Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
160
Countries
1
Sites
2
Chronic kidney disease
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.
Key facts
- Sponsor
- Region Midtjylland
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Pathological Conditions, Signs and Symptoms [C23]
- Trial duration
- 27 Oct 2025 → ongoing
- Decision date (initial)
- 2025-09-09
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy
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.
Conditions and MedDRA coding
Chronic kidney disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 23.1 | PT | 10064848 | Chronic kidney disease | 100000004857 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- 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 criteria 16
- Contraindications to semaglutide: a) type 1 diabetes
- 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%
- 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
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 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).
Secondary endpoints 3
- Change in urine albumin-to-creatinine ratio from baseline to end of both intervention periods.
- Change in urine albumin-to-creatinine ratio from baseline to 20 weeks semaglutide treatment.
- 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.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 8
Ozempic 0.5 mg solution for injection in pre-filled pen
PRD6392562 · Product
- Active substance
- Semaglutide
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INJECTION
- Max daily dose
- 1 mg milligram(s)
- Max total dose
- 30 mg milligram(s)
- Max treatment duration
- 30 Week(s)
- Authorisation status
- Authorised
- ATC code
- A10BJ06 — -
- Marketing authorisation
- EU/1/17/1251/003
- MA holder
- NOVO NORDISK A/S
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Ozempic 1 mg solution for injection in pre-filled pen
PRD6392564 · Product
- Active substance
- Semaglutide
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INJECTION
- Max daily dose
- 1 mg milligram(s)
- Max total dose
- 30 mg milligram(s)
- Max treatment duration
- 30 Week(s)
- Authorisation status
- Authorised
- ATC code
- A10BJ06 — -
- Marketing authorisation
- EU/1/17/1251/005
- MA holder
- NOVO NORDISK A/S
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Ozempic 0.5 mg solution for injection in pre-filled pen
PRD11350768 · Product
- Active substance
- Semaglutide
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INJECTION
- Max daily dose
- 1 mg milligram(s)
- Max total dose
- 30 mg milligram(s)
- Max treatment duration
- 30 Week(s)
- Authorisation status
- Authorised
- ATC code
- A10BJ06 — -
- Marketing authorisation
- EU/1/17/1251/012
- MA holder
- NOVO NORDISK A/S
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Ozempic 0.25 mg solution for injection in pre-filled pen
PRD6392561 · Product
- Active substance
- Semaglutide
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INJECTION
- Max daily dose
- 1 mg milligram(s)
- Max total dose
- 30 mg milligram(s)
- Max treatment duration
- 30 Week(s)
- Authorisation status
- Authorised
- ATC code
- A10BJ06 — -
- Marketing authorisation
- EU/1/17/1251/002
- MA holder
- NOVO NORDISK A/S
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Kerendia 10 mg film coated tablets
PRD9506150 · Product
- Active substance
- Finerenone
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 240 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- C03DA05 — -
- Marketing authorisation
- EU/1/21/1616/002
- MA holder
- BAYER AG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Kerendia 20 mg film-coated tablets
PRD9506430 · Product
- Active substance
- Finerenone
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 240 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- C03DA05 — -
- Marketing authorisation
- EU/1/21/1616/006
- MA holder
- BAYER AG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Kerendia 10 mg film coated tablets
PRD9506151 · Product
- Active substance
- Finerenone
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 240 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- C03DA05 — -
- Marketing authorisation
- EU/1/21/1616/001
- MA holder
- BAYER AG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Kerendia 20 mg film-coated tablets
PRD9506429 · Product
- Active substance
- Finerenone
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 240 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- C03DA05 — -
- Marketing authorisation
- EU/1/21/1616/007
- MA holder
- BAYER AG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Region Midtjylland
- Sponsor organisation
- Region Midtjylland
- Address
- Palle Juul-Jensens Boulevard 99
- City
- Aarhus N
- Postcode
- 8200
- Country
- Denmark
Scientific contact point
- Organisation
- Region Midtjylland
- Contact name
- Mette Øhrstrøm
Public contact point
- Organisation
- Region Midtjylland
- Contact name
- Mette Øhrstrøm
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Aarhus Universitet ORG-100028380
|
Aarhus N, Denmark | Other |
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 160 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2025-10-27 | 2025-10-30 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 21 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2025-522503-18-00 | 2.00 |
| Recruitment arrangements (for publication) | K1_recruitment arrangements | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material tidligere interesse RHG | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material annonce | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material AP RHG | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material opslag | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material tidligere interesse AUH | 3.0 |
| Recruitment arrangements (for publication) | K2_Recuritment material AP Skdstrup | 3.0 |
| Recruitment arrangements (for publication) | K2_Recuritment material Eboks BI_portal | 3.0 |
| Subject information and informed consent form (for publication) | L1_ICF | 1 |
| Subject information and informed consent form (for publication) | L1_ICF Tillg til samtykke hjerte-PET-CT | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF Tillg til samtykke Retten til ikke-viden | 1 |
| Subject information and informed consent form (for publication) | L1_ICF Tillg til samtykke vvsprve af fedtvv | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS_Del-studie_AUH | 1 |
| Subject information and informed consent form (for publication) | L1_SIS_Del-studie_RHG | 1 |
| Subject information and informed consent form (for publication) | L2_Dine rettigheder som forsgsperson i forsg med medicin | 1 |
| Subject information and informed consent form (for publication) | L2_Vejledning til opsamling af dgnurin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Kerendia | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Ozempic | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis 2025-522503-18-00 | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-06-09 | Denmark | Acceptable 2025-07-31
|
2025-09-09 |