Actively Recruiting

Age: 18Years - 120Years
All Genders
ID04916132

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

Led by Herlev Hospital · Updated on 2025-12-24

300

Participants Needed

13

Research Sites

N/A

Total Duration

On this page

Sponsors

H

Herlev Hospital

Lead Sponsor

R

Rigshospitalet, Denmark

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are conducting a prospective, observational study involving 300 patients with Type 2 diabetes and macroalbuminuria to better understand diabetic kidney disease (DKD), the leading cause of end-stage kidney failure. The study aims to improve diagnosis and personalized treatment by analyzing kidney biopsy samples alongside various biomarkers from blood, feces, urine, and molecular profiles. This multi-center project bridges diabetology, nephrology, biochemistry, and pathology to deepen insight into DKD progression and risks. Participants will undergo research kidney biopsies and provide samples for proteomic, metabolomic, and genetic analysis. These biopsies and biomarkers will be examined using advanced molecular techniques and linked to disease progression and clinical outcomes. The study will follow participants over 20 years to observe changes and outcomes related to kidney health, cardiovascular events, and mortality. Throughout the study, participants will be monitored with kidney biopsies, blood and urine tests, and analyses of microbiome and genetic variations. Researchers will track annual kidney function decline, albumin levels, cardiovascular events, and diabetic retinopathy. The primary outcome is the prevalence of biopsy-proven diabetic nephropathy over the initial 3 years, with ongoing follow-up for disease progression and complications until the study's end.

CONDITIONS

Brief Title

Diabetic Nephropathy in People With Diabetes. Prevalence and Predictive Factors

Who Can Participate

Age: 18Years - 120Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Written informed consent
  • Diagnosed with Type 2 diabetes according to the American Diabetes Association
  • Estimated glomerular filtration rate (eGFR) greater than 30 mL/min/1.73 m2 within the last six months
  • Urine albumin to creatinine ratio (uACR) greater than 700 mg/g or 24-hour urine albumin greater than 700 mg on more than one measurement
Not Eligible

You will not qualify if you...

  • Signs of acute kidney failure according to KDIGO classification at or within 6 months before biopsy
  • Hemoglobin less than 6 mmol/L
  • INR greater than 1.4 at time of biopsy
  • Platelet count below 100 x 10^9/L
  • Uncontrolled high blood pressure (systolic >160 mmHg or diastolic >100 mmHg)
  • Having only one functioning kidney
  • Evidence of urinary tract obstruction or hydronephrosis at biopsy
  • Multiple bilateral kidney cysts
  • Kidney or surrounding infections at biopsy time
  • Unwillingness to receive blood transfusion
  • Inability to lie flat for six hours after biopsy
  • Any other contraindications for percutaneous kidney biopsy per local guidelines
  • Inability to understand written and oral information
  • Kidney transplant recipient
  • Previous medical kidney biopsy
  • Women who are pregnant or planning pregnancy before biopsy
  • Treatment with Marcoumar anticoagulant
  • High thromboembolic risk combined with held anticoagulation therapy per guidelines (including mechanical heart valve, recent stroke, venous thromboembolism, or recent coronary interventions)
  • Inability to stop nonsteroidal anti-inflammatory drugs (NSAIDs) 7 days before biopsy

Participants with reversible exclusion criteria may be rescreened later for eligibility.

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Baseline

Participants undergo a kidney biopsy and collection of other biomarkers including blood, faeces, urine, proteomic, metabolomic profiles, and DNA variants for detailed analysis.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 20 years

Participants are followed for up to 20 years with annual assessments to monitor kidney status, kidney function, albuminuria, cardiovascular events, and other clinical outcomes.

Annual visits (in-person or remote)

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

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Research Team

M

Marie Møller

D

Ditte Hansen

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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Published Research Related To This Trial

Rationale and design of a prospective, clinical study of kidney biopsies in people with type 2 diabetes and severely increased albuminuria (the PRIMETIME 2 study).

Marie Møller, Rikke Borg, Iain Bressendorff...

https://pubmed.ncbi.nlm.nih.gov/37280026