Actively Recruiting
Diabetic Nephropathy in People With Diabetes. Prevalence and Predictive Factors
Led by Herlev Hospital · Updated on 2025-12-24
300
Participants Needed
13
Research Sites
1168 weeks
Total Duration
On this page
Sponsors
H
Herlev Hospital
Lead Sponsor
R
Rigshospitalet, Denmark
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Diabetic Nephropathy in People With Diabetes. Prevalence and Predictive Factors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Written informed consent
- Diagnosis of Type 2 diabetes as defined by the American Diabetes Association
- Estimated glomerular filtration rate (eGFR) greater than 30 mL/min/1.73 m2 within the last six months
- Urine albumin/creatinine ratio above 700 mg/g or 24-hour urine albumin greater than 700 mg on multiple measurements
You will not qualify if you...
- Signs of acute kidney failure within six months before or at the time of kidney biopsy
- Hemoglobin below 6 mmol/L
- INR above 1.4 at the time of biopsy
- Platelet count less than 100 x 10^9/L
- Uncontrolled high blood pressure (systolic >160 mmHg or diastolic >100 mmHg)
- Only one functioning kidney
- Evidence of urinary tract obstruction or hydronephrosis at biopsy
- Multiple bilateral kidney cysts
- Kidney or surrounding infections at time of biopsy
- Unwillingness to receive blood transfusion
- Unable to lie flat for six hours after biopsy
- Other contraindications for kidney biopsy per local guidelines
- Inability to understand written and oral information
- Previous kidney transplant
- Previous medical kidney biopsy
- Pregnancy or planning pregnancy before biopsy
- Treatment with Marcoumar (other anticoagulants allowed)
- High thromboembolic risk combined with anticoagulation therapy as defined by specific heart valve, atrial fibrillation, stroke, venous thromboembolism, acute coronary syndrome, revascularization, or stroke/TIA timing
- Inability to stop nonsteroidal anti-inflammatory drugs 7 days before biopsy
AI-Screening
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Trial Site Locations
Total: 13 locations
1
Aarhus Universitetshospital, Skejby
Skejby, Aarhus, Denmark, 8200
Actively Recruiting
2
Steno Diabetes Center Copenhagen
Copenhagen, Gentofte, Denmark, 2820
Actively Recruiting
3
Kristine D Schandorff
Hillerød, Hillerød, Denmark, 3400
Actively Recruiting
4
Holbæk Hospital
Holbæk, Holbæk, Denmark, 4300
Actively Recruiting
5
Rigshospitalet
Copenhagen, København Ø, Denmark, 2100
Actively Recruiting
6
Sjællands Universitetshospital, Køge
Køge, Køge, Denmark, 4600
Actively Recruiting
7
Nykøbing Falster Sygehus
Nykøbing Falster, Nykøbing F, Denmark, 4800
Actively Recruiting
8
Sjællands Universitetshospital, Roskilde
Roskilde, Roskilde, Denmark, 4000
Actively Recruiting
9
Slagelse Sygehus
Slagelse, Slagelse, Denmark, 4200
Actively Recruiting
10
Aalborg universitetshospital
Aalborg, Denmark
Actively Recruiting
11
Regionshospitalet Gødstrup
Gødstrup, Denmark
Actively Recruiting
12
Herlev Hospital
Herlev, Denmark, 2730
Actively Recruiting
13
Odense universitetshospital
Odense, Denmark
Actively Recruiting
Research Team
M
Marie Møller
CONTACT
D
Ditte Hansen
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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