Clinical Trial

Diabetic Nephropathy in People With Diabetes. Prevalence and Predictive Factors

Study acronym: PRIMETIME2
Recruiting
View on ClinicalTrials.gov →
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2021-06-01; most recent amendment 2025-12-17.
Status change: Not Yet Recruiting → Recruiting 2022-03-15
Trial Details
NCT Number NCT04916132
Lead Sponsor Herlev Hospital
Collaborators: Rigshospitalet, Denmark, Hillerod Hospital, Denmark, Zealand University Hospital, Holbaek Sygehus, Slagelse Sygehus, Nykøbing Falster County Hospital, Aarhus University Hospital, The Novo Nordisk Foundation Center for Basic Metabolic Research, Novo Nordisk A/S, Gubra ApS, Odense University Hospital, Aalborg University Hospital, Gødstrup Hospital, Steno Diabetes Center Copenhagen, Steno Diabetes Center Sjaelland, Steno Diabetes Center Nordjylland, Michigan Kidney Translational Medical Center
Conditions Chronic Kidney Diseases, Albuminuria, Diabetic Kidney Disease, Diabetic Nephropathies, Diabetes type2, Molecular Sequence Variation, Kidney Biopsy
Enrollment 300 participants
Start Date 2021-08-10
Primary Completion 2043-12-31 (estimated)
Study Completion 2043-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-12-24