[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT02848131":3,"trial-entities:NCT02848131":105,"trial-summary:NCT02848131":109},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":41,"secondary_outcomes":46,"sex":60,"minimum_age":61,"maximum_age":62,"healthy_volunteers":15,"eligibility_criteria":63,"std_ages":67,"locations":70,"central_contacts":88,"overall_officials":89,"references":93,"see_also_links":101},"NCT02848131","15-005843","Senescence in Chronic Kidney Disease","Senescence, Frailty, and Mesenchymal Stem Cell Functionality in Chronic Kidney Disease: Effect of Senolytic Agents","ENROLLING_BY_INVITATION","2027-04","2026-05","2026-05-19","2016-07","Mayo Clinic","OTHER",false,"The study goal is to assess the effect of senescent cell clearance on senescence burden, physical ability or frailty, and adipose tissue-derived mesenchymal stem cell (MSC) functionality in patients with chronic kidney disease (CKD).","The proposed studies will examine cellular senescence and the effect of senolytic therapy on senescent cell burden, frailty, and adipose-derived mesenchymal stem cell function in individuals with diabetic chronic kidney disease.",[19],"Chronic Kidney Disease",[],"INTERVENTIONAL","TREATMENT",[24],"PHASE2",{"count":26,"type":27},30,"ESTIMATED",[29,37],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":35},"DRUG","Group 2: Dasatinib","Dasatinib - take one 100 mg tablet by mouth once daily for 3 consecutive days.",[34],"Group 2: Dasatinib & Quercetin",[36],"Sprycel",{"type":30,"name":38,"description":39,"armGroupLabels":40},"Group 2: Quercetin","Quercetin - take four 250 mg capsules daily (total 1000 mg daily) for 3 consecutive days.",[34],[42],{"measure":43,"description":44,"timeFrame":45},"Change in proportion of senescent cells (representing the total senescent cell burden) present","Assessment of senescence markers in skin, fat, and\u002For blood at baseline and day 14.","Baseline, Day 14",[47,50,53,56],{"measure":48,"description":49,"timeFrame":45},"Change in proportion of senescent mesenchymal stem cells present","Assessment of senescence markers in mesenchymal stem cells at baseline and day 14.",{"measure":51,"description":52,"timeFrame":45},"Change in mesenchymal stem cell function","Assessment of functional studies in mesenchymal stem cells at baseline and day 14. Number of subjects with change in stem cell function related to treatment.",{"measure":54,"description":55,"timeFrame":45},"Change in Frailty index score","Assessment by Fried and other frailty criteria at baseline and day 14.",{"measure":57,"description":58,"timeFrame":59},"Change in kidney function","Assessment by estimated and measured glomerular filtration rate at baseline, day 14, month 4, and month 12.","Baseline, Day 14, Month 4, Month 12","ALL","40 Years","80 Years",{"inclusion":64,"exclusion":65,"raw_text":66},[],[],"Inclusion Criteria:\n\n1. Age 40-80 years\n2. Chronic kidney disease estimated glomerular filtration rate (eGFR) 15-45 ml\u002Fmin\u002F1.73m2\n3. Diabetes mellitus and taking diabetes medications\n\nExclusion Criteria:\n\n1. Concomitant glomerulonephritis,\n2. Nephrotic syndrome,\n3. Solid organ transplantation,\n4. Autosomal dominant or recessive polycystic kidney disease,\n5. Known renovascular disease,\n6. Pregnancy,\n7. Active immunosuppression therapy,\n8. Hemoglobin A1c≥10% at screening,\n9. History of active substance abuse (including alcohol) within the past 2 years,\n10. Current alcohol abuse (\\>3 alcoholic beverages\u002Fday or \\>21 per week),\n11. Body weight \\>150 kg or body mass index\\>50\n12. Human immunodeficiency virus infection\n13. Active hepatitis B or C infection\n14. Tyrosine kinase inhibitor therapy\n15. Known hypersensitivity or allergy to dasatinib or quercetin\n16. Inability to give informed consent\n17. Uncontrolled systemic lupus erythematosus\n18. Uncontrolled pleural\u002Fpericardial effusions or ascites\n19. New invasive cancer except non-melanoma skin cancers\n20. Invasive fungal or viral infection\n21. Inability to tolerate oral medications\n22. Total bilirubin\\>2x upper limit of normal\n23. Subjects taking medications that are sensitive to substrates or substrates with a narrow therapeutic range for CYP3A4, CYP2C8, CYP2C9, or CYP2D6 or strong inhibitors or inducers of CYP3A4 (e.g. cyclosporine, tacrolimus or sirolimus). If antifungals are absolutely necessary from an infectious disease perspective, then they will be allowed only if the levels are therapeutic.\n24. Subjects on strong inhibitors of CYP3A4.\n25. Subjects on therapeutic doses of anticoagulants (Warfarin (Coumadin);Rivaroxaban (Xarleto); Apixaban (Eliquis); Dabigatran (Pradaxa, Prazaxa) or Other).\n26. Subjects on antiplatelet agents ((Clopidogrel (Plavix); Dipyridamole + Asprin (Aggrenox); Ticagrelor (Brilinta); Prasugrel (Effient); Ticlopidine (Ticlid) or Other) who are unable or unwilling to reduce or hold therapy prior to and during the 3-day drug dosing. Subjects may continue their previous regimen on day 4.\n27. Subjects on quinolone antibiotic therapy for treatment or for prevention of infections within 10 days\n28. Subjects taking H2-antagonists or proton pump inhibitors and unwilling to discontinue therapy 1 week prior and 2 weeks following enrollment.\n29. Corrected QT interval (QTc)\\>450 msec\n30. Presence of any condition that the Investigator believes would put the subject at risk or would preclude the patient from successfully completing all aspects of the trial.",[68,69],"ADULT","OLDER_ADULT",[71,80],{"facility":72,"city":73,"state":74,"zip":75,"country":76,"geoPoint":77},"Mayo Clinic Florida","Jacksonville","Florida","32224","United States",{"lat":78,"lon":79},30.33218,-81.65565,{"facility":81,"city":82,"state":83,"zip":84,"country":76,"geoPoint":85},"Mayo Clinic in Rochester","Rochester","Minnesota","55905",{"lat":86,"lon":87},44.02163,-92.4699,[],[90],{"name":91,"affiliation":13,"role":92},"LaTonya J Hickson, MD","PRINCIPAL_INVESTIGATOR",[94,98],{"pmid":95,"type":96,"citation":97},"40152935","DERIVED","Bian X, Snow ZK, Zinn CJ, Gowan CC, Conley SM, Bratulin AL, Elhusseiny KM, Miller J, Tchkonia T, Kirkland JL, Lerman LO, Hickson LJ. Activin A Antagonism with Follistatin Reduces Kidney Fibrosis, Injury, and Cellular Senescence-Associated Inflammation in Murine Diabetic Kidney Disease. Kidney360. 2025 Mar 28;6(8):1278-1291. doi: 10.34067\u002FKID.0000000776.",{"pmid":99,"type":96,"citation":100},"31542391","Hickson LJ, Langhi Prata LGP, Bobart SA, Evans TK, Giorgadze N, Hashmi SK, Herrmann SM, Jensen MD, Jia Q, Jordan KL, Kellogg TA, Khosla S, Koerber DM, Lagnado AB, Lawson DK, LeBrasseur NK, Lerman LO, McDonald KM, McKenzie TJ, Passos JF, Pignolo RJ, Pirtskhalava T, Saadiq IM, Schaefer KK, Textor SC, Victorelli SG, Volkman TL, Xue A, Wentworth MA, Wissler Gerdes EO, Zhu Y, Tchkonia T, Kirkland JL. Senolytics decrease senescent cells in humans: Preliminary report from a clinical trial of Dasatinib plus Quercetin in individuals with diabetic kidney disease. EBioMedicine. 2019 Sep;47:446-456. doi: 10.1016\u002Fj.ebiom.2019.08.069. Epub 2019 Sep 18.",[102],{"label":103,"url":104},"Mayo Clinic Clinical Trials","https:\u002F\u002Fwww.mayo.edu\u002Fresearch\u002Fclinical-trials",{"nct_id":4,"conditions":106,"biomarkers":108},[19,107],"Diabetes Mellitus",[],{"nct_id":4,"found":15,"summary":110,"prompt_version":110},null]