Status:
RECRUITING
Diabetic Nephropathy in People With Diabetes. Prevalence and Predictive Factors
Lead Sponsor:
Herlev Hospital
Collaborating Sponsors:
Rigshospitalet, Denmark
Hillerod Hospital, Denmark
Conditions:
Chronic Kidney Diseases
Albuminuria
Eligibility:
All Genders
18-120 years
Brief Summary
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 ...
Detailed Description
The PRIMETIME project is made to bring together molecular, translational and clinical scientists to create collaborations and build a scientific bridge between diabetology, nephrology, clinical bioche...
Eligibility Criteria
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
- 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.
Key Trial Info
Start Date :
August 10 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2043
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04916132
Start Date
August 10 2021
End Date
December 31 2043
Last Update
December 24 2025
Active Locations (13)
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1
Aarhus Universitetshospital, Skejby
Skejby, Aarhus, Denmark, 8200
2
Steno Diabetes Center Copenhagen
Copenhagen, Gentofte, Denmark, 2820
3
Kristine D Schandorff
Hillerød, Hillerød, Denmark, 3400
4
Holbæk Hospital
Holbæk, Holbæk, Denmark, 4300