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Diabetic Nephropathy in People With Diabetes. Prevalence and Predictive Factors

Study acronym: PRIMETIME2
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Site details revised at 5 of 13 sitesv4
  2. Study sites: 10 to 13
    • Collaborators: 12 to 17
    v3
  3. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Start date changed from estimate of Jun 15, 2021 to Aug 10, 2021
    • Site details revised at 10 of 10 sites
    • Collaborators: 10 to 12
    • Eligibility criteria expanded, about 4 words
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Herlev Hospital
27 trials monitored
See 3 trials at risk
Diabetes
5,087 trials monitored
See 222 trials at risk
Type 2 Diabetes
2,231 trials monitored
See 111 trials at risk
Chronic Kidney Disease
1,417 trials monitored
See 68 trials at risk
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.
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
(from sponsor)		 Chronic Kidney Diseases, Albuminuria, Diabetic Kidney Disease, Diabetic Nephropathies, Diabetes type2, Molecular Sequence Variation, Kidney Biopsy
Related terms Albuminuria, Diabetic Nephropathies, Renal Insufficiency, Chronic
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov