Urinary proteomics to guide early intervention to prevent complications in type 2 diabetes – a feasibility study
EU CTIS ID: 2024-518682-95-00
What this study is testing
To explore the feasibility of using urinary proteomic signatures in clinical practice to identify patients at risk of developing end organ damage and identify which patients should receive additional reno-cardiovascular protective treatment. We will use urinary proteomic classifiers: CKD273, CAD160 and HF2 to identify patients suited for additional medical treatment with sodium-glucose-cotransporter-2-inhibitors, glucagon-like-peptide-1 receptor agonists or non-steroidal mineralocorticoid receptor antagonist.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Men and women over 18 years of age.
- Type 2 diabetes with no clinical signs of HF NYHA Class IV
- Able to understand the written participant information and give informed consent.
You likely can't join if
- Heart failure NYHA class IV at screening
- Serum potassium > 5.0 mmol/L at the screening visit if the only possible therapy addition at the screening visit is finerenone
- Addison’s Disease, if the only possible therapy addition at the screening visit is finerenone
- Concomitant treatment with strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, ritonavir, nelfinavir, cobicistat, clarithromycin, telithromycin, nefazodone) if the only possible therapy addition at the screening visit is finerenone
- Treatment with a potassium-sparing diuretic (amiloride, triamterene) if the only possible therapy addition at the screening visit is finerenone
- Treatment with other mineralocorticoid receptor antagonist than finerenone (e.g., spironolactone, eplerenone, esaxerenone, canrenone), if the only possible therapy addition at the screening visit is finerenone
See the full eligibility criteria
- Men and women over 18 years of age.
- Type 2 diabetes with no clinical signs of HF NYHA Class IV
- Able to understand the written participant information and give informed consent.
- Heart failure NYHA class IV at screening
- Serum potassium > 5.0 mmol/L at the screening visit if the only possible therapy addition at the screening visit is finerenone
- Addison’s Disease, if the only possible therapy addition at the screening visit is finerenone
- Concomitant treatment with strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, ritonavir, nelfinavir, cobicistat, clarithromycin, telithromycin, nefazodone) if the only possible therapy addition at the screening visit is finerenone
- Treatment with a potassium-sparing diuretic (amiloride, triamterene) if the only possible therapy addition at the screening visit is finerenone
- Treatment with other mineralocorticoid receptor antagonist than finerenone (e.g., spironolactone, eplerenone, esaxerenone, canrenone), if the only possible therapy addition at the screening visit is finerenone
- Elevated Alanine Aminotransferase (ALT) > 3x upper normal limit, autoimmune hepatitis, and/or severe hepatic impairment (including but not limited to a history of hepatic encephalopathy, a history of oesophageal varices or a history of portocaval shunt.)
- Autosomal dominant or autosomal recessive polycystic kidney disease
- Lupus nephritis or ANCA-associated vasculitis, or any other primary or secondary kidney disease requiring immunosuppressive therapy within 6 months prior to screening
- Kidney transplant or dialysis
- Severe or proliferative retinopathy or retinal bleeding, macular edema within 6 months prior to the screening visit, if the only possible therapy addition at the screening visit is semaglutide.
- eGFR < 25 ml/min/1.73m2 at the screening visit
- Any other history, condition, therapy, or uncontrolled intercurrent illness that could, as judged by the investigator, affect participant safety or compliance with study requirements.
- Known or suspected severe abuse of narcotics
- Participant in another intervention study with medicinal product
- Vulnerable (i.e., under guardianship) or mentally incapacitated subjects (i.e., not able to understand and sign the informed consent
- A female who is pregnant, breastfeeding, or intends to become pregnant, or women of childbearing potential (WOCBP) who are not using highly effective contraceptive methods.
- Receiving therapy with all three of the study medication prior to enrolment.
- Myocardial infarction, unstable angina, stroke, or transient ischemic attack within 12 weeks prior to enrolment
- Known or suspected hypersensitivity to all three of the study medications or related products
- History of acute pancreatitis within 6 months prior to the screening visit
- Body mass index < 18.5 kg/m2 at the screening visit if the only possible therapy addition at the screening visit is semaglutide
- Type 1 diabetes
The study team makes the final eligibility decision.
Where it's taking place
- Denmark
- Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Denmark; Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from EU CTIS. The study team decides eligibility, and your own doctor gives medical advice.