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Semaglutide and Finerenone for Kidney and Vascular Protection in CKD
EU CTIS ID: 2025-522503-18-00
What this study is testing
We aim to investigate the kidney-protective effects of semaglutide and finerenone, individual and in combination, along with their underlying mechanisms of action, in patients with CKD with and without diabetes.
- 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
- Age ≥ 18
- Estimated glomerular filtration rate (eGFR) > 20 ml/min/1.73 m2
- Urine albumin-creatinine ratio as follows: a) If the participant is receiving treatment with both SGLT2i and ACEi/ARB UACR must be > 30 mg/g. b) If the participant is not receiving treatment with either SGLT2i or ACEi/ARB UACR must be > 100 mg/g. c) If the participant is not receiving treatment with one of the two (SGLT2i OR ACEi/ARB) UACR must be > 50 mg/g.
- Specific criteria for each subgroups: a) For subgroup 1: Diabetes mellitus type 2 and HbA1c < 86 mmol/mol at screening b) For subgroup 2: BMI: 21 kg/m2 to 30 kg/m2
- Written informed consent
You likely can't join if
- Contraindications to semaglutide: a) type 1 diabetes
- Liver disease with serum concentration of ALAT > thrice the upper limit of normal
- Any other condition or therapy, which would make the patient unsuitable for this study and will not allow the participation for the full planned study period (e.g., active malignancy or other condition limiting life expectancy to < 12 months)
- Pregnancy or breastfeeding
- Unable or unwilling to use secure contraception to avoid pregnancy (women of childbearing potential)
- Inability to give informed consent
See the full eligibility criteria
- Age ≥ 18
- Estimated glomerular filtration rate (eGFR) > 20 ml/min/1.73 m2
- Urine albumin-creatinine ratio as follows: a) If the participant is receiving treatment with both SGLT2i and ACEi/ARB UACR must be > 30 mg/g. b) If the participant is not receiving treatment with either SGLT2i or ACEi/ARB UACR must be > 100 mg/g. c) If the participant is not receiving treatment with one of the two (SGLT2i OR ACEi/ARB) UACR must be > 50 mg/g.
- Specific criteria for each subgroups: a) For subgroup 1: Diabetes mellitus type 2 and HbA1c < 86 mmol/mol at screening b) For subgroup 2: BMI: 21 kg/m2 to 30 kg/m2
- Written informed consent
- Contraindications to semaglutide: a) type 1 diabetes
- Liver disease with serum concentration of ALAT > thrice the upper limit of normal
- Any other condition or therapy, which would make the patient unsuitable for this study and will not allow the participation for the full planned study period (e.g., active malignancy or other condition limiting life expectancy to < 12 months)
- Pregnancy or breastfeeding
- Unable or unwilling to use secure contraception to avoid pregnancy (women of childbearing potential)
- Inability to give informed consent
- Lack of understanding or fluency in either Danish or English
- Specific for subgroups: a) Subgroup 2: Pre-existing diabetes mellitus defined as: known to have diabetes or treatment with antidiabetic medication other than SGLT2i for cardio- or kidney protective purpose only
- Contraindications to finerenone: a) treatment with potent cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors or inducers, that cannot be discontinued. b) Addison’s disease
- Known allergy to any of the ingredients in the study medications
- Renal disease requiring ongoing immunosuppression, including renal transplantation as well as other organ transplantation
- Active on the waiting list for organ transplantation or expected to become active within 8 months after inclusion
- Autosomal Dominant Polycystic Kidney Disease
- Acute or chronic pancreatitis
- Severe eating disorder (e.g., anorexia nervosa, bulimia nervosa, binge eating disorder)
- Chronic Heart failure with ejection fraction < 40%
The study team makes the final eligibility decision.
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 - 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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.