Recruiting

Diabetic Nephropathy in People With Diabetes. Prevalence and Predictive Factors

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…

ClinicalTrials.gov IDNCT04916132
PhaseNot Applicable
Enrollment300
SponsorHerlev Hospital
Age18 Years – 120 Years
SexALL
I'm interested View official listing

Conditions studied

Chronic Kidney Diseases, Albuminuria, Diabetic Kidney Disease, Diabetic Nephropathies, Diabetes type2, Molecular Sequence Variation, Kidney Biopsy

About this study

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.

Interventions

Primary outcomes

Eligibility information

Inclusion Criteria: * Age ≥ 18 years * Written informed consent * Diagnosis with T2DM according to the American diabetes Association (20) * eGFR \>30 mL/min/1.73 m2 (maximum six months old) * urine-albumin/creatinine-ratio (uACR) \> 700 mg/g or 24 hours urine albumin \>700 mg on more than one measurement Exclusion Criteria: * 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 * Factors that increases the risk of complications due to kidney biopsy: * Hemoglobin \< 6 mmol/L * INR \>1,4 at the time for biopsy * Platelet count \< 100 x 109/l * Uncontrolled high blood pressure (defined as systolic blood pressure \> 160 mmHg and/or diastolic blood pressure \> 100 mmHg) * Only one functioning kidney * Evidence of urinary tract obstruction or hydronephrosis at the time of biopsy * Multiple bilateral kidney cysts * Kidney infection, peri-renal infection, or cutaneous infection that overlies the kidney at time for biopsy * Unwilling to receive blood transfusion * Unable to lie flat in bed six hours after biopsy * Any other contra-indications for percutaneous kidney biopsy according to local clinical guidelines * Unable to understand written and oral information * Kidney transplant recipient * Previous medical kidney biopsy * Women who are pregnant or planning to become pregnant before the kidney biopsy is performed * Treatment with Marcoumar (all other anticoagulants are accepted) * High thromboembolic risk combined with held in anticoagulation therapy according to the report "Perioperative regulation of antithrombotic treatment" (PRAB) (22) * mechanical heart valve * atrial fibrillation AND CHA2DS2-VASc\> 5 and/or stroke within the last three months * recurrent venous thromboembolism OR venous thromboembolism within the last three months * 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)) * less than 3 months after uncomplicated ACS with revascularization (PCI with Drug Eluting Stent (DES)) * less than 9-12 months after complicated ACS (e.g. reinfarction or stent thrombosis) * less than 1 month after revascularization in individuals with stable Coronary Artery Disease (CAD) (PCI with BMS or CABG) * less than 3 months after revascularization in individuals with stable CAD (PCI with DES) * less than 3 months after stroke, or Transient Ischemic Attack (TIA) * Inability to withdraw nonsteroidal anti-inflammatory drugs (NSAID) 7 days before biopsy If 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.

Study locations

Showing 10 of 13 reported sites. See the official listing for all locations.

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-21.