Semaglutide for Chronic kidney disease

Inclusion criteria

• {"criterion_text":"- Age ≥ 18\n- Estimated glomerular filtration rate (eGFR) > 20 ml/min/1.73 m2\n- Urine albumin-creatinine ratio as follows: a)\tIf 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.\n- 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\n- Written informed consent"}

Exclusion criteria

• {"criterion_text":"- Contraindications to semaglutide: a) type 1 diabetes\n- Liver disease with serum concentration of ALAT > thrice the upper limit of normal\n- 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)\n- Pregnancy or breastfeeding\n- Unable or unwilling to use secure contraception to avoid pregnancy (women of childbearing potential)\n- Inability to give informed consent\n- Lack of understanding or fluency in either Danish or English\n- 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\n- Contraindications to finerenone: a) treatment with potent cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors or inducers, that cannot be discontinued. b) Addison’s disease\n- Known allergy to any of the ingredients in the study medications\n- Renal disease requiring ongoing immunosuppression, including renal transplantation as well as other organ transplantation\n- Active on the waiting list for organ transplantation or expected to become active within 8 months after inclusion\n- Autosomal Dominant Polycystic Kidney Disease\n- Acute or chronic pancreatitis\n- Severe eating disorder (e.g., anorexia nervosa, bulimia nervosa, binge eating disorder)\n- Chronic Heart failure with ejection fraction < 40%"}

Primary endpoints

• {"endpoint_text":"- The difference in the change in urine albumin-to-creatinine ratio (UACR), based on the average of two morning spot urine samples, between the two groups, measured from baseline to the end of both intervention periods (Intervention period I: semaglutide vs. control, followed by Intervention period II: additional finerenone for all participants).","definition_or_measurement_approach":"UACR measured as the average of two morning spot urine samples; change from baseline to end of both intervention periods comparing the two groups (Intervention period I: semaglutide vs control; Intervention period II: additional finerenone for all participants)."}

Secondary endpoints

• {"endpoint_text":"- Change in urine albumin-to-creatinine ratio from baseline to end of both intervention periods.","definition_or_measurement_approach":"Change in UACR from baseline to end of both intervention periods (measurement method not further specified beyond UACR)."}
• {"endpoint_text":"- Change in urine albumin-to-creatinine ratio from baseline to 20 weeks semaglutide treatment.","definition_or_measurement_approach":"Change in UACR from baseline to 20 weeks of semaglutide treatment (timepoint specified as 20 weeks)."}
• {"endpoint_text":"- Change in urine albumin-to-creatinine ratio from baseline to end of combination therapy (semaglutide followed by additional finerenone), compared to the change during semaglutide treatment alone.","definition_or_measurement_approach":"Compare change in UACR from baseline to end of combination therapy versus change during semaglutide treatment alone (measurement method: UACR)."}

Methods

• K2_Recuritment material Eboks BI_portal (document title present in CTIS documents — recruitment material referencing Eboks and portal)
• K2_Recruitment material annonce (document title present — recruitment announcement)
• K2_Recruitment material opslag (document title present — recruitment posting)
• K2_Recruitment material tidligere interesse AUH (document title referencing prior interest lists at AUH)
• K2_Recuritment material AP RHG / AP Skdstrup (site-specific recruitment materials)
• K1_recruitment arrangements (document title present)

Denmark

Earliest CTIS Part Ii Submission Date

02-09-2025

Latest Decision Or Authorization Date

09-09-2025

Processing Time Days

7

Number Of Sites

2

Number Of Participants

160

Primary sponsor

Full Name

Region Midtjylland

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Aarhus Universitet","duties_or_roles":"Clinical trial monitoring","organisation_type":"Educational Institution"}