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The biopsies will be thoroughly investigated with cutting-edge molecular technologies and associated to the biomarkers, disease course and clinical outcome.",[13],"Procedure: Kidney Biopsy",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"PROCEDURE","Kidney Biopsy","Harvesting of kidney tissue from people with type 2 diabetes and albuminuria for subsequent analysis",[9],[21],{"name":22,"affiliation":23,"role":24},"Frederik Persson, MD, PhD","Steno Diabetes Center Copenhagen","STUDY_CHAIR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":10,"email":30},"Marie Møller","CONTACT","+4561695364","marie.moeller@regionh.dk",{"name":32,"role":28,"phone":33,"phoneExt":10,"email":34},"Ditte Hansen","+4538682056","ditte.hansen.04@regionh.dk",[36,57,74,90,106,119,132,146,166,179,192,203,220],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Aarhus Universitetshospital, 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Vestergaard",{"facility":193,"status":38,"city":194,"state":10,"zip":10,"country":42,"countryCode":43,"cosmosGeoPoint":195,"geoPoint":199,"contacts":200},"Regionshospitalet Gødstrup","Gødstrup",{"type":45,"coordinates":196},[197,198],8.89276,56.15584,{"lat":198,"lon":197},[201],{"name":202,"role":28,"phone":10,"phoneExt":10,"email":10},"Frank H Mose",{"facility":5,"status":38,"city":204,"state":10,"zip":205,"country":42,"countryCode":43,"cosmosGeoPoint":206,"geoPoint":210,"contacts":211},"Herlev","2730",{"type":45,"coordinates":207},[208,209],12.43998,55.72366,{"lat":209,"lon":208},[212,214,216,218],{"name":213,"role":28,"phone":29,"phoneExt":10,"email":30},"Marie Møller, MD",{"name":215,"role":28,"phone":33,"phoneExt":10,"email":34},"Ditte Hansen, MD, PhD",{"name":217,"role":165,"phone":10,"phoneExt":10,"email":10},"Iain Bressendorff, MD, PhD",{"name":219,"role":165,"phone":10,"phoneExt":10,"email":10},"Bo Broberg, 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Research",{"name":251,"class":252},"Novo Nordisk A\u002FS","INDUSTRY",{"name":254,"class":255},"Gubra ApS","UNKNOWN",{"name":257,"class":6},"Odense University Hospital",{"name":259,"class":6},"Aalborg University Hospital",{"name":261,"class":6},"Gødstrup Hospital",{"name":23,"class":6},{"name":264,"class":265},"Steno Diabetes Center Sjaelland","OTHER_GOV",{"name":267,"class":6},"Steno Diabetes Center Nordjylland",{"name":269,"class":255},"Michigan Kidney Translational Medical Center","100432824","diabetic-nephropathy-in-people-with-diabetes-prevalence-and-predictive-factors-100432824",false,"NCT04916132","Diabetic Nephropathy in People With Diabetes. Prevalence and Predictive Factors","Biopsy-proven Diabetic Nephropathy in People With Type 2 Diabetes. Prevalence and Predictive Factors","PRIMETIME2","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Written informed consent\n* Diagnosis with T2DM according to the American diabetes Association (20)\n* eGFR \\>30 mL\u002Fmin\u002F1.73 m2 (maximum six months old)\n* urine-albumin\u002Fcreatinine-ratio (uACR) \\> 700 mg\u002Fg or 24 hours urine albumin \\>700 mg on more than one measurement\n\nExclusion Criteria:\n\n* Signs of acute kidney failure according to the KDIGO classification (21) at the time for kidney biopsy or the last 6 months before kidney biopsy\n* Factors that increases the risk of complications due to kidney biopsy:\n\n  * Hemoglobin \\\u003C 6 mmol\u002FL\n  * INR \\>1,4 at the time for biopsy\n  * Platelet count \\\u003C 100 x 109\u002Fl\n  * Uncontrolled high blood pressure (defined as systolic blood pressure \\> 160 mmHg and\u002For diastolic blood pressure \\> 100 mmHg)\n  * Only one functioning kidney\n  * Evidence of urinary tract obstruction or hydronephrosis at the time of biopsy\n  * Multiple bilateral kidney cysts\n  * Kidney infection, peri-renal infection, or cutaneous infection that overlies the kidney at time for biopsy\n  * Unwilling to receive blood transfusion\n  * Unable to lie flat in bed six hours after biopsy\n  * Any other contra-indications for percutaneous kidney biopsy according to local clinical guidelines\n* Unable to understand written and oral information\n* Kidney transplant recipient\n* Previous medical kidney biopsy\n* Women who are pregnant or planning to become pregnant before the kidney biopsy is performed\n* Treatment with Marcoumar (all other anticoagulants are accepted)\n* High thromboembolic risk combined with held in anticoagulation therapy according to the report \"Perioperative regulation of antithrombotic treatment\" (PRAB) (22)\n\n  * mechanical heart valve\n  * atrial fibrillation AND CHA2DS2-VASc\\> 5 and\u002For stroke within the last three months\n  * recurrent venous thromboembolism OR venous thromboembolism within the last three months\n  * less than 6 weeks after uncomplicated Acute Coronary Syndrome (ACS) with or without revascularization (Percutaneous Coronary Intervention (PCI)) with Bare Metal Stents (BMS) or Coronary Artery Bypass Grafting (CABG))\n  * less than 3 months after uncomplicated ACS with revascularization (PCI with Drug Eluting Stent (DES))\n  * less than 9-12 months after complicated ACS (e.g. reinfarction or stent thrombosis)\n  * less than 1 month after revascularization in individuals with stable Coronary Artery Disease (CAD) (PCI with BMS or CABG)\n  * less than 3 months after revascularization in individuals with stable CAD (PCI with DES)\n  * less than 3 months after stroke, or Transient Ischemic Attack (TIA)\n* Inability to withdraw nonsteroidal anti-inflammatory drugs (NSAID) 7 days before biopsy\n\nIf a participant meets one or more exclusion criteria, that are reversible, the participant can be rescreened later on, to evaluate whether or not the participant now is qualified for participation.","ALL","18 Years","120 Years",{"count":282,"type":283},300,"ESTIMATED","OBSERVATIONAL","a prospective, observational, multi-center study with a cohort of 300 patients with Type 2 diabetes and macroalbuminuria. Prospectively we will collect kidney biopsies and analyse the transciptome of the kidney tissue and other biomarkers from blood, faeces, urine, proteomic- and metabolomic profiles and DNA-variants. Thereby we hope to be able to discover molecular and clinical profiles, that can help us in the diagnosis of DKD, and to identify different risks of progression that can benefit from different forms of personalized treatment.",[287,288,289,290,291,292,17],"Chronic Kidney Diseases","Albuminuria","Diabetic Kidney Disease","Diabetic Nephropathies","Diabetes type2","Molecular Sequence Variation",[294,295,296],"diabetic nephropaty","precision medicine","kidney biopsy","2025-12-17",{"date":299,"type":300},"2025-12-24","ACTUAL",{"date":302,"type":300},"2021-08-10",{"date":304,"type":283},"2043-12-31",{"name":5,"class":6},13]