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Taking people in DenmarkPhase 4

Testing semaglutide and finerenone for kidney disease

Tests semaglutide and finerenone, alone and together, in adults with chronic kidney disease.

Key facts

Who runs it
Region Midtjylland
Where
Aarhus N and Herning, DenmarkSee the 2 sites
Registry title
Semaglutide and Finerenone for Kidney and Vascular Protection in CKD
Status
Recruiting
Phase
Phase 4
People taking part
160 people, planned
Started
27 Oct 2025
Expected to end
1 Sept 2028
Type of study
Interventional
Record updated
9 September 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with chronic kidney disease, with or without diabetes, who have protein in the urine. It tests semaglutide and finerenone, alone and together.

Age
18 years or older
Sex
All sexes
Disease stage
Chronic kidney disease with eGFR above 20 ml/min/1.73 m2 and a raised urine albumin-creatinine ratio (UACR above 30 mg/g, 50 mg/g or 100 mg/g, depending on SGLT2i and ACEi/ARB treatment). Subgroup 1: type 2 diabetes with HbA1c below 86 mmol/mol (10%). Subgroup 2: BMI 21 kg/m2 to 30 kg/m2.
Earlier treatment
Not required. The urine test level depends on whether the person already takes SGLT2i and ACEi/ARB. Treatment with strong CYP3A4 inhibitors or inducers that cannot be stopped is not allowed.
Biomarker or test result
eGFR above 20 ml/min/1.73 m2; UACR above 30 mg/g, 50 mg/g or 100 mg/g depending on treatment; HbA1c below 86 mmol/mol (10%) for subgroup 1.

Main reasons for not taking part

  • Type 1 diabetes
  • Kidney transplant or other organ transplant, or kidney disease needing ongoing immunosuppression
  • Pregnancy or breastfeeding
  • Active cancer or another condition limiting life expectancy to under 12 months
  • Heart failure with ejection fraction below 40%

The registry criteria, word for word

Show all 21 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in Denmark

  • Region MidtjyllandAarhus N, DenmarkTaking people
  • Region MidtjyllandHerning, DenmarkTaking people

About the trial

What the trial wants to find out

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.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
Semaglutide and Finerenone for Kidney and Vascular Protection in CKD
Plain-language title
Testing semaglutide and finerenone for kidney diseaseGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
9 September 2025