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New study aims to uncover hidden kidney risks in type 2 diabetes patients

NCT ID NCT04916132

Knowledge-focused Sponsor: Herlev Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is looking at 300 people with type 2 diabetes who have high levels of protein in their urine, a sign of kidney trouble. Researchers will take small samples of kidney tissue (biopsies) and analyze blood, urine, and stool to find patterns that could improve diagnosis and predict who might get worse. The goal is to learn more about the disease, not to test a new treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2021

Expected to finish

Dec 2043

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

People with type 2 diabetes, albuminuria and eGFR \> 30 who are willing to undergo a kidney biopsy

Ages

18 to 120 years

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 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.

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Conditions

The condition(s) this trial relates to.

Albuminuria chronic kidney disease chronic renal failure syndrome diabetic kidney disease proteinuria type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Albuminuria Chronic kidney diseases Diabetes TYPE2 Diabetic kidney disease Diabetic nephropathies Kidney biopsy Molecular sequence variation

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    13 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Aalborg universitetshospital

    RECRUITING

    Aalborg, Denmark

  • Aarhus Universitetshospital, Skejby

    RECRUITING

    Skejby, Aarhus, 8200, Denmark

  • Herlev Hospital

    RECRUITING

    Herlev, 2730, Denmark

  • Holbæk Hospital

    RECRUITING

    Holbæk, Holbæk, 4300, Denmark

  • Kristine D Schandorff

    RECRUITING

    Hillerød, Hillerød, 3400, Denmark

  • Nykøbing Falster Sygehus

    RECRUITING

    Nykøbing Falster, Nykøbing F, 4800, Denmark

  • Odense universitetshospital

    RECRUITING

    Odense, Denmark

  • Regionshospitalet Gødstrup

    RECRUITING

    Gødstrup, Denmark

  • Rigshospitalet

    RECRUITING

    Copenhagen, København Ø, 2100, Denmark

  • Sjællands Universitetshospital, Køge

    RECRUITING

    Køge, Køge, 4600, Denmark

  • Sjællands Universitetshospital, Roskilde

    RECRUITING

    Roskilde, Roskilde, 4000, Denmark

  • Slagelse Sygehus

    RECRUITING

    Slagelse, Slagelse, 4200, Denmark

  • Steno Diabetes Center Copenhagen

    RECRUITING

    Copenhagen, Gentofte, 2820, Denmark

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