Kidney biopsies and biomarkers to study diabetic kidney disease in type 2 diabetes
Studies kidney tissue and body samples in adults with type 2 diabetes and kidney damage.
Plain-language title generated from the registry record
Registry title: Diabetic Nephropathy in People With Diabetes. Prevalence and Predictive Factors
Key facts
- Where
- Aalborg, Copenhagen, Gødstrup, Herlev, Hillerød, Holbæk, Køge, Nykøbing Falster, Odense, Roskilde, Skejby, and Slagelse, DenmarkSee the 13 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 120 years old?
Source: NCT04916132, who can take part
Where in Denmark
- Aalborg UniversitetshospitalAalborg, DenmarkTaking people
- RigshospitaletCopenhagen, DenmarkTaking people
- Steno Diabetes Center CopenhagenCopenhagen, DenmarkTaking people
- Regionshospitalet GødstrupGødstrup, DenmarkTaking people
- Herlev HospitalHerlev, DenmarkTaking people
- Kristine D SchandorffHillerød, DenmarkTaking people
- Holbæk HospitalHolbæk, DenmarkTaking people
- Sjællands Universitetshospital KøgeKøge, DenmarkTaking people
- Nykøbing Falster SygehusNykøbing Falster, DenmarkTaking people
- Odense UniversitetshospitalOdense, DenmarkTaking people
- Sjællands Universitetshospital_RoskildeRoskilde, DenmarkTaking people
- Aarhus Universitetshospital, SkejbySkejby, DenmarkTaking people
- Slagelse SygehusSlagelse, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Herlev Hospital
- Trial code
- NCT04916132
- Record updated
- 24 December 2025
- Original description
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.Read full original descriptionShow less
Biopsy-proven Diabetic Nephropathy in People With Type 2 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 of personalized treatment.
Inclusion: 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: 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; Kidney transplant recipient; Previous medical kidney biopsy; Treatment with Marcoumar (all other anticoagulants are accepted); 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; 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); 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; Women who are pregnant or planning to become pregnant before the kidney biopsy is performed.