and C0 is the initial (estimated) concentration of drug in plasma. Concentration was measured at 5 minutes, 4 hours, and at 1, 4, 7, 14, 21, 28, 42, and 56 days post administration.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['chronic kidney disease', 'vitamin d catabolism'], 'conditions': ['Chronic Kidney Disease']}, 'referencesModule': {'references': [{'pmid': '36404469', 'type': 'DERIVED', 'citation': 'Best CM, Thummel KE, Hsu S, Lin Y, Zelnick LR, Kestenbaum B, Kushnir MM, de Boer IH, Hoofnagle AN. The plasma free fraction of 25-hydroxyvitamin D3 is not strongly associated with 25-hydroxyvitamin D3 clearance in kidney disease patients and controls. J Steroid Biochem Mol Biol. 2023 Feb;226:106206. doi: 10.1016/j.jsbmb.2022.106206. Epub 2022 Oct 28.'}, {'pmid': '33115916', 'type': 'DERIVED', 'citation': 'Hsu S, Zelnick LR, Lin YS, Best CM, Kestenbaum B, Thummel KE, Rose LM, Hoofnagle AN, de Boer IH. Differences in 25-Hydroxyvitamin D Clearance by eGFR and Race: A Pharmacokinetic Study. J Am Soc Nephrol. 2021 Jan;32(1):188-198. doi: 10.1681/ASN.2020050625. Epub 2020 Oct 28.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to better understand vitamin D catabolism and how it is affected by CKD and race.', 'detailedDescription': 'Specifically, the study team will evaluate the metabolic clearance of 25-hydroxyvitamin D3 in individuals with varying degrees of CKD and among participants who self-report race as Caucasian, African American or African. The long-term goal of this work is to enhance the clinical evaluation and treatment of impaired vitamin D metabolism.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Self-reported race Caucasian, African American, or African\n* Serum total 25(OH)D 10-50 ng/mL\n* Estimated GFR:\n\n * 60 mL/min/1.73m2 (N=40) 15-45 mL/min/1.73m2 (N=40) \\<15 mL/min/1.73m2, treated with hemodialysis (N=40)\n\nExclusion Criteria:\n\n* Primary hyperparathyroidism\n* Gastric bypass\n* Tuberculosis or sarcoidosis\n* Current pregnancy\n* Child-Pugh Class B or C cirrhosis (i.e. cirrhosis with ascites, hepatic encephalopathy, bilirubin \\>=2 mg/dL, serum albumin \\<=3.5 g/dL, or PT \\>= 4 seconds)\n* Use of vitamin D3, or vitamin D2 supplements exceeding a mean daily dose of 400 IU, within 3 months (wash-out allowed)\n* Use of 1,25(OH)2D3 or an analogue, calcimimetics, or medications known to induce CYP24A1 within 4 weeks (wash-out allowed)\n* Serum calcium \\> 10.1 mg/dL\n* Hemoglobin \\< 10 g/dL'}, 'identificationModule': {'nctId': 'NCT02937350', 'acronym': 'CLEAR', 'briefTitle': 'Clearance of 25-hydroxyvitamin D in Chronic Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Clearance of 25-hydroxyvitamin D in Chronic Kidney Disease', 'orgStudyIdInfo': {'id': 'STUDY00009578'}, 'secondaryIdInfos': [{'id': 'R01DK099199', 'link': 'https://reporter.nih.gov/quickSearch/R01DK099199', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study Population', 'description': 'D6-25-hydroxyvitamin D3', 'interventionNames': ['Drug: D6-25-hydroxyvitamin D3']}], 'interventions': [{'name': 'D6-25-hydroxyvitamin D3', 'type': 'DRUG', 'otherNames': ['stable isotope deuterium-labeled 25(OH)D3'], 'description': 'Intravenous administration of a deuterium-labeled 25(OH)D3 to evaluate the metabolic clearance of 25(OH)D3', 'armGroupLabels': ['Study Population']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Ian de Boer, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Medicine/Nephrology', 'investigatorFullName': 'Ian deBoer', 'investigatorAffiliation': 'University of Washington'}}}}