[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604913":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":37,"centralContacts":42,"locations":52,"responsibleParty":75,"collaborators":77,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":85,"acronym":55,"eligibilityCriteria":86,"healthyVolunteers":83,"sex":87,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":55,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":99,"overallStatus":104,"whyStopped":55,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Washington D.C. Veterans Affairs Medical Center","FED",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Finerenone","ACTIVE_COMPARATOR","Finerenone 10mg orally daily for 4 months",[13],"Drug: Finerenone 10 MG",{"label":15,"type":10,"description":16,"interventionNames":17},"Empagliflozin","Empagliflozin 10mg orally daily for 4 months",[18],"Drug: Empagliflozin 10 MG",{"label":20,"type":10,"description":21,"interventionNames":22},"Finerenone and Empagliflozin combination","Take 10mg Empagliflozin daily, followed by Fineronone 10mg daily after 4 weeks or 1 month of taking empagliflozin. The combination will continue for 3 months or 12 weeks",[13,18],[24,31],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","Finerenone 10 MG","Take Finerenone 10 mg orally daily",[9,20],[30],"Kerendia",{"type":25,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"Empagliflozin 10 MG","Take Empagliflozin 10 mg orally daily for 4 months",[15,20],[36],"Jardiance",[38],{"name":39,"affiliation":40,"role":41},"Sabyasachi Sen, MD, PhD","Washington DC VA Medical Center","PRINCIPAL_INVESTIGATOR",[43,48],{"name":39,"role":44,"phone":45,"phoneExt":46,"email":47},"CONTACT","202-745-8000","55810","sabyasachi.sen@va.gov",{"name":49,"role":44,"phone":45,"phoneExt":50,"email":51},"Shannen Nicole D Ubalde, MS","55835","shannen.ubalde@va.gov",[53],{"facility":54,"status":55,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Washington DC Veterans Affairs Medical Center (688)",null,"Washington D.C.","District of Columbia","20422","United States","US",{"type":62,"coordinates":63},"Point",[64,65],-77.03637,38.89511,{"lat":65,"lon":64},[68,71],{"name":69,"role":44,"phone":70,"phoneExt":55,"email":47},"Sabyasachi Sen, MD","202-745-8303",{"name":72,"role":44,"phone":45,"phoneExt":73,"email":74},"Ping Li, MD","55910","ping.li2@va.gov",{"type":41,"investigatorFullName":39,"investigatorTitle":76,"investigatorAffiliation":5,"oldNameTitle":55,"oldOrganization":55},"Chief of Endocrinology",[78],{"name":79,"class":80},"Bayer","INDUSTRY","100604913","phase-4-role-of-finerenone-in-african-american-veterans-with-diabetic-kidney-disease-100604913",false,"NCT07155694","Role of Finerenone in African American Veterans With Diabetic Kidney Disease","Inclusion Criteria:\n\n1. Diagnosis of type 2 diabetes (HbA1C at or above 6.5%, or fasting blood glucose of more than 125 or random\u002F post prandial blood glucose of more than 199mg%)\n2. African American veterans\n3. Age 20-90 years\n4. eGFR ≥25-89 mL\u002Fmin\u002F1.73 m2 by the CKD-EPI equation)\n5. Albuminuria of 30 mg\u002Fg or higher\n6. BMI=18-39.9\n7. Blood pressure controlled to ≤140\u002F90\n8. Ability to provide informed consent before any trial related activities are conducted.\n\nExclusion Criteria\n\n1. If a patient is on statin, need to be on a stable dose for a month.\n2. Biopsy proven diagnosis of glomerular disease\u002Fglomerulonephritis\n3. Active smokers,\n4. Active skin wounds undergoing treatment or recent surgery within 1 month (due to possible aberrations in glycemic control)\n5. Women who are pregnant, planning to become pregnant, nursing mothers, women of childbearing potential not using birth control measure\n6. Hypersensitivity to empagliflozin or finerenone\n7. Patients on dialysis\n8. eGFR less than 25 mL\u002Fmin\u002F1.73 m2 by the CKD-EPI equation\n9. Planned surgery or planned hospital admission within 5 months of participation in the study\n10. At the discretion of PI to ensure health, safety, and well-being of the veteran, participation in this study may be stopped (please see withdrawal criteria)\n11. Patients with prior history of diagnosis of heart failure with documented EF of less than 50.\n12. Proven diagnosis of Polycystic Kidney Disease.","ALL","20 Years","90 Years",{"count":91,"type":92},30,"ESTIMATED","INTERVENTIONAL",[95],"PHASE4","Primary Objectives: To study podocyte specific injury markers (podocyte specific proteins, PSP) nephrin, podocalyxin and Wilms'Tumor (WT-1) protein in exosomes urine from African American Veterans with albuminuric stage 2 and 3 chronic diabetic kidney disease (DKD), using Empagliflozin or Finerenone or combination therapy.\n\nSecondary Objectives: (1). Correlate changes in exosome-based PSP with standardized biomarkers of kidney injury including urine albumin\u002Fcreatinine ratio (ACR) and estimated GFR. (2) with systemic inflammatory markers (focusing on vascular and endothelial function) that are already established such as interleukins (IL1, IL6, IL-12), hs-CRP and (3) arterial stiffness measures and with (4) APOL1 mRNA expression levels in peripheral blood derived mononuclear cells (MNC).",[98],"Diabetic Kidney Disease",[15,9,100,101,102,98,103],"Empagliflozin and Finerenone combination","Podocyte Injury","Chronic Kidney Disease","Diabetes Mellitus","NOT_YET_RECRUITING","2025-08-26",{"date":107,"type":108},"2025-09-04","ACTUAL",{"date":110,"type":92},"2025-09",{"date":112,"type":92},"2027-08",{"name":5,"class":6},1]