Diabetic Nephropathy in People With Diabetes. Prevalence and Predictive Factors

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-120
SponsorHerlev Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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

Hemoglobin < 6 mmol/L

INR >1,4 at the time for biopsy

Platelet count < 100 x 109/l

Trial design

Treatments tested in this trial

  • Kidney Biopsy

Treatment groups

300 Participants
are divided into 1 treatment group

Sponsors and collaborators

Herlev Hospital

Lead sponsor

Rigshospitalet, Denmark

Collaborator

Hillerod Hospital, Denmark

Collaborator

Zealand University Hospital

Collaborator

Holbaek Sygehus

Collaborator

Slagelse Sygehus

Collaborator

Nykøbing Falster County Hospital

Collaborator

Aarhus University Hospital

Collaborator

The Novo Nordisk Foundation Center for Basic Metabolic Research

Collaborator

Novo Nordisk A/S

Collaborator

Gubra ApS

Collaborator

Odense University Hospital

Collaborator

Aalborg University Hospital

Collaborator

Gødstrup Hospital

Collaborator

Steno Diabetes Center Copenhagen

Collaborator

Steno Diabetes Center Sjaelland

Collaborator

Steno Diabetes Center Nordjylland

Collaborator

Michigan Kidney Translational Medical Center

Collaborator