Understanding Diabetic Kidney Disease in Patients with Type 2 Diabetes

Biopsy-proven Diabetic Nephropathy in People With Type 2 Diabetes. Prevalence and Predictive Factors

This study is trying to understand how kidney disease affects people with Type 2 diabetes and macroalbuminuria by looking at their kidney samples and other health markers over 20 years to improve treatment options.

Quick facts

• Study type: Observational
• Enrollment: 300 (estimated)
• Ages: 18 Years to 120 Years
• Sex: All
• Sponsor: Herlev Hospital (other)
• Locations: 13 sites (Skejby, Aarhus and 12 other locations)
• Trial ID: NCT04916132 on ClinicalTrials.gov

What this trial studies

This observational study aims to investigate the prevalence and predictive factors of diabetic nephropathy in patients with Type 2 diabetes and macroalbuminuria. A cohort of 300 patients will undergo kidney biopsies, and various biomarkers will be collected from blood, urine, and feces to analyze the transcriptome and other profiles. The goal is to enhance diagnostic accuracy and treatment precision by identifying molecular and clinical profiles that indicate risks of disease progression. Participants will be followed for 20 years to assess outcomes and refine personalized treatment approaches.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with Type 2 diabetes and macroalbuminuria.

Not a fit: Patients with acute kidney failure or significant complications that increase biopsy risks may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved diagnosis and personalized treatment options for patients with diabetic kidney disease.

How similar studies have performed: Other studies have shown promise in using molecular profiling to understand diabetic kidney disease, but this specific approach is relatively novel.

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.

Where this trial is running

Skejby, Aarhus and 12 other locations

• Aarhus Universitetshospital, Skejby — Skejby, Aarhus, Denmark (RECRUITING)
• Steno Diabetes Center Copenhagen — Copenhagen, Gentofte, Denmark (RECRUITING)
• Kristine D Schandorff — Hillerød, Hillerød, Denmark (RECRUITING)
• Holbæk Hospital — Holbæk, Holbæk, Denmark (RECRUITING)
• Rigshospitalet — Copenhagen, København Ø, Denmark (RECRUITING)
• Sjællands Universitetshospital, Køge — Køge, Køge, Denmark (RECRUITING)
• Nykøbing Falster Sygehus — Nykøbing Falster, Nykøbing F, Denmark (RECRUITING)
• Sjællands Universitetshospital, Roskilde — Roskilde, Roskilde, Denmark (RECRUITING)
• Slagelse Sygehus — Slagelse, Slagelse, Denmark (RECRUITING)
• Aalborg universitetshospital — Aalborg, Denmark (RECRUITING)
• Regionshospitalet Gødstrup — Gødstrup, Denmark (RECRUITING)
• Herlev Hospital — Herlev, Denmark (RECRUITING)
• Odense universitetshospital — Odense, Denmark (RECRUITING)

Study contacts

• Study coordinator: Marie Møller

Conditions: Chronic Kidney Diseases, Albuminuria, Diabetic Kidney Disease, Diabetic Nephropathies, Diabetes type2, Molecular Sequence Variation, Kidney Biopsy, diabetic nephropaty