[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627097":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":52,"centralContacts":56,"locations":66,"responsibleParty":84,"collaborators":87,"id":101,"slug":102,"hasResults":103,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":109,"sex":110,"minAge":111,"maxAge":10,"enrollmentInfo":112,"targetDuration":10,"studyType":115,"phases":10,"briefSummary":116,"conditions":117,"keywords":122,"overallStatus":69,"whyStopped":10,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},{"fullName":5,"class":6},"University of Pennsylvania","OTHER",[8,17,21,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Biopsy-confirmed Diabetic Kidney Disease Cohort",null,"Adults with diabetic kidney disease confirmed by a clinically indicated kidney biopsy. This cohort is used to evaluate kidney molecular and histopathologic features in relation to medication exposure history.\n\nInterventions\u002Fexposures of interest (observational): Primary exposure is sodium-glucose cotransporter 2 inhibitors; additional therapy exposures of interest include renin-angiotensin-aldosterone system blockade, glucagon-like peptide-1 receptor agonists, mineralocorticoid receptor antagonists, and other therapies.",[13,14,15,16],"Drug: Sodium-glucose cotransporter 2 inhibitors (SGLT2i)","Drug: Renin-angiotensin-aldosterone system blockade","Drug: Glucagon-like peptide-1 receptor agonists (GLP 1 RA)","Drug: Mineralocorticoid Receptor Antagonists(MRAs)",{"label":18,"type":10,"description":19,"interventionNames":20},"Disease Control Kidney Disease Cohort","Adults with other forms of kidney disease (non-DKD), included as disease controls for cross-disease comparisons of molecular and histologic patterns.\n\nInterventions\u002Fexposures of interest (observational): Medication exposure history is captured to support comparisons across therapy classes, including SGLT2 inhibitors and other disease-modifying therapies.",[13,14,15,16],{"label":22,"type":10,"description":23,"interventionNames":24},"Living Kidney Donor Cohort","Living kidney donors with available donor biopsy tissue, included as a comparator group to provide reference kidney tissue profiles.\n\nInterventions\u002Fexposures of interest (observational): Medication exposure history (including kidney-protective therapies where applicable) may be used in descriptive and comparative analyses; donors primarily serve as a reference\u002Fcontrol tissue cohort.",[13,14,15,16],{"label":26,"type":10,"description":27,"interventionNames":28},"Nephrectomy Control Cohort","Adults undergoing nephrectomy with non-tumor, adjacent normal kidney tissue available, included as a control\u002Freference tissue cohort.\n\nInterventions\u002Fexposures of interest (observational): Medication exposure history (including SGLT2 inhibitors and other kidney-protective therapies) may be incorporated in comparative analyses across cohorts.",[13,14,15,16],[30,37,41,47],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"DRUG","Sodium-glucose cotransporter 2 inhibitors (SGLT2i)","Standard-of-care exposure to sodium-glucose cotransporter 2 inhibitors documented from medication history. Participants are not assigned therapy. Exposure status is used for observational comparisons of kidney tissue molecular and histopathologic features.",[9,18,22,26],[36],"SGLT2 inhibitors",{"type":31,"name":38,"description":39,"armGroupLabels":40,"otherNames":10},"Renin-angiotensin-aldosterone system blockade","Standard-of-care exposure to renin-angiotensin-aldosterone system blockade documented from medication history for observational comparisons.",[9,18,22,26],{"type":31,"name":42,"description":43,"armGroupLabels":44,"otherNames":45},"Glucagon-like peptide-1 receptor agonists (GLP 1 RA)","Standard-of-care exposure documented from medication history for observational comparisons.",[9,18,22,26],[46],"GLP-1 receptor agonists",{"type":31,"name":48,"description":43,"armGroupLabels":49,"otherNames":50},"Mineralocorticoid Receptor Antagonists(MRAs)",[9,18,22,26],[51],"MRAs",[53],{"name":54,"affiliation":5,"role":55},"Katalin Susztak, MD, PhD","PRINCIPAL_INVESTIGATOR",[57,62],{"name":58,"role":59,"phone":60,"phoneExt":10,"email":61},"Gaia Coppock, MD","CONTACT","2673030158","Gaia.Coppock@pennmedicine.upenn.edu",{"name":63,"role":59,"phone":64,"phoneExt":10,"email":65},"Mohammed Al Dulaimee, BS","5853589733","mohammed.aldulaimee@pennmedicine.upenn.edu",[67],{"facility":68,"status":69,"city":70,"state":71,"zip":72,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":81},"Penn Presbyterian Medical Center","RECRUITING","Philadelphia","Pennsylvania","19104","United States","US",{"type":76,"coordinates":77},"Point",[78,79],-75.16362,39.95238,{"lat":79,"lon":78},[82,83],{"name":58,"role":59,"phone":60,"phoneExt":10,"email":61},{"name":63,"role":59,"phone":64,"phoneExt":10,"email":65},{"type":55,"investigatorFullName":85,"investigatorTitle":86,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Katalin Susztak","MD, PhD",[88,91,93,95,97,99],{"name":89,"class":90},"GlaxoSmithKline","INDUSTRY",{"name":92,"class":90},"Boehringer Ingelheim",{"name":94,"class":90},"Regeneron Pharmaceuticals",{"name":96,"class":90},"Novo Nordisk A\u002FS",{"name":98,"class":90},"AstraZeneca",{"name":100,"class":90},"Genentech, Inc.","100627097","transformative-research-in-diabetic-nephropathy-20-100627097",false,"NCT07444203","Transformative Research in Diabetic Nephropathy 2.0","Transformative Research in Diabetic Nephropathy 2.0: A Proof of Principle Study of SGLT2 Inhibitors (TRIDENT 2.0)","TRIDENT 2","Inclusion Criteria:\n\n* Age ≥18 years\n* eGFR ≥10 ml\u002Fmin\u002F1.73 m2 based on the 2021 race-free CKD-EPI equation13\n* Underwent a clinically indicated kidney biopsy, living donor biopsy, or nephrectomy (non-tumor adjacent tissue available).\n* Able and willing to provide informed consent for release of one pathology and clinical data abstraction.\n\nExclusion Criteria:\n\n* Inability to provide informed consent.\n* Archived biopsy or surgical tissue unavailable for slide preparation.\n* Any local institutional policy that prohibits release of H\\&E slides for research.",true,"ALL","18 Years",{"count":113,"type":114},200,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to learn more about kidney health in adults with diabetic kidney disease and other groups. Researchers will study kidney tissue and other samples. They want to learn how sodium-glucose cotransporter-2 (SGLT2) inhibitors, a type of diabetes medicine, may affect the kidneys. People can join only if they are already having a kidney biopsy or kidney surgery as part of their regular medical care.\n\nThe main questions this study aims to answer are:\n\n* Do people who take SGLT2 inhibitors show different biological patterns in kidney tissue than similar people who do not take them?\n* Are these kidney tissue patterns linked with how kidney health changes over time?\n\nResearchers will compare participants who take SGLT2 inhibitors with similar participants who do not take these medicines.\n\nParticipants will:\n\nLet researchers use one stored slide of kidney tissue from their regular care (no extra research biopsy) Give a blood sample and a urine sample Let researchers review medical record information over time",[118,119,120,121],"Diabetic Nephropathies","Kidney Diseases","Renal Insufficiency, Chronic","Diabetes Mellitus, Type 2",[123,124,125,126,127,128],"Diabetic nephropathy","Chronic kidney disease","Diabetic kidney disease","Sodium-glucose cotransporter 2 inhibitors","Spatial transcriptomics","Kidney-protective therapy","2026-02-24",{"date":131,"type":132},"2026-03-02","ACTUAL",{"date":134,"type":132},"2025-11-12",{"date":136,"type":114},"2028-11-12",{"name":5,"class":6},1]