Diabetic Nephropathy in People With Diabetes. Prevalence and Predictive Factors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-10

Study Completion Date

2043-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The PRIMETIME project is made to bring together molecular, translational and clinical scientists to create collaborations and build a scientific bridge between diabetology, nephrology, clinical biochemistry, and pathology. The ultimately goal is to bring forward an improved understanding of the most frequent cause of end stage renal disease: DKD. We aim to improve the diagnostic accuracy as well as the treatment precision by investigating in detail the features of histology and protein expression in both retrospective(WP1) and prospective(WP2) kidney biopsy material.

PRIMETIME WP2 is a prospective, observational, multi-center study with a cohort of 300 patients. We plan to create a systematically unselected cohort of patients with Type2 diabetes and macroalbuminuria as a sign of kidney injury. 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. The participants will afterward be followed in 20 years.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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Kidney Diseases Albuminuria Diabetic Kidney Disease Diabetic Nephropathies Diabetes type2 Molecular Sequence Variation Kidney Biopsy

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

diabetic nephropaty precision medicine kidney biopsy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Kidney Biopsy

Intervention Type PROCEDURE

Harvesting of kidney tissue from people with type 2 diabetes and albuminuria for subsequent analysis

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Kidney Biopsy

Harvesting of kidney tissue from people with type 2 diabetes and albuminuria for subsequent analysis

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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
* Previous medical kidney biopsy
* Women who are pregnant or planning to become pregnant before the kidney biopsy is performed
* Treatment with Marcoumar (all other anticoagulants are accepted)
* High thromboembolic risk combined with held in anticoagulation therapy according to the report "Perioperative regulation of antithrombotic treatment" (PRAB) (22)

* mechanical heart valve
* atrial fibrillation AND CHA2DS2-VASc\> 5 and/or stroke within the last three months
* recurrent venous thromboembolism OR venous thromboembolism within the last three months
* less than 6 weeks after uncomplicated Acute Coronary Syndrome (ACS) with or without revascularization (Percutaneous Coronary Intervention (PCI)) with Bare Metal Stents (BMS) or Coronary Artery Bypass Grafting (CABG))
* less than 3 months after uncomplicated ACS with revascularization (PCI with Drug Eluting Stent (DES))
* less than 9-12 months after complicated ACS (e.g. reinfarction or stent thrombosis)
* less than 1 month after revascularization in individuals with stable Coronary Artery Disease (CAD) (PCI with BMS or CABG)
* less than 3 months after revascularization in individuals with stable CAD (PCI with DES)
* less than 3 months after stroke, or Transient Ischemic Attack (TIA)
* Inability to withdraw nonsteroidal anti-inflammatory drugs (NSAID) 7 days before biopsy

Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Marie Møller

MD, PhD-student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Frederik Persson, MD, PhD

Role: STUDY_CHAIR

Steno Diabetes Center Copenhagen

Review the countries where the study has at least one active or historical site.

Denmark

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Marie Møller

Role: CONTACT

Phone: +4561695364

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED

PMID: 37280026 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

H-20080050

Identifier Type: OTHER

Identifier Source: secondary_id

PRIMETIME2

Identifier Type: -

Identifier Source: org_study_id

Diabetic Nephropathy in People With Diabetes. Prevalence and Predictive Factors

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Peolpe with T2DM and albuminuria

Kidney Biopsy

Interventions

Kidney Biopsy

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

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

Herlev Hospital

Responsible Party

Marie Møller

Principal Investigators

Frederik Persson, MD, PhD

Locations

Aarhus Universitetshospital, Skejby

Steno Diabetes Center Copenhagen

Kristine D Schandorff

Holbæk Hospital

Rigshospitalet

Sjællands Universitetshospital, Køge

Nykøbing Falster Sygehus

Sjællands Universitetshospital, Roskilde

Slagelse Sygehus

Aalborg universitetshospital

Regionshospitalet Gødstrup

Herlev Hospital

Odense universitetshospital

Countries

Central Contacts

Marie Møller

Ditte Hansen

Facility Contacts

Johan V Povlsen, MD, PhD

Søren T Knudsen

Peter C Rossing, MD,PHD, PROF

Frederik Persson, MD, MDSc

Kristine D Schandorff, MD

Signe SS Rasmussen, MD, PhD

Morten Lindhardt, MD, PhD

Jesper O Christensen, MD, PhD

Mads Copenhagen, MD, PhD

Thomas Almdal, MD, MDSc

Urd L Kielgast, MD, PhD

Allan Kofoed-Enevoldsen, MD

Rikke Borg, MD, PhD

Karina H Jensen, MD

Eva M Lerche-Black, MD, PhD

Charlotte Strandhave, MD PhD

Peter Vestergaard

Frank H Mose

Marie Møller, MD

Ditte Hansen, MD, PhD

Karoline Schousboe

References