Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2026-01-05 @ 6:16 PM
Study NCT ID:
NCT01574157
Status:
COMPLETED
Last Update Posted:
2019-08-28
First Post:
2012-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Investigations of the Optimum Serum Bicarbonate Level in Renal Disease.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], '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'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017693', 'term': 'Sodium Bicarbonate'}], 'ancestors': [{'id': 'D001639', 'term': 'Bicarbonates'}, {'id': 'D002254', 'term': 'Carbonates'}, {'id': 'D002255', 'term': 'Carbonic Acid'}, {'id': 'D017554', 'term': 'Carbon Compounds, Inorganic'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kalani.raphael@va.gov', 'phone': '801-582-1565', 'title': 'Dr. Kalani Raphael, Principal Investigator', 'phoneExt': '1794', 'organization': 'VA Salt Lake City Healthcare System'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Change in urinary levels of Bb and membrane attack complex (MAC) were initial secondary outcomes. However, we had difficulty measuring these. Many subjects could not complete the physical activity assessment, which was an initial secondary outcome.'}}, 'adverseEventsModule': {'timeFrame': "Adverse event data were collected during each participant's 6-month follow-up period.", 'eventGroups': [{'id': 'EG000', 'title': 'Sodium Bicarbonate', 'description': 'Sodium bicarbonate: Participants will receive 0.5 meq of sodium bicarbonate per 1 kilogram of lean body weight daily. The total amount will be divided into twice daily doses.', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 0, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo: Participants will receive an identical number of placebo tablets had they been assigned to the intervention. Placebo will be divided into twice daily doses and receive this for six months.', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 0, 'seriousNumAtRisk': 39, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Urinary Transforming Growth Factor Beta 1 (TGF-b1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sodium Bicarbonate', 'description': 'Participants were prescribed 0.5 meq of sodium bicarbonate per 1 kilogram of lean body weight daily for six months\n\nSodium bicarbonate: Participants will receive 0.5 meq of sodium bicarbonate per 1 kilogram of lean body weight daily. The total amount will be divided into twice daily doses.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were prescribed an identical number of placebo tablets had they been assigned to the intervention, and took this daily for six months.\n\nPlacebo: Participants will receive an identical number of placebo tablets had they been assigned to the intervention. Placebo will be divided into twice daily doses and receive this for six months.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.6', 'groupId': 'OG000', 'lowerLimit': '-9.6', 'upperLimit': '28.0'}, {'value': '-4.4', 'groupId': 'OG001', 'lowerLimit': '-19.4', 'upperLimit': '13.4'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.6', 'ciLowerLimit': '-9.6', 'ciUpperLimit': '40.1', 'groupDescription': 'The primary analysis compared the mean change from baseline in the sodium bicarbonate group to the mean change from baseline in the placebo group.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'The mean of the 3-month and 6-month urinary TGF-b1 measurement will be compared to the baseline value between the groups.', 'description': 'Urinary TGF-b1 is considered a marker of renal fibrosis', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Urinary Levels of Kidney Injury Molecule-1 (KIM-1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sodium Bicarbonate', 'description': 'Participants were prescribed 0.5 meq of sodium bicarbonate per 1 kilogram of lean body weight daily for six months.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were prescribed an identical number of placebo tablets had they been assigned to the intervention, and took this daily for six months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-11.4', 'groupId': 'OG000', 'lowerLimit': '-33.0', 'upperLimit': '17.0'}, {'value': '-1.5', 'groupId': 'OG001', 'lowerLimit': '-24.9', 'upperLimit': '29.2'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.1', 'ciLowerLimit': '-38.2', 'ciUpperLimit': '30.8', 'groupDescription': 'The main analytic strategy for this secondary outcome was a comparison of the mean change from baseline in the sodium bicarbonate group to the mean change from baseline in the placebo group.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'The mean of the 3-month and 6-month measurements will be compared to the baseline values between the groups.', 'description': 'KIM-1 is a marker of of kidney injury.', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Urinary Levels of Neutrophil Gelatinase-associated Lipocalin (NGAL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sodium Bicarbonate', 'description': 'Participants were prescribed 0.5 meq of sodium bicarbonate per 1 kilogram of lean body weight daily for six months\n\nSodium bicarbonate: Participants will receive 0.5 meq of sodium bicarbonate per 1 kilogram of lean body weight daily. The total amount will be divided into twice daily doses.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were prescribed an identical number of placebo tablets had they been assigned to the intervention, and took this daily for six months.\n\nPlacebo: Participants will receive an identical number of placebo tablets had they been assigned to the intervention. Placebo will be divided into twice daily doses and receive this for six months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-28.5', 'groupId': 'OG000', 'lowerLimit': '-48.7', 'upperLimit': '-0.3'}, {'value': '5.9', 'groupId': 'OG001', 'lowerLimit': '-23.9', 'upperLimit': '47.6'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-32.5', 'ciLowerLimit': '-56.3', 'ciUpperLimit': '4.2', 'groupDescription': 'The main analytic strategy for this secondary outcome was a comparison of the mean change from baseline in the sodium bicarbonate group to the mean change from baseline in the placebo group.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'The mean of the 3-month and 6-month measurements will be compared to the baseline values between the groups.', 'description': 'NGAL is a marker of kidney injury', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Urinary Levels of Fibronectin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sodium Bicarbonate', 'description': 'Participants were prescribed 0.5 meq of sodium bicarbonate per 1 kilogram of lean body weight daily for six months.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were prescribed an identical number of placebo tablets had they been assigned to the intervention, and took this daily for six months.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.8', 'groupId': 'OG000', 'lowerLimit': '-9.4', 'upperLimit': '30.7'}, {'value': '1.1', 'groupId': 'OG001', 'lowerLimit': '-15.8', 'upperLimit': '21.3'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.7', 'ciLowerLimit': '-15.1', 'ciUpperLimit': '36.5', 'groupDescription': 'The main analytic strategy for this secondary outcome was a comparison of the mean change from baseline in the sodium bicarbonate group to the mean change from baseline in the placebo group.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'The mean of the 3-month and 6-month measurements will be compared to the baseline values between the groups.', 'description': 'Fibronectin is a marker of kidney injury.', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Urinary Albumin Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sodium Bicarbonate', 'description': 'Sodium bicarbonate: Participants will receive 0.5 meq of sodium bicarbonate per 1 kilogram of lean body weight daily. The total amount will be divided into twice daily doses.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: Participants will receive an identical number of placebo tablets had they been assigned to the intervention. Placebo will be divided into twice daily doses and receive this for six months.'}], 'classes': [{'categories': [{'measurements': [{'value': '21.1', 'groupId': 'OG000', 'lowerLimit': '-3.1', 'upperLimit': '51.3'}, {'value': '11.9', 'groupId': 'OG001', 'lowerLimit': '-10.5', 'upperLimit': '39.8'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.2', 'ciLowerLimit': '-24.6', 'ciUpperLimit': '35.9', 'groupDescription': 'The main analytic strategy for this secondary outcome was a comparison of the mean change from baseline in the sodium bicarbonate group to the mean change from baseline in the placebo group.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'The mean of the 3-month and 6-month measurements will be compared to the baseline values between the groups.', 'description': 'Urinary albumin is a marker of kidney damage', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Estimated Glomerular Filtration (eGFR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sodium Bicarbonate', 'description': 'Sodium bicarbonate: Participants will receive 0.5 meq of sodium bicarbonate per 1 kilogram of lean body weight daily. The total amount will be divided into twice daily doses.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: Participants will receive an identical number of placebo tablets had they been assigned to the intervention. Placebo will be divided into twice daily doses and receive this for six months.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.96', 'groupId': 'OG000', 'lowerLimit': '-0.47', 'upperLimit': '4.40'}, {'value': '-1.41', 'groupId': 'OG001', 'lowerLimit': '-3.80', 'upperLimit': '0.99'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.37', 'ciLowerLimit': '-0.05', 'ciUpperLimit': '6.79', 'groupDescription': 'The main analytic strategy for this secondary outcome was a comparison of the mean change from baseline in the sodium bicarbonate group to the mean change from baseline in the placebo group.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'The mean of the 3-month and 6-month measurements will be compared to the baseline values between the groups.', 'description': 'eGFR is a measure of kidney function', 'unitOfMeasure': 'ml/min per 1.73m2', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sodium Bicarbonate', 'description': 'Participants were prescribed 0.5 meq of sodium bicarbonate per 1 kilogram of lean body weight daily for six months.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participants were prescribed an identical number of placebo tablets had they been assigned to the intervention, and took this daily for six months.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '39'}]}, {'type': 'Month 3', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'comment': 'Month 6', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Participants were recruited from VA Salt Lake City Healthcare System from November 2012 to October 2017.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sodium Bicarbonate', 'description': 'Sodium bicarbonate: Participants will receive 0.5 meq of sodium bicarbonate per 1 kilogram of lean body weight daily. The total amount will be divided into twice daily doses.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo: Participants will receive an identical number of placebo tablets had they been assigned to the intervention. Placebo will be divided into twice daily doses and receive this for six months.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '70', 'spread': '8', 'groupId': 'BG000'}, {'value': '73', 'spread': '8', 'groupId': 'BG001'}, {'value': '72', 'spread': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', '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': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '68', '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': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Estimated glomerular filtration rate', 'classes': [{'categories': [{'measurements': [{'value': '50', 'spread': '20', 'groupId': 'BG000'}, {'value': '52', 'spread': '16', 'groupId': 'BG001'}, {'value': '51', 'spread': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ml/min/1.73m2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Systolic blood pressure', 'classes': [{'categories': [{'measurements': [{'value': '129', 'spread': '12', 'groupId': 'BG000'}, {'value': '127', 'spread': '11', 'groupId': 'BG001'}, {'value': '128', 'spread': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Use of angiotensin converting enzyme-inhibitor (ACE-I) or angiotensin receptor blocker (ARB)', 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Total body weight', 'classes': [{'categories': [{'measurements': [{'value': '100', 'spread': '18', 'groupId': 'BG000'}, {'value': '101', 'spread': '22', 'groupId': 'BG001'}, {'value': '101', 'spread': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Lean body weight', 'classes': [{'categories': [{'measurements': [{'value': '67', 'spread': '8', 'groupId': 'BG000'}, {'value': '68', 'spread': '9', 'groupId': 'BG001'}, {'value': '68', 'spread': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Congestive heart failure', 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Serum total carbon dioxide (CO2)', 'classes': [{'categories': [{'measurements': [{'value': '24', 'spread': '3', 'groupId': 'BG000'}, {'value': '24', 'spread': '2', 'groupId': 'BG001'}, {'value': '24', 'spread': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'meq/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Serum potassium', 'classes': [{'categories': [{'measurements': [{'value': '4.2', 'spread': '0.4', 'groupId': 'BG000'}, {'value': '4.3', 'spread': '0.4', 'groupId': 'BG001'}, {'value': '4.2', 'spread': '0.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'meq/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Hemoglobin A1c', 'classes': [{'categories': [{'measurements': [{'value': '7.5', 'spread': '1.0', 'groupId': 'BG000'}, {'value': '7.6', 'spread': '1.3', 'groupId': 'BG001'}, {'value': '7.5', 'spread': '1.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '%', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Urinary albumin/creatinine', 'classes': [{'categories': [{'measurements': [{'value': '121', 'groupId': 'BG000', 'lowerLimit': '84', 'upperLimit': '412'}, {'value': '131', 'groupId': 'BG001', 'lowerLimit': '46', 'upperLimit': '324'}, {'value': '121', 'groupId': 'BG002', 'lowerLimit': '58', 'upperLimit': '370'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mg/g', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Urinary pH', 'classes': [{'categories': [{'measurements': [{'value': '5.6', 'spread': '0.4', 'groupId': 'BG000'}, {'value': '5.4', 'spread': '0.4', 'groupId': 'BG001'}, {'value': '5.5', 'spread': '0.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Urinary ammonium', 'classes': [{'categories': [{'measurements': [{'value': '36', 'spread': '18', 'groupId': 'BG000'}, {'value': '33', 'spread': '21', 'groupId': 'BG001'}, {'value': '34', 'spread': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'meq/d', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Urinary titratable acids', 'classes': [{'categories': [{'measurements': [{'value': '32', 'spread': '14', 'groupId': 'BG000'}, {'value': '31', 'spread': '16', 'groupId': 'BG001'}, {'value': '32', 'spread': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'meq/d', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Urinary transforming growth factor-B1/creatinine', 'classes': [{'categories': [{'measurements': [{'value': '122', 'groupId': 'BG000', 'lowerLimit': '79', 'upperLimit': '186'}, {'value': '103', 'groupId': 'BG001', 'lowerLimit': '68', 'upperLimit': '147'}, {'value': '112', 'groupId': 'BG002', 'lowerLimit': '74', 'upperLimit': '157'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'ng/g', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Urinary kidney injury molecule-1/creatinine', 'classes': [{'categories': [{'measurements': [{'value': '0.91', 'groupId': 'BG000', 'lowerLimit': '0.57', 'upperLimit': '1.87'}, {'value': '0.88', 'groupId': 'BG001', 'lowerLimit': '0.59', 'upperLimit': '1.89'}, {'value': '0.89', 'groupId': 'BG002', 'lowerLimit': '0.58', 'upperLimit': '1.87'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'ng/mg', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Urinary fibronectin/creatinine', 'classes': [{'categories': [{'measurements': [{'value': '107', 'groupId': 'BG000', 'lowerLimit': '75', 'upperLimit': '194'}, {'value': '97', 'groupId': 'BG001', 'lowerLimit': '65', 'upperLimit': '147'}, {'value': '102', 'groupId': 'BG002', 'lowerLimit': '74', 'upperLimit': '173'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'ng/mg', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Urinary neutrophil gelatinase-associated lipocalin/creatinine', 'classes': [{'categories': [{'measurements': [{'value': '10.5', 'groupId': 'BG000', 'lowerLimit': '7.0', 'upperLimit': '23.6'}, {'value': '11.9', 'groupId': 'BG001', 'lowerLimit': '6.3', 'upperLimit': '24.0'}, {'value': '11.1', 'groupId': 'BG002', 'lowerLimit': '6.5', 'upperLimit': '23.8'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'ng/mg', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-03-22', 'size': 188337, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-06-11T20:09', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-12', 'studyFirstSubmitDate': '2012-03-27', 'resultsFirstSubmitDate': '2019-06-26', 'studyFirstSubmitQcDate': '2012-04-05', 'lastUpdatePostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-08-12', 'studyFirstPostDateStruct': {'date': '2012-04-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Urinary Transforming Growth Factor Beta 1 (TGF-b1)', 'timeFrame': 'The mean of the 3-month and 6-month urinary TGF-b1 measurement will be compared to the baseline value between the groups.', 'description': 'Urinary TGF-b1 is considered a marker of renal fibrosis'}], 'secondaryOutcomes': [{'measure': 'Change in Urinary Levels of Kidney Injury Molecule-1 (KIM-1)', 'timeFrame': 'The mean of the 3-month and 6-month measurements will be compared to the baseline values between the groups.', 'description': 'KIM-1 is a marker of of kidney injury.'}, {'measure': 'Change in Urinary Levels of Neutrophil Gelatinase-associated Lipocalin (NGAL)', 'timeFrame': 'The mean of the 3-month and 6-month measurements will be compared to the baseline values between the groups.', 'description': 'NGAL is a marker of kidney injury'}, {'measure': 'Change in Urinary Levels of Fibronectin', 'timeFrame': 'The mean of the 3-month and 6-month measurements will be compared to the baseline values between the groups.', 'description': 'Fibronectin is a marker of kidney injury.'}, {'measure': 'Change in Urinary Albumin Levels', 'timeFrame': 'The mean of the 3-month and 6-month measurements will be compared to the baseline values between the groups.', 'description': 'Urinary albumin is a marker of kidney damage'}, {'measure': 'Change in Estimated Glomerular Filtration (eGFR)', 'timeFrame': 'The mean of the 3-month and 6-month measurements will be compared to the baseline values between the groups.', 'description': 'eGFR is a measure of kidney function'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Renal Insufficiency', 'Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '35369374', 'type': 'DERIVED', 'citation': 'Gardner J, Tuttle K, Raphael KL. Influence of Medications Containing Acid Salts on Serum Bicarbonate in CKD. Kidney360. 2020 Mar 31;1(5):330-336. doi: 10.34067/KID.0000532019. eCollection 2020 May 28.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to see if treatment with sodium bicarbonate will lower urine levels of proteins that are indicators of kidney damage in people with diabetes who also have chronic kidney disease.', 'detailedDescription': 'Diabetic chronic kidney disease (CKD) is a common problem in Veterans and progresses to end-stage renal disease in many people. It is important to identify treatment strategies that will help prevent the progression of CKD to overt kidney failure. The purpose of this study is to see if sodium bicarbonate reduces urinary markers of kidney damage in Veterans with diabetic CKD and normal serum bicarbonate levels.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Veteran\n* Age older than 18 years\n* Diabetes mellitus\n* Serum bicarbonate 22 - 28 mmol/L on the most recent measurement within the past six months\n* Stage 2, 3, or 4 CKD (defined as estimated glomerular filtration rate (eGFR) 15 - 89 ml/min/1.73m2 using the CKD-Epidemiology equation)\n* Urinary albumin:creatinine ratio \\> 30 mg/gm on the most recent sample within the past 12 months.\n\nExclusion Criteria:\n\n* Lean body weight \\> 100 kg\n* Use of oral medications typically prescribed to raise low serum bicarbonate levels (i.e. sodium bicarbonate, sodium citrate, potassium citrate).\n* Serum potassium \\< 3.5 meq/L at enrollment visit\n* Use of 5 or more antihypertensive agents, regardless of the indications of each agent\n* Systolic blood pressure \\> 140 mmHg or diastolic blood pressure \\> 90 mmHg at the enrollment or baseline visit\n* Diagnosis of congestive heart failure with current, active Class III or IV New York Heart Association symptoms.\n* Significant fluid overload such that it is unsafe in the opinion of the PI for the patient to participate in the trial\n* chronic gastrointestinal disorder or any other factors judged to be likely to limit adherence to interventions (i.e. alcoholism, a history of missing clinic visits)\n* Chronic immunosuppressive therapy for transplanted organs or other indications\n* Individuals who are currently a member of a vulnerable population (I.e. incarcerated, pregnant).\n\n 11.Currently participating in another interventional research study'}, 'identificationModule': {'nctId': 'NCT01574157', 'briefTitle': 'Investigations of the Optimum Serum Bicarbonate Level in Renal Disease.', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Investigations of the Optimum Serum Bicarbonate Level in Renal Disease', 'orgStudyIdInfo': {'id': 'CLIN-002-11F'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sodium Bicarbonate', 'description': 'Participants were prescribed 0.5 meq of sodium bicarbonate per 1 kilogram of lean body weight daily for six months', 'interventionNames': ['Drug: Sodium bicarbonate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants were prescribed an identical number of placebo tablets had they been assigned to the intervention, and took this daily for six months.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Sodium bicarbonate', 'type': 'DRUG', 'description': 'Participants will receive 0.5 meq of sodium bicarbonate per 1 kilogram of lean body weight daily. The total amount will be divided into twice daily doses.', 'armGroupLabels': ['Sodium Bicarbonate']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Participants will receive an identical number of placebo tablets had they been assigned to the intervention. Placebo will be divided into twice daily doses and receive this for six months.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84148', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'VA Salt Lake City Health Care System, Salt Lake City, UT', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Kalani L Raphael, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Salt Lake City Health Care System, Salt Lake City, UT'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}