Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2026-03-05 @ 12:22 PM
Study NCT ID:
NCT03136705
Status:
COMPLETED
Last Update Posted:
2024-02-23
First Post:
2017-03-23
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Healthy Combine Study
Sponsor:
Organization:
Raw JSON
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'otherNumAffected': 1, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Lanthanum Placebo + Nicotinamide', 'description': 'Lanthanum Carbonate Placebo orally three times daily with meals for 2 weeks and Nicotinamide 750mg orally twice daily for 2 weeks\n\nNicotinamide: Nicotinamide tablet\n\nLanthanum Carbonate Placebo: Sugar pill manufactured to look like Lanthanum Carbonate tablet', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Lanthanum Placebo + Nicotinamide Placebo', 'description': 'Lanthanum Carbonate Placebo orally three times daily with meals for 2 weeks and Nicotinamide Placebo orally twice daily for 2 weeks\n\nLanthanum Carbonate Placebo: Sugar pill manufactured to look like Lanthanum Carbonate tablet\n\nNicotinamide Placebo: Sugar pill manufactured to look like Nicotinamide tablet', 'otherNumAtRisk': 9, 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weeks and Nicotinamide 750mg orally twice daily for 2 weeks\n\nNicotinamide: Nicotinamide tablet\n\nLanthanum Carbonate Placebo: Sugar pill manufactured to look like Lanthanum Carbonate tablet'}, {'id': 'FG003', 'title': 'Lanthanum Placebo + Nicotinamide Placebo', 'description': 'Lanthanum Carbonate Placebo orally three times daily with meals for 2 weeks and Nicotinamide Placebo orally twice daily for 2 weeks\n\nLanthanum Carbonate Placebo: Sugar pill manufactured to look like Lanthanum Carbonate tablet\n\nNicotinamide Placebo: Sugar pill manufactured to look like Nicotinamide tablet'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 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'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '27', 'groupId': 'BG004'}]}]}, {'title': 'African American', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': 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'225.3', 'groupId': 'BG002'}, {'value': '532.2', 'spread': '116.3', 'groupId': 'BG003'}, {'value': '591.8', 'spread': '209.5', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Urine 8 hour Calcium total', 'classes': [{'categories': [{'measurements': [{'value': '50.1', 'groupId': 'BG000', 'lowerLimit': '23.4', 'upperLimit': '76.5'}, {'value': '60.2', 'groupId': 'BG001', 'lowerLimit': '55.8', 'upperLimit': '87.0'}, {'value': '66.4', 'groupId': 'BG002', 'lowerLimit': '36.0', 'upperLimit': '75.9'}, {'value': '57.3', 'groupId': 'BG003', 'lowerLimit': '42.4', 'upperLimit': '65.6'}, {'value': '59.4', 'groupId': 'BG004', 'lowerLimit': '42.4', 'upperLimit': '72.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mg', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Intact FGF23', 'classes': [{'categories': [{'measurements': [{'value': '68.0', 'groupId': 'BG000', 'lowerLimit': '56.1', 'upperLimit': '80.0'}, {'value': '66.9', 'groupId': 'BG001', 'lowerLimit': '41.7', 'upperLimit': '95.5'}, {'value': '54.2', 'groupId': 'BG002', 'lowerLimit': '45.5', 'upperLimit': '66.4'}, {'value': '72.3', 'groupId': 'BG003', 'lowerLimit': '51.6', 'upperLimit': '100.2'}, {'value': '66.2', 'groupId': 'BG004', 'lowerLimit': '47.7', 'upperLimit': '95.5'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'C-terminal FG23', 'classes': [{'categories': [{'measurements': [{'value': '66.3', 'groupId': 'BG000', 'lowerLimit': '60.9', 'upperLimit': '84.4'}, {'value': '82.1', 'groupId': 'BG001', 'lowerLimit': '66.2', 'upperLimit': '100.1'}, {'value': '80.7', 'groupId': 'BG002', 'lowerLimit': '54.8', 'upperLimit': '94.1'}, {'value': '90.7', 'groupId': 'BG003', 'lowerLimit': '61.1', 'upperLimit': '122.8'}, {'value': '79.0', 'groupId': 'BG004', 'lowerLimit': '60.9', 'upperLimit': '100.1'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'RU/ml', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-02-15', 'size': 503010, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-07-07T14:34', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'Double blind, randomized, placebo-controlled, 2x2 factorial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-22', 'studyFirstSubmitDate': '2017-03-23', 'resultsFirstSubmitDate': '2023-07-10', 'studyFirstSubmitQcDate': '2017-04-27', 'lastUpdatePostDateStruct': {'date': '2024-02-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-02-22', 'studyFirstPostDateStruct': {'date': '2017-05-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Intact FGF23', 'timeFrame': 'Approximately 3 weeks.', 'description': 'Longitudinal change in serum intact FGF23 levels from baseline visit through completion of study.'}], 'secondaryOutcomes': [{'measure': 'Change in Plasma Phosphorus Level', 'timeFrame': 'Approximately 3 weeks.', 'description': 'Longitudinal change in plasma phosphorus levels from baseline visit through completion of study.'}, {'measure': 'Change in 24 Hour Urinary Phosphorus Level', 'timeFrame': 'Approximately 3 weeks.', 'description': 'Longitudinal change in 24 hour urinary phosphorus levels from baseline visit through completion of study.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Phosphorus Homeostasis', 'FGF23', 'Vitamin D'], 'conditions': ['Healthy']}, 'referencesModule': {'availIpds': [{'id': 'STU00089165', 'url': 'https://irb.northwestern.edu/contact', 'type': 'Study Protocol'}, {'id': 'STU00089165', 'url': 'https://irb.northwestern.edu/contact', 'type': 'Informed Consent Form'}]}, 'descriptionModule': {'briefSummary': 'STUDY SUMMARY Title: EFFECTS OF NICOTINAMIDE AND LANTHANUM CARBONATE ON PHOSPHORUS HOMEOSTASIS Protocol Number:STU00090161 Phase: Phase 1, detailed physiologic study Methodology: double blind, randomized, placebo-controlled, 2x2 factorial Study Duration: 12-18 months (to complete the entire study protocol) Study Center: Single-center Objectives: Define short-term effects of the interventions (lanthanum carbonate and nicotinamide) on indices of phosphate handling Number of Subjects: 80 Diagnosis and Main Inclusion Criteria: Healthy volunteers Study Product(s), Dose,Route, Regimen: Nicotinamide, 750 mg by mouth twice daily, Lanthanum carbonate, Fosrenol, 1000 mg by mouth three times daily with meals Duration of administration: 2 weeks (length of time study participants are enrolled in study) Reference therapy: reference is a placebo Statistical Methodology: Repeated measures analysis using mixed linear models', 'detailedDescription': 'Chronic kidney disease (CKD) is a growing public health problem that increases risks of endstage renal disease (ESRD), cardiovascular disease (CVD), fractures, and death, and it poses an enormous financial burden on the US health system. Existing therapies modestly impact outcomes. Novel strategies targeting CKD-specific mechanisms are urgently needed to improve health and reduce cost.\n\nCKD is complicated by disordered mineral metabolism, characterized by abnormal calcium and phosphate homeostasis, calcitriol and klotho deficiency, and elevated levels of parathyroid hormone (PTH) and fibroblast growth factor 23 (FGF23). Elevated FGF23 is the earliest and most common manifestation of disordered mineral metabolism. Observational studies report independent associations between elevated phosphate and FGF23 blood levels and increased risks of ESRD, CVD and death. As potential explanatory mechanisms, phosphate excess induces arterial stiffness due to vascular calcification, and FGF23 excess contributes directly to the pathogenesis of left ventricular hypertrophy (LVH). Together, these effects promote CVD events and death.\n\nDietary phosphate absorption is a modifiable determinant of phosphate and FGF23 levels. Small studies of short duration suggest that phosphate binders and dietary phosphate modification in CKD can lower phosphate and FGF23 blood levels by reducing paracellular absorption of phosphate in the gut. However, animal studies demonstrate that compensatory upregulation of transcellular phosphate absorption via the sodium phosphate co-transporter, NPT2b, reduces the efficacy of these approaches. Since nicotinamide lowers plasma phosphate by reducing gut expression of NPT2b,the investigators hypothesize that use of nicotinamide combined with phosphate binders on a background of dietary phosphate moderation will most effectively reduce phosphate and FGF23 blood levels in CKD. The investigators plan to advance this approach in future randomized clinical trials.\n\nThe objective of this study is to perform a detailed physiologic study of healthy volunteers to assess the short-term effects of nicotinamide alone, lanthanum carbonate alone, or both in combination, on phosphate homeostasis. The results from healthy volunteers will provide information needed for optimal design of studies for patients with CKD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'INCLUSION CRITERIA\n\nHealthy volunteers\n\nAge ≥ 18 years, at the time of screening\n\nNormal renal function at screening, as defined by\n\n* eGFR \\> 60\n* no albuminuria\n* normal urinalysis\n* normotensive, defined as blood pressure \\<140/85mmHg\n* no known history of CKD\n\nAdequate organ and marrow function at screening as defined below:\n\n* HCT ≥ 30%\n* platelets ≥ 125,000/mm3\n* total bilirubin within normal institutional limits\n* AST(SGOT)/ALT(SPGT) ≤ 2.5 X institutional upper limit\n* 25-hydroxyvitamin D ≥ 10mg/dL\n\nWomen of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy.\n\nAbility to understand and the willingness to sign a written informed consent.\n\nEXCLUSION CRITERIA:\n\nHistory of allergic reaction to nicotinamide, niacin (excluding flushing), and/or multivitamin preparations\n\nLiver disease, defined as known cirrhosis by imaging or physician diagnosis.\n\n* Documented alcohol use \\> 14 drinks/week\n* Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and/or alkaline phosphatase concentrations \\> 2 times the upper limit of the local laboratory reference range and/or total bilirubin concentration not within institutional limits.\n\nCreatine kinase (CK) concentrations \\> 2 times the upper limit of the local laboratory reference range at screening\n\nMajor hemorrhagic event within the past six months from screening requiring inpatient admission.\n\nBlood or platelet transfusion within the past six months from screening\n\nHistory of primary hyperparathyroidism\n\nCurrent, clinically significant malabsorption\n\nAnemia (screening HCT \\< 30%) at screening\n\nPlasma albumin \\< 2.5 mg/dl at screening\n\n25-hydroxyvitamin D \\<10mg/dL at screening\n\nInability or unwillingness to provide consent\n\nCurrent or recent treatment (within the last 14 days from screening) with niacin/nicotinamide \\> 100 mg/day\n\nCurrent or recent use of MVI containing niacin/nicotinamide \\> 100 mg/day\n\nCurrent use of Tums (or calcium carbonate taken for indigestion) at a dose of \\>1000 mg daily\n\nCurrent participation in another clinical trial or other interventional research'}, 'identificationModule': {'nctId': 'NCT03136705', 'briefTitle': 'Healthy Combine Study', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Short-Term Effects of Nicotinamide and Lanthanum Carbonate on Phosphorus Homeostasis in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'STU00090161'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Lanthanum + Nicotinamide', 'description': 'Lanthanum Carbonate 1000mg orally three times daily with meals for 2 weeks and Nicotinamide 750mg orally twice daily for 2 weeks', 'interventionNames': ['Drug: Nicotinamide', 'Drug: Lanthanum Carbonate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lanthanum + Nicotinamide Placebo', 'description': 'Lanthanum Carbonate 1000mg orally three times daily with meals for 2 weeks and Nicotinamide Placebo orally twice daily for 2 weeks', 'interventionNames': ['Drug: Lanthanum Carbonate', 'Drug: Nicotinamide Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lanthanum Placebo + Nicotinamide', 'description': 'Lanthanum Carbonate Placebo orally three times daily with meals for 2 weeks and Nicotinamide 750mg orally twice daily for 2 weeks', 'interventionNames': ['Drug: Nicotinamide', 'Drug: Lanthanum Carbonate Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Lanthanum Placebo + Nicotinamide Placebo', 'description': 'Lanthanum Carbonate Placebo orally three times daily with meals for 2 weeks and Nicotinamide Placebo orally twice daily for 2 weeks', 'interventionNames': ['Drug: Lanthanum Carbonate Placebo', 'Drug: Nicotinamide Placebo']}], 'interventions': [{'name': 'Nicotinamide', 'type': 'DRUG', 'description': 'Nicotinamide tablet', 'armGroupLabels': ['Lanthanum + Nicotinamide', 'Lanthanum Placebo + Nicotinamide']}, {'name': 'Lanthanum Carbonate', 'type': 'DRUG', 'otherNames': ['Fosrenol'], 'description': 'Lanthanum Carbonate tablet', 'armGroupLabels': ['Lanthanum + Nicotinamide', 'Lanthanum + Nicotinamide Placebo']}, {'name': 'Lanthanum Carbonate Placebo', 'type': 'DRUG', 'otherNames': ['Placebo (for Lanthanum Carbonate 500mg tablet)'], 'description': 'Sugar pill manufactured to look like Lanthanum Carbonate tablet', 'armGroupLabels': ['Lanthanum Placebo + Nicotinamide', 'Lanthanum Placebo + Nicotinamide Placebo']}, {'name': 'Nicotinamide Placebo', 'type': 'DRUG', 'otherNames': ['Placebo (for Nicotinamide 750mg tablet)'], 'description': 'Sugar pill manufactured to look like Nicotinamide tablet', 'armGroupLabels': ['Lanthanum + Nicotinamide Placebo', 'Lanthanum Placebo + Nicotinamide Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Center for Translational Metabolism and Health (CTMH), Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Tamara Isakova, MD, MMSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor Department of Medicine-Nephrology, Director of the Center for Translational Metabolism and Health', 'investigatorFullName': 'Tamara Isakova', 'investigatorAffiliation': 'Northwestern University'}}}}