Type 2 Diabetes Trial, Recruiting NCT04916132 Sponsor: Herlev Hospital Condition: Type 2 Diabetes
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Type 2 Diabetes Trial, Recruiting

NCT04916132
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Adults aged 18 years or older
  • People who have been diagnosed with Type 2 diabetes, based on American Diabetes Association criteria
  • People whose kidneys are functioning at a sufficient level, shown by a kidney function test result (eGFR) above 30 mL/min/1.73 m², measured within the last six months
  • People who have high levels of a protein called albumin in their urine, confirmed on more than one test (above 700 mg/g on a spot urine test, or above 700 mg on a 24-hour urine collection)
  • People who are able to provide written informed consent to participate

Who may not be able to join:

  • People who have had signs of sudden (acute) kidney failure in the six months before, or at the time of, the kidney biopsy procedure
  • People whose blood count (haemoglobin) is too low, indicating anaemia that could raise the risk of complications from a kidney biopsy
  • People whose blood clotting test result (INR) is above 1.4 at the time of the biopsy
  • People with a low platelet count (below 100 x 10⁹/L), which affects the blood's ability to clot
  • People with uncontrolled high blood pressure (top number above 160 mmHg and/or bottom number above 100 mmHg)
  • People who have only one functioning kidney
  • People who have a blockage in their urinary tract or fluid build-up around the kidneys at the time of the biopsy
  • People with multiple cysts on both kidneys
  • People who have an active infection in or around the kidneys, or a skin infection over the area where the biopsy would be performed
  • People who are unwilling to receive a blood transfusion if needed
  • People who are unable to lie flat in bed for six hours following the biopsy
  • People who have any other medical reason that the local clinical guidelines consider a reason not to perform a kidney biopsy (confirm with trial site)
  • People who are unable to understand written or spoken information about the trial
  • People who have previously received a kidney transplant
  • People who have previously had a medically performed kidney biopsy
  • Women who are pregnant or planning to become pregnant before the kidney biopsy is carried out
  • People currently being treated with a blood-thinning medication called Marcoumar (phenprocoumon)
  • People who are considered to have a high risk of blood clots and who would need to stop their blood-thinning medication around the time of the biopsy, including those with a mechanical heart valve; certain heart rhythm conditions with additional risk factors or a recent stroke; recent or recurrent blood clots in the veins; or who have had certain recent heart procedures or stent placements (confirm specific timeframes and procedures with trial site)
  • People who are unable to stop taking anti-inflammatory pain medicines (such as ibuprofen or similar NSAIDs) for seven days before the biopsy

Note: Some of the reasons listed above may change over time. If someone does not meet the criteria now due to a reversible condition, the trial site may be able to reassess eligibility at a later date.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 12 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Frederik Persson, MD, PhD, Steno Diabetes Center Copenhagen

Phone: +4561695364

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Herlev Hospital
Registry
ClinicalTrials.gov
Start date
10 August 2021
Est. completion
31 December 2043

Where this trial is recruiting

🇩🇰 Denmark

Primary endpoints

Prevalence

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 12 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov