Semaglutide and Finerenone for Kidney and Vascular Protection in CKD
Key facts
- Where
- Aarhus N és Herning, DániaSee the 2 sites
- Phase
- 4. fázis
Where in Dánia
- Region MidtjyllandAarhus N, DániaTaking people
- Region MidtjyllandHerning, DániaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Region Midtjylland
- Trial code
- EU 2025-522503-18-00
- Record updated
- 2025. szeptember 9.
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: 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; Active on the waiting list for organ transplantation or expected to become active within 8 months after inclusion; Contraindications to semaglutide: a) type 1 diabetes; 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); 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; Autosomal Dominant Polycystic Kidney Disease; Severe eating disorder (e.g., anorexia nervosa, bulimia nervosa, binge eating disorder); Liver disease with serum concentration of ALAT > thrice the upper limit of normal; Chronic Heart failure with ejection fraction < 40%; 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; Acute or chronic pancreatitis.