[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594375":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":35,"centralContacts":39,"locations":46,"responsibleParty":62,"collaborators":61,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":61,"enrollmentInfo":74,"targetDuration":61,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":84,"overallStatus":49,"whyStopped":61,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Dapagliflozin","EXPERIMENTAL","This arm aims to evaluate the potential nephroprotective effect of SGLT2 inhibition using urinary biomarkers of tubular injury.",[13],"Drug: Dapagliflozin 10 MG Oral Tablet",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","This group serves as a control to evaluate the efficacy and safety of dapagliflozin in preventing platinum-induced nephrotoxicity.",[19],"Drug: Placebo Oral Tablet",[21,29],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Dapagliflozin 10 MG Oral Tablet","Participants in this arm will receive oral dapagliflozin 10 mg daily starting one day before platinum-based chemotherapy infusion (cisplatin or carboplatin) and continuing for 72 hours. The intervention aims to assess the potential nephroprotective effect of SGLT2 inhibition. Standard supportive care including hydration and magnesium supplementation will be provided to all participants.",[9],[27,28],"Forxiga","AZD2281",{"type":22,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Placebo Oral Tablet","Participants in this arm will receive a matched oral placebo starting one day before platinum-based chemotherapy infusion (cisplatin or carboplatin) and continuing for 72 hours. Standard supportive care including hydration and magnesium supplementation will also be provided. Investigators and participants will remain blinded to the group assignments.",[15],[34],"Matching placebo",[36],{"name":37,"affiliation":5,"role":38},"Juan M Mejía-Vilet, PhD","PRINCIPAL_INVESTIGATOR",[40],{"name":41,"role":42,"phone":43,"phoneExt":44,"email":45},"Erick Y Zuñiga, MD","CONTACT","+ 52 55 5487 0900","4142","erick.zunigag@incmnsz.mx",[47],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Instituto Nacional de Ciencias Médicas y Nutrición \"Salvador Zubirán\"","RECRUITING","México","Tlalpan","14080","Mexico","MX",{"type":56,"coordinates":57},"Point",[58,59],-108.15213,31.00435,{"lat":59,"lon":58},null,{"type":63,"investigatorFullName":61,"investigatorTitle":61,"investigatorAffiliation":61,"oldNameTitle":61,"oldOrganization":61},"SPONSOR","100594375","phase-2-protecting-the-kidneys-proximal-tubules-from-platinum-based-chemotherapy-toxicity-100594375",false,"NCT07018622","Protecting the Kidney's Proximal Tubules From Platinum-Based Chemotherapy Toxicity","Effect of Sodium-Glucose Cotransporter 2 Inhibition on Urinary Biomarkers of Kidney Injury After Platinum-Based Chemotherapy","DAPA-ARMOR","Inclusion Criteria:\n\n* Signed informed consent form\n* Diagnosis of a solid tumor requiring a platinum-based chemotherapy regimen (cisplatin or carboplatin)\n* Expected survival \\> 4 months\n* ECOG performance status 0-2\n\nExclusion Criteria:\n\n* History of nephrectomy\n* History of kidney transplant\n* Concurrent use of known nephrotoxic drugs (e.g., aminoglycosides, amphotericin B, cyclophosphamide, ifosfamide, methotrexate)\n* Type 1 diabetes mellitus\n* Poorly controlled type 2 diabetes (HbA1c \\> 8% or fasting glucose \\> 200 mg\u002FdL in the past month)\n* Active glomerulopathy\n* Prior use of SGLT2 inhibitors or current indication for their use\n* eGFR \\\u003C 20 ml\u002Fmin\u002F1.73 m²\n* Active urinary tract infection\n* Unresolved obstructive uropathy\n* Participation in another clinical trial\n* History of recurrent genitourinary infections","ALL","18 Years",{"count":75,"type":76},46,"ESTIMATED","INTERVENTIONAL",[79],"PHASE2","Patients with cancer who receive platinum-based chemotherapy are at increased risk of kidney injury caused by these drugs. This form of toxicity can lead to treatment delays, dose reductions, or permanent discontinuation of chemotherapy, all of which can negatively impact cancer outcomes and increase patient morbidity. Despite the clinical significance, there are currently no effective strategies to prevent platinum-induced kidney damage. Existing preventive measures-such as hydration, mannitol use, and magnesium supplementation-are limited and not always effective.\n\nThis clinical trial investigates whether a type of medication known as a Sodium-Glucose Cotransporter 2 (SGLT2) inhibitor, specifically dapagliflozin, can protect the kidneys from damage during platinum-based chemotherapy in patients with solid tumors. Researchers believe that blocking SGLT2 in the kidney may reduce toxicity in the proximal tubules-the area most affected by platinum drugs.\n\nThe primary goal of this study is to compare the levels of a specific urinary biomarker of kidney injury (called KIM-1) 72 hours after chemotherapy, between patients who receive dapagliflozin and those who receive a placebo. Lower levels of this biomarker may indicate that dapagliflozin is helping protect the kidneys.\n\nSecondary goals include comparing additional urinary biomarkers of kidney damage and function-such as EGF (epidermal growth factor), N-acetyl-β-D-glucosaminidase (uNAG), albumin (AlbU), and β2-microglobulin (uβ2-m)-at 72 hours and 7 days after chemotherapy. The study will also assess:\n\nThe percentage of patients who develop acute kidney injury, Changes in estimated glomerular filtration rate (a measure of kidney function), Electrolyte abnormalities (sodium, magnesium, phosphorus), And any adverse events associated with dapagliflozin use. As exploratory objectives, the trial will also evaluate cancer treatment response between groups (using RECIST 1.1 criteria) and the overall safety and tolerability of dapagliflozin compared to placebo.\n\nThis is a randomized, double-blind, placebo-controlled clinical trial, meaning that participants will be randomly assigned to receive either dapagliflozin or a placebo, and neither the patients nor the study team will know who receives which treatment until the study ends.\n\nThe central hypothesis is that dapagliflozin will reduce urinary biomarkers of kidney injury by at least 50% compared to placebo, offering a potential protective strategy against platinum-induced nephrotoxicity without interfering with cancer treatment.",[82,83],"Solid Tumors","Cisplatin Nephrotoxicity",[82,85,86,87,88,89,90,91,92,93,94,95,9],"Platinum-Based Chemotherapy","Cisplatin","Carboplatin","Nephrotoxicity","Kidney Tubules, Proximal","SGLT2 Inhibitors","Kidney Injury Molecule-1","Renal Protection","Chemotherapy-Induced Kidney Injury","Randomized Controlled Trial","Urinary Biomarkers","2026-03-09",{"date":98,"type":99},"2026-03-11","ACTUAL",{"date":101,"type":99},"2025-05-07",{"date":103,"type":76},"2026-10-30",{"name":5,"class":6},1]