Diabetic Nephropathy in People With Diabetes. Prevalence and Predictive Factors (NCT04916132) | Clinical Trial Compass
RecruitingNot Applicable
Diabetic Nephropathy in People With Diabetes. Prevalence and Predictive Factors
Denmark300 participantsStarted 2021-08-10
Plain-language 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 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.
Who can participate
Age range18 Years – 120 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
What they're measuring
1
Prevalence
Timeframe: From baseline to end inclusion (3 years)