Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2026-06-21 @ 5:10 PM
Study NCT ID:
NCT03961256
Status:
COMPLETED
Last Update Posted:
2022-10-28
First Post:
2019-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Assess the Efficacy and Safety of Exenatide SR for the Prevention of Diabetes After Kidney Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018149', 'term': 'Glucose Intolerance'}], 'ancestors': [{'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Stegall.Mark@mayo.edu', 'phone': '507-266-2812', 'title': 'Mark D. Stegall, M.D.', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Deaths were assessed up to 20 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 12 months.', 'description': 'Deaths and Adverse Events collected for the Exenatide SR Intervention Group only. Deaths and Adverse Events were not collected for the Standard of Care arm', 'eventGroups': [{'id': 'EG000', 'title': 'Exenatide SR Intervention Group', 'description': 'Subjects received, in addition to standard care, Exenatide SR 2 mg subcutaneous (SQ) weekly for 24 months.\n\nExenatide SR: Exenatide SR 2 mg subcutaneous (SQ) weekly', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression From Prediabetes to Diabetes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide SR Intervention Group', 'description': 'Subjects received, in addition to standard care, Exenatide SR 2 mg subcutaneous (SQ) weekly for 24 months.\n\nExenatide SR: Exenatide SR 2 mg subcutaneous (SQ) weekly'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Subjects received standard post-transplant care as per Mayo Clinic usual practice.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months after transplantation', 'description': 'Number of subjects to have an increase in HbA1C or fasting blood sugar to diabetic range based on the American Diabetes Association (ADA) criteria after kidney transplantation', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Progression From Prediabetes to Diabetes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide SR Intervention Group', 'description': 'Subjects received, in addition to standard care, Exenatide SR 2 mg subcutaneous (SQ) weekly for 24 months.\n\nExenatide SR: Exenatide SR 2 mg subcutaneous (SQ) weekly'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Subjects received standard post-transplant care as per Mayo Clinic usual practice.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 months after transplantation', 'description': 'Number of subjects to have an increase in HbA1C or fasting blood sugar to diabetic range based on the American Diabetes Association (ADA) criteria after kidney transplantation', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected nor analyzed for one subject in the standard of care arm'}, {'type': 'SECONDARY', 'title': 'Creatinine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide SR Intervention Group', 'description': 'Subjects received, in addition to standard care, Exenatide SR 2 mg subcutaneous (SQ) weekly for 24 months.\n\nExenatide SR: Exenatide SR 2 mg subcutaneous (SQ) weekly'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Subjects received standard post-transplant care as per Mayo Clinic usual practice.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000', 'lowerLimit': '1.5', 'upperLimit': '1.9'}, {'value': '1.4', 'groupId': 'OG001', 'lowerLimit': '1.2', 'upperLimit': '1.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From enrollment, up to 20 months post-enrollment', 'description': 'A creatinine blood test measures the level of creatinine in the blood. Creatinine is a waste product that forms when creatine, which is found in the muscle, breaks down. Creatinine levels in the blood can provide the doctors with information about how well the kidneys are working. As measured in mg/dL units.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected nor analyzed for one subject in the standard of care arm'}, {'type': 'SECONDARY', 'title': 'Hemoglobin A1c', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide SR Intervention Group', 'description': 'Subjects received, in addition to standard care, Exenatide SR 2 mg subcutaneous (SQ) weekly for 24 months.\n\nExenatide SR: Exenatide SR 2 mg subcutaneous (SQ) weekly'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Subjects received standard post-transplant care as per Mayo Clinic usual practice.'}], 'classes': [{'title': '12 months', 'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000', 'lowerLimit': '5.3', 'upperLimit': '5.8'}, {'value': '5.85', 'groupId': 'OG001', 'lowerLimit': '5.3', 'upperLimit': '6.4'}]}]}, {'title': '24 months', 'categories': [{'measurements': [{'value': '5.65', 'groupId': 'OG000', 'lowerLimit': '5.6', 'upperLimit': '6.7'}, {'value': '5.75', 'groupId': 'OG001', 'lowerLimit': '5.3', 'upperLimit': '6.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '12 and 24 months after kidney transplantation', 'description': 'Hemoglobin is a protein within red blood cells. As glucose enters the bloodstream, it binds to hemoglobin, or glycates. The more glucose that enters the bloodstream, the higher the amount of glycated hemoglobin. An A1C level below 5.7 percent is considered normal.', 'unitOfMeasure': 'percentage of glycated hemoglobin', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected nor analyzed for one subject in the standard of care arm'}, {'type': 'SECONDARY', 'title': 'Incidence of Mesangial Expansion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide SR Intervention Group', 'description': 'Subjects received, in addition to standard care, Exenatide SR 2 mg subcutaneous (SQ) weekly for 24 months.\n\nExenatide SR: Exenatide SR 2 mg subcutaneous (SQ) weekly'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Subjects received standard post-transplant care as per Mayo Clinic usual practice.'}], 'classes': [{'title': '12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '24 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 and 24 months after kidney transplantation', 'description': 'Number of subjects to experience mesangial expansion \\>20%. Mesangial expansion occurs due to increased deposition of extracellular matrix proteins, for example fibronectin, into the mesangium. Accumulation of extracellular matrix proteins then occurs due to insufficient degradation by matrix metalloproteinases.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected nor analyzed for one subject in the standard of care arm at 24 months'}, {'type': 'SECONDARY', 'title': 'Incidence of Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide SR Intervention Group', 'description': 'Subjects received, in addition to standard care, Exenatide SR 2 mg subcutaneous (SQ) weekly for 24 months.\n\nExenatide SR: Exenatide SR 2 mg subcutaneous (SQ) weekly'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From enrollment, up to 20 months post-enrollment', 'description': 'Number of subjects to experience death by any cause', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Deaths collected for the Exenatide SR Intervention Group only. Deaths were not collected for the Standard of Care arm'}, {'type': 'SECONDARY', 'title': 'Graft Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide SR Intervention Group', 'description': 'Subjects received, in addition to standard care, Exenatide SR 2 mg subcutaneous (SQ) weekly for 24 months.\n\nExenatide SR: Exenatide SR 2 mg subcutaneous (SQ) weekly'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From enrollment, up to 20 months post-enrollment', 'description': 'The number of subjects to experience graft loss. Primary graft failure is defined as no evidence of engraftment or hematological recovery of donor cells, within the first month after transplant, without evidence of disease relapse. Secondary graft failure refers to the loss of a previously functioning graft, resulting in cytopenia involving at least two blood cell lineages.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Graft loss collected for the Exenatide SR Intervention Group only. Graft Loss was not collected for the Standard of Care arm'}, {'type': 'SECONDARY', 'title': 'Adverse Events for Exenatide SR Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide SR Intervention Group', 'description': 'Subjects received, in addition to standard care, Exenatide SR 2 mg subcutaneous (SQ) weekly for 24 months.\n\nExenatide SR: Exenatide SR 2 mg subcutaneous (SQ) weekly'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Total number of adverse events reported by the subjects that received the Exenatide SR Intervention', 'unitOfMeasure': 'Adverse Events', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Exenatide SR Intervention Group', 'description': 'Subjects received, in addition to standard care, Exenatide SR 2 mg subcutaneous (SQ) weekly for 24 months.\n\nExenatide SR: Exenatide SR 2 mg subcutaneous (SQ) weekly'}, {'id': 'FG001', 'title': 'Standard of Care', 'description': 'Subjects received standard post-transplant care as per Mayo Clinic usual practice.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Exenatide SR Intervention Group', 'description': 'Subjects received, in addition to standard care, Exenatide SR 2 mg subcutaneous (SQ) weekly for 24 months.\n\nExenatide SR: Exenatide SR 2 mg subcutaneous (SQ) weekly'}, {'id': 'BG001', 'title': 'Standard of Care', 'description': 'Subjects received standard post-transplant care as per Mayo Clinic usual practice.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.5', 'groupId': 'BG000', 'lowerLimit': '39.0', 'upperLimit': '54.1'}, {'value': '57.7', 'groupId': 'BG001', 'lowerLimit': '42.5', 'upperLimit': '59.2'}, {'value': '53.5', 'groupId': 'BG002', 'lowerLimit': '37.5', 'upperLimit': '57.7'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-02-19', 'size': 824315, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-09-30T09:47', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2021-10-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-03', 'studyFirstSubmitDate': '2019-04-23', 'resultsFirstSubmitDate': '2022-09-01', 'studyFirstSubmitQcDate': '2019-05-22', 'lastUpdatePostDateStruct': {'date': '2022-10-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-10-03', 'studyFirstPostDateStruct': {'date': '2019-05-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-10-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression From Prediabetes to Diabetes', 'timeFrame': '12 months after transplantation', 'description': 'Number of subjects to have an increase in HbA1C or fasting blood sugar to diabetic range based on the American Diabetes Association (ADA) criteria after kidney transplantation'}], 'secondaryOutcomes': [{'measure': 'Progression From Prediabetes to Diabetes', 'timeFrame': '24 months after transplantation', 'description': 'Number of subjects to have an increase in HbA1C or fasting blood sugar to diabetic range based on the American Diabetes Association (ADA) criteria after kidney transplantation'}, {'measure': 'Creatinine', 'timeFrame': 'From enrollment, up to 20 months post-enrollment', 'description': 'A creatinine blood test measures the level of creatinine in the blood. Creatinine is a waste product that forms when creatine, which is found in the muscle, breaks down. Creatinine levels in the blood can provide the doctors with information about how well the kidneys are working. As measured in mg/dL units.'}, {'measure': 'Hemoglobin A1c', 'timeFrame': '12 and 24 months after kidney transplantation', 'description': 'Hemoglobin is a protein within red blood cells. As glucose enters the bloodstream, it binds to hemoglobin, or glycates. The more glucose that enters the bloodstream, the higher the amount of glycated hemoglobin. An A1C level below 5.7 percent is considered normal.'}, {'measure': 'Incidence of Mesangial Expansion', 'timeFrame': '12 and 24 months after kidney transplantation', 'description': 'Number of subjects to experience mesangial expansion \\>20%. Mesangial expansion occurs due to increased deposition of extracellular matrix proteins, for example fibronectin, into the mesangium. Accumulation of extracellular matrix proteins then occurs due to insufficient degradation by matrix metalloproteinases.'}, {'measure': 'Incidence of Death', 'timeFrame': 'From enrollment, up to 20 months post-enrollment', 'description': 'Number of subjects to experience death by any cause'}, {'measure': 'Graft Loss', 'timeFrame': 'From enrollment, up to 20 months post-enrollment', 'description': 'The number of subjects to experience graft loss. Primary graft failure is defined as no evidence of engraftment or hematological recovery of donor cells, within the first month after transplant, without evidence of disease relapse. Secondary graft failure refers to the loss of a previously functioning graft, resulting in cytopenia involving at least two blood cell lineages.'}, {'measure': 'Adverse Events for Exenatide SR Intervention', 'timeFrame': '12 months', 'description': 'Total number of adverse events reported by the subjects that received the Exenatide SR Intervention'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Kidney Transplant'], 'conditions': ['Pre Diabetes']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': "Researchers are trying to determine if an anti-diabetes medication, called Exenatide SR, is well tolerated in kidney transplant patients with elevated blood glucose levels, and if it's effective in preventing diabetes.", 'detailedDescription': "New diabetes can develop after transplant and may affect a transplanted kidney's health and a recipient's overall health. Currently, patients who are pre-diabetic are encouraged to exercise and lose weight. Researchers are planning to test whether an addition of this medication will lead to better results and more effectively prevent diabetes in patients who already have high blood sugars.\n\nExenatide SR is medication given by weekly injection. It increases insulin release in response to a meal and slows digestion. This medicine is already in use and approved by the US Food and Drug Administration (FDA) in patients with diabetes. However, it has not been approved for this indication; the FDA has allowed the use of this drug in this research study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Recipients of solitary kidney transplants (i.e. not combined liver-kidney, pancreas-kidney etc.)\n* At 4 months after transplantation: Prediabetes (fasting blood glucose 100-125 mg/dl; or 2 hr glucose 140-199 or HgbA1c 5.7-6.4%)\n\nExclusion criteria:\n\n* Diabetes pre-transplantation\n* Diabetes at 4 months\n* \\<18 years of age\n* eGFR \\<30 ml/min (estimated by MDRD equation from serum creatinine)\n* Active acute cellular rejection including borderline (If treated and resolved, these patients can be included)\n* BK nephropathy active\n* History of pancreatitis, pre-existing moderate-to-severe gastroparesis, liver cirrhosis or family /personal history of multiple endocrine neoplasia 2 or medullary thyroid cancer\n* Pregnant or breastfeeding women. Female Subject must be either:\n\n * Of non-child bearing potential: Post-menopausal (defined as at least 1 year without any menses) prior to screening , or documented surgically sterile or status post-hysterectomy\n * Or if childbearing potential, agree not to try and become pregnant during the study for at least 90 days after the final study drug administration. And have a negative serum or urine pregnancy test. And if heterosexually active, agree to consistently use two forms of highly effective birth control.\n* Hypersensitivity to Exenatide'}, 'identificationModule': {'nctId': 'NCT03961256', 'briefTitle': 'Assess the Efficacy and Safety of Exenatide SR for the Prevention of Diabetes After Kidney Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'A Phase 2, Prospective, Randomized, Multicenter, Open-Label, Controlled Trial to Assess the Efficacy and Safety of Exenatide SR for the Prevention of Diabetes After Kidney Transplantation.', 'orgStudyIdInfo': {'id': '19-000649'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exenatide SR Intervention Group', 'description': 'Subjects will receive, in addition to standard care, Exenatide SR 2 mg subcutaneous (SQ) weekly for 24 months.', 'interventionNames': ['Drug: Exenatide SR']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of Care', 'description': 'Subjects will receive standard post-transplant care as per Mayo Clinic usual practice.'}], 'interventions': [{'name': 'Exenatide SR', 'type': 'DRUG', 'description': 'Exenatide SR 2 mg subcutaneous (SQ) weekly', 'armGroupLabels': ['Exenatide SR Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Mark D Stegall', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mark Stegall', 'investigatorAffiliation': 'Mayo Clinic'}}}}