Chronic Kidney DiseasesPRIMETIME2NCT04916132
Diabetic Nephropathy in People With Diabetes. Prevalence and Predictive Factors
An observational study of Chronic Kidney Diseases and Albuminuria, run by Herlev Hospital at 13 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Chronic Kidney Diseases, Albuminuria, Diabetic Kidney Disease
- What is being tested?
- Kidney Biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 13 sitesDenmark
- Study dates
- 10 Aug 2021to 31 Dec 2043
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- Adult, Older adult
Study population: People with type 2 diabetes, albuminuria and eGFR > 30 who are willing to undergo a kidney biopsy
Who may be able to join
- 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
Who cannot join
- 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)
Show all 30Show fewer
- 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
- If a participant meets one or more exclusion criteria, that are reversible, the participant can be rescreened later on, to evaluate whether or not the participant now is qualified for participation.
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
Denmark13 sites, 13 recruiting
- Recruiting
Aalborg universitetshospital
Aalborg
Charlotte Strandhave, MD PhD
Peter Vestergaard
- Recruiting
Steno Diabetes Center Copenhagen
Copenhagen, Gentofte, 2820
Peter C Rossing, MD,PHD, PROF, peter.rossing@regionh.dk
Frederik Persson, MD, MDSc, +4527512622, frederik.persson@regionh.dk
- Recruiting
Rigshospitalet
Copenhagen, København Ø, 2100
Mads Copenhagen, MD, PhD, mads.hornum@regionh.dk
Thomas Almdal, MD, MDSc
- Recruiting
Regionshospitalet Gødstrup
Gødstrup
Frank H Mose
- Recruiting
Herlev Hospital
Herlev, 2730
Marie Møller, MD, +4561695364, marie.moeller@regionh.dk
Ditte Hansen, MD, PhD, +4538682056, ditte.hansen.04@regionh.dk
- Recruiting
Kristine D Schandorff
Hillerød, Hillerød, 3400
Kristine D Schandorff, MD, kristine.dyhr.schandorff@regionh.dk
Signe SS Rasmussen, MD, PhD, signe.sabine.saetre.rasmussen@regionh.dk
- Recruiting
Holbæk Hospital
Holbæk, Holbæk, 4300
Morten Lindhardt, MD, PhD, moli@regionsjaelland.dk
Jesper O Christensen, MD, PhD, joc@regionsjaelland.dk
- Recruiting
Sjællands Universitetshospital, Køge
Køge, Køge, 4600
Urd L Kielgast, MD, PhD, ulki@regionsjaelland.dk
- Recruiting
Nykøbing Falster Sygehus
Nykøbing Falster, Nykøbing F, 4800
Allan Kofoed-Enevoldsen, MD, akofo@regionsjaelland.dk
- Recruiting
Odense universitetshospital
Odense
Karoline Schousboe
- Recruiting
Sjællands Universitetshospital, Roskilde
Roskilde, Roskilde, 4000
Rikke Borg, MD, PhD, +4530223200, rbor@regionsjaelland.dk
Karina H Jensen, MD, khr@regionsjaelland.dk
- Recruiting
Aarhus Universitetshospital, Skejby
Skejby, Aarhus, 8200
Johan V Povlsen, MD, PhD, johan.povlsen@skejby.rm.dk
Søren T Knudsen, soerknud@rm.dk
- Recruiting
Slagelse Sygehus
Slagelse, Slagelse, 4200
Eva M Lerche-Black, MD, PhD, emle@regionsjaelland.dk
About this study
Official title: Biopsy-proven Diabetic Nephropathy in People With Type 2 Diabetes. Prevalence and Predictive Factors
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.
Read the detailed description
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
- Chronic Kidney Diseases, Albuminuria, Diabetic Kidney Disease, Diabetic Nephropathies, Diabetes type2, Molecular Sequence Variation
- Being tested
- Kidney Biopsy
- Keywords
- diabetic nephropaty, precision medicine, kidney biopsy
- Medical subject headings
- Renal Insufficiency, Chronic, Albuminuria, Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kidney BiopsyProcedure or surgery
Harvesting of kidney tissue from people with type 2 diabetes and albuminuria for subsequent analysis
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Kidney Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to end inclusion (3 years)
Secondary outcomes (12)
Improved clinical diagnosis
To investigate whether clinical variables, transcriptomic, proteomic and/or metabolomic profiles as well as genetic variation can predict the presence of diabetic nephropathy in a kidney biopsy.
Measured: From baseline to end inclusion (3 years)
diabetic retinopathy
To describe the sensitivity and specificity of diabetic retinopathy in predicting biopsy-proven diabetic nephropathy
Measured: From baseline to end inclusion (3 years)
Kidney Biopsy
describe the prognostic value of different histological and molecular findings on kidney biopsy in individuals with biopsy-proven diabetic nephropathy
Measured: From baseline to end of followup (20 years)
non-diabetic nephropathy vs. biopsy-proven diabetic nephropathy
describe the prognostic value of different histological and molecular findings on the kidney biopsy in individuals with non-diabetic nephropathy compared to biopsy-proven diabetic nephropathy.
Measured: From baseline to end of followup (20 years)
proteomic and metabolomic
describe the prognostic value of the proteomic and metabolomic profiles in biopsy-proven diabetic nephropathy.
Measured: From baseline to end of followup (20 years)
genetic variants
describe the prognostic value of different forms of genetic variation in biopsy-proven diabetic nephropathy
Measured: From baseline to end of followup (20 years)
Microbiome
describe the prognostic value of different compositions of the microbiome and its relation to biopsy and clinical findings
Measured: From baseline to end of followup (20 years)
Annual changes in kidney status
Annual changes in kidney status (defined by yes/no: initiation of dialysis, kidney transplantation, renal death or decrease in eGFR > 40 % compared to eGFR at baseline)
Measured: From baseline to end of followup (20 years)
Annual decline in eGRF
Annual decline in eGRF
Measured: From baseline to end of followup (20 years)
Annual changes in albuminuria.
Annual changes in albuminuria.
Measured: From baseline to end of followup (20 years)
Annual events of cardiovascular disease
Events of cardiovascular disease (fatal CV events, non-fatal stroke, non-fatal myocardial infarction, hospitalization for heart failure, PCI or bypass surgery (heart or legs), amputations due to ischemia, and unstable angina)
Measured: From baseline to end of followup (20 years)
Death
Death (any cause).
Measured: From baseline to end of followup (20 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start10 Aug 2021
- Primary completion31 Dec 2043 (estimated)
- Study completion31 Dec 2043 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, 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
- Responsible party
- Principal investigator, Marie Møller, Herlev Hospital
- Investigators
- Frederik Persson, MD, PhD, Study chair, Steno Diabetes Center Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04916132
- Sponsor's protocol ID
- PRIMETIME2
- Other IDs
- H-20080050
- Acronym
- PRIMETIME2
- Status last verified
- Dec 2025
- First submitted
- 1 Jun 2021
- Last updated
- 24 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This topic is still up for discussion. We do plan to share most of the data, but how, time and place are still undecided
Publications
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.
PubMed 37280026
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biopsy-proven Diabetic Nephropathy in People With Type 2 Diabetes. Prevalence and Predictive Factors
- ClinicalTrials.gov ID
- NCT04916132
- Acronym / sponsor ID
- PRIMETIME2 / PRIMETIME2
- Conditions
- Chronic Kidney Diseases, Albuminuria, Diabetic Kidney Disease, Diabetic Nephropathies, Diabetes type2, Molecular Sequence Variation
- Keywords
- diabetic nephropaty, precision medicine, kidney biopsy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, 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
- Study start
- 10 Aug 2021 (actual)
- Primary completion
- 31 Dec 2043 (estimated)
- Study completion
- 31 Dec 2043 (estimated)
- First posted
- 7 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peolpe with T2DM and albuminuria | – | Procedure: Kidney BiopsyProspectively 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. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- People with type 2 diabetes, albuminuria and eGFR > 30 who are willing to undergo a kidney biopsy
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (30 listed)
- 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:
- Unable to understand written and oral information
- Kidney transplant recipient
- Previous medical kidney biopsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kidney BiopsyHarvesting of kidney tissue from people with type 2 diabetes and albuminuria for subsequent analysis | Procedure or surgery | Peolpe with T2DM and albuminuria |
Primary outcome
Prevalence
Time frame: From baseline to end inclusion (3 years)
To investigate the prevalence of biopsy-proven diabetic nephropathy in individuals with T2DM with severe albuminuria; urine albumin/creatinine ratio (UACR) >700 mg/g.
12 secondary outcomes
Improved clinical diagnosis
Time frame: From baseline to end inclusion (3 years)
diabetic retinopathy
Time frame: From baseline to end inclusion (3 years)
Kidney Biopsy
Time frame: From baseline to end of followup (20 years)
non-diabetic nephropathy vs. biopsy-proven diabetic nephropathy
Time frame: From baseline to end of followup (20 years)
proteomic and metabolomic
Time frame: From baseline to end of followup (20 years)
genetic variants
Time frame: From baseline to end of followup (20 years)
Microbiome
Time frame: From baseline to end of followup (20 years)
Annual changes in kidney status
Time frame: From baseline to end of followup (20 years)
Annual decline in eGRF
Time frame: From baseline to end of followup (20 years)
Annual changes in albuminuria.
Time frame: From baseline to end of followup (20 years)
Annual events of cardiovascular disease
Time frame: From baseline to end of followup (20 years)
Death
Time frame: From baseline to end of followup (20 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Derived from this study: PubMed 37280026Moller 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.
- Individual participant dataSharing planned: Undecided. This topic is still up for discussion. We do plan to share most of the data, but how, time and place are still undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Frederik Persson, MD, PhD study chair
Steno Diabetes Center Copenhagen
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Diseases and Albuminuria, run by Herlev Hospital at 13 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie Møller (+4561695364, marie.moeller@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence (time frame: From baseline to end inclusion (3 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04916132, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.