Diabetic Nephropathy in People With Diabetes. Prevalence and Predictive Factors
PRIMETIME2
Biopsy-proven Diabetic Nephropathy in People With Type 2 Diabetes. Prevalence and Predictive Factors
2 other identifiers
observational
300
1 country
13
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2021
Longer than P75 for all trials
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 1, 2021
CompletedFirst Posted
Study publicly available on registry
June 7, 2021
CompletedStudy Start
First participant enrolled
August 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2043
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2043
December 24, 2025
December 1, 2025
22.4 years
June 1, 2021
December 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Prevalence
To investigate the prevalence of biopsy-proven diabetic nephropathy in individuals with T2DM with severe albuminuria; urine albumin/creatinine ratio (UACR) \>700 mg/g.
From baseline to end inclusion (3 years)
Secondary Outcomes (12)
Improved clinical diagnosis
From baseline to end inclusion (3 years)
diabetic retinopathy
From baseline to end inclusion (3 years)
Kidney Biopsy
From baseline to end of followup (20 years)
non-diabetic nephropathy vs. biopsy-proven diabetic nephropathy
From baseline to end of followup (20 years)
proteomic and metabolomic
From baseline to end of followup (20 years)
- +7 more secondary outcomes
Study Arms (1)
Peolpe with T2DM and albuminuria
Prospectively we will collect research kidney biopsies and other biomarkers from blood, faeces, urine, proteomic- and metabolomic profiles and DNA-variants. The biopsies will be thoroughly investigated with cutting-edge molecular technologies and associated to the biomarkers, disease course and clinical outcome.
Interventions
Harvesting of kidney tissue from people with type 2 diabetes and albuminuria for subsequent analysis
Eligibility Criteria
People with type 2 diabetes, albuminuria and eGFR \> 30 who are willing to undergo a kidney biopsy
You may qualify if:
- 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)
- urine-albumin/creatinine-ratio (uACR) \> 700 mg/g or 24 hours urine albumin \>700 mg on more than one measurement
You may not qualify if:
- 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
- Factors that increases the risk of complications due to kidney biopsy:
- Hemoglobin \< 6 mmol/L
- INR \>1,4 at the time for biopsy
- Platelet count \< 100 x 109/l
- Uncontrolled high blood pressure (defined as systolic blood pressure \> 160 mmHg and/or diastolic blood pressure \> 100 mmHg)
- Only one functioning kidney
- Evidence of urinary tract obstruction or hydronephrosis at the time of biopsy
- Multiple bilateral kidney cysts
- Kidney infection, peri-renal infection, or cutaneous infection that overlies the kidney at time for biopsy
- Unwilling to receive blood transfusion
- Unable to lie flat in bed six hours after biopsy
- Any other contra-indications for percutaneous kidney biopsy according to local clinical guidelines
- Unable to understand written and oral information
- Kidney transplant recipient
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Herlev Hospitallead
- Zealand University Hospitalcollaborator
- The Novo Nordisk Foundation Center for Basic Metabolic Researchcollaborator
- Novo Nordisk A/Scollaborator
- Gubra ApScollaborator
- Odense University Hospitalcollaborator
- Gødstrup Hospitalcollaborator
- Steno Diabetes Center Copenhagencollaborator
- Steno Diabetes Center Sjaellandcollaborator
- Steno Diabetes Center Nordjyllandcollaborator
- Michigan Kidney Translational Medical Centercollaborator
- Rigshospitalet, Denmarkcollaborator
- Hillerod Hospital, Denmarkcollaborator
- Holbaek Sygehuscollaborator
- Slagelse Sygehuscollaborator
- Nykøbing Falster County Hospitalcollaborator
- Aarhus University Hospitalcollaborator
- Aalborg University Hospitalcollaborator
Study Sites (13)
Aarhus Universitetshospital, Skejby
Skejby, Aarhus, 8200, Denmark
Steno Diabetes Center Copenhagen
Copenhagen, Gentofte, 2820, Denmark
Kristine D Schandorff
Hillerød, Hillerød, 3400, Denmark
Holbæk Hospital
Holbæk, Holbæk, 4300, Denmark
Rigshospitalet
Copenhagen, København Ø, 2100, Denmark
Sjællands Universitetshospital, Køge
Køge, Køge, 4600, Denmark
Nykøbing Falster Sygehus
Nykøbing Falster, Nykøbing F, 4800, Denmark
Sjællands Universitetshospital, Roskilde
Roskilde, Roskilde, 4000, Denmark
Slagelse Sygehus
Slagelse, Slagelse, 4200, Denmark
Aalborg universitetshospital
Aalborg, Denmark
Regionshospitalet Gødstrup
Gødstrup, Denmark
Herlev Hospital
Herlev, 2730, Denmark
Odense universitetshospital
Odense, Denmark
Related Publications (1)
Moller M, Borg R, Bressendorff I, Fink LN, Gravesen E, Jensen KH, Hansen T, Krustrup D, Persson F, Rossing P, Sembach FE, Thuesen ACB, Hansen D. 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). BMJ Open. 2023 Jun 6;13(6):e072216. doi: 10.1136/bmjopen-2023-072216.
PMID: 37280026DERIVED
Biospecimen
Kidney Biopsy (histological and RNA-sequencing) Blood (proteomics, metabolomics and wholegenome sequencing) Urine (Proteomics and metabolomics) Faecal and salvia samples (analysis om the microbiom)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Frederik Persson, MD, PhD
Steno Diabetes Center Copenhagen
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD-student
Study Record Dates
First Submitted
June 1, 2021
First Posted
June 7, 2021
Study Start
August 10, 2021
Primary Completion (Estimated)
December 31, 2043
Study Completion (Estimated)
December 31, 2043
Last Updated
December 24, 2025
Record last verified: 2025-12