[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613715":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":32,"responsibleParty":51,"collaborators":20,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":55,"sex":61,"minAge":62,"maxAge":20,"enrollmentInfo":63,"targetDuration":20,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":20,"overallStatus":72,"whyStopped":20,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Mario Negri Institute for Pharmacological Research","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients","EXPERIMENTAL","Adult Diabetic Kidney Disease (DKD) patients with CKD stages 1 to 3 at moderate or severe risk of renal disease progression.",[13],"Procedure: MRI",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"PROCEDURE","MRI","Multiparametric non-contrast enhanced renal MRI and biochemical analysis to investigate MMP-related pathways (MMP-10 and TIMP-1 serum levels)",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Giuseppe Remuzzi, M.D.","Istituto Di Ricerche Farmacologiche Mario Negri","STUDY_DIRECTOR",[27],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Anna Caroli, PhD","CONTACT","+390354535381","anna.caroli@marionegri.it",[33],{"facility":34,"status":20,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Clinical Research Centre for Rare Diseases Aldo e Cele Daccò","Ranica","BG","24020","Italy","IT",{"type":41,"coordinates":42},"Point",[43,44],9.71335,45.72328,{"lat":44,"lon":43},[47],{"name":48,"role":29,"phone":49,"phoneExt":20,"email":50},"Matias Trillini, MD","+390354535411","matias.trillini@marionegri.it",{"type":52,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100613715","mechanisms-underlying-sglt2i-kidney-effect-in-dkd-progression-100613715",false,"NCT07270198","Mechanisms Underlying SGLT2i Kidney Effect in DKD Progression","Longitudinal Multicentre Clinical Study to Explore the Mechanisms Underlying Kidney Effect of SGLT2i in Diabetic Kidney Disease Patients at Risk of Disease Progression by Multiparametric Renal MRI and Biochemical Markers","PERSONALISEDKD","Inclusion Criteria (to be eligible to participate in this trial, an individual must meet all the following criteria):\n\n* male and female subjects aged ≥ 18 years;\n* written informed consent prior to any study specific procedures\n* type 2 Diabetes Mellitus with DKD\n* CKD stage 1 to 3 (eGFR\\>30 ml\u002Fmin) with moderate or severe risk of renal disease progression (according to KDIGO 2024 CKD guidelines, G1 and G2 with albuminuria \\>300 mg\u002Fg, G3a with albuminuria \\>30 mg\u002Fg, and G3b independently of albuminuria levels)\n* ongoing SGLT2i treatment (e.g. canagliflozin, empagliflozin or dapagliflozin) for at least 1 year and stable RAS inhibitor therapy with ACE inhibitors and\u002For ARBs (or without RAS inhibitors in patients with specific contraindications for this medication)\n\nExclusion Criteria (an individual who meets any of the following criteria will be excluded from participation in this trial):\n\n* Uncontrolled diabetes (glycated hemoglobin (A1C) \\> 8%; 64 mmol\u002Fmol)\n* Contraindications to MRI including claustrophobia, pregnancy or lactating, cardiac pacemakers, or other MRI-incompatible prostheses, or impossibility to perform MRI\n* Any chronic clinical condition (e.g. history of malignancy) other than CKD and related complications that could affect completion of the trial or confound data interpretation\n* Non-diabetic CKD: CKD highly suspected to be related with a different renal condition other than Diabetes Mellitus as the cause of CKD (i.e. glomerular disease, tubulo-interstitial nephritis, microangiopathic thrombotic disease, renovascular\u002Fischemic kidney disease, etc)\n* Active systemic autoimmune diseases\n* Concomitant treatment with steroids or any other immunosuppressive agent\n* Chronic heart failure with New York Heart Association class III-IV at the screening visit\n* Intention to become pregnant in the following 2 years (female patients)\n* Drug or alcohol abuse","ALL","18 Years",{"count":64,"type":65},100,"ESTIMATED","INTERVENTIONAL",[68],"NA","This is a multicentre and multi-national non-pharmacological, uncontrolled interventional study conducted in a clinical practice setting in DKD patients with CKD stages 1 to 3 with moderate or severe risk of renal function decline in chronic treatment with SGLT2i.\n\nThe main aim of the study is to assess the independent role of baseline individual mpMRI markers (hemodynamic, oxygenation, microstructure, perfusion, and fat fraction) and biochemical markers of MMP-related pathways (MMP-10 and TIMP-1) in the prediction of chronic eGFR decline in the above mentioned patients who are on chronic SGLT2i therapy.",[71],"Diabetic Kidney Disease (DKD)","NOT_YET_RECRUITING","2025-11-25",{"date":75,"type":76},"2025-12-08","ACTUAL",{"date":78,"type":65},"2026-02",{"date":80,"type":65},"2027-08",{"name":5,"class":6},1]