Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2025-12-24 @ 9:48 PM
NCT ID:
NCT04916132
Eligibility Criteria:
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.
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT04916132
Study Brief:
Protocol Section:
NCT04916132