Chronic Kidney DiseasePhase 2FINESSE-CKDNCT07819227
Optimizing Albuminuria Treatment in CKD With Finerenone and Semaglutide
A Phase 2 study testing Finerenone (BAY 94-8862), Semaglutide 14 MG [Rybelsus] and Finerenone and Semaglutide in people with Chronic Kidney Disease, run by University Medical Center Groningen at 6 sites in 4 countries.
Trial summary
The FINESSE-CKD trial investigates a personalized approach to the treatment of chronic kidney disease (CKD) by comparing the effects of finerenone and semaglutide on albuminuria. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Finerenone (BAY 94-8862), Semaglutide 14 MG [Rybelsus] and Finerenone and Semaglutide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 6 sitesin 4 countries
- Study dates
- 11 Feb 2025to 31 Aug 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Urinary albumin to creatinine ratio ≥100 mg/g and ≤3500 mg/g
- eGFR ≥25 and ≤90 mL/min/1.73m2
- HbA1c ≥5.7 and ≤11%
- On a stable dose of an ACEi/ARB for at least 4 weeks if tolerated
- On a stable dose of a SGLT2 inhibitor for at least 4 weeks if tolerated
- Willing to sign an informed consent
Who cannot join
- Diagnosis of type 1 diabetes
- Heart Failure with reduced ejection fraction and NYHA Class II to IV
- Acute coronary syndrome event within 6 months
- Serum potassium > 5.0 mmol/L
- Evidence of severe hepatic impairment determined by any one of: ALT or AST values exceeding 3x ULN, a history of hepatic encephalopathy, a history of oesophageal varices, or a history of portocaval shunt;
- Active pregnancy or breastfeeding
Show all 30Show fewer
- History of kidney or liver transplant
- Active malignancy
- Suggestive evidence of adrenal insufficiency
- History of chronic pancreatitis or idiopathic acute pancreatitis
- Personal or family history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma
- Personal history of non-familial medullary thyroid carcinoma
- History of severe hypersensitivity or contraindications to any MRA or GLP-1 RA
- Uncontrolled arterial hypertension (mean sitting systolic blood pressure (SBP) ≥180 mmHg or diastolic blood pressure (DBP) ≥110 mmHg)
- Any medication, surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of medications including, but not limited to any of the following:
- History of active inflammatory bowel disease within the 6 months;
- Major gastrointestinal tract surgery as determined by the physician;
- Pancreatitis within 6 months.
- GI ulcers and/or bleeding within 6 months;
- Evidence of urinary obstruction or difficulty in voiding at screening.
- Use of any of the following medications: CYP3A4 inhibitors, potassium sparing medications, trimethoprim, trimethoprim/sulfamethoxazole, GLP-1 RAs, and potassium supplements.
- Participation in any clinical trial within 3 months prior to initial dosing.
- Donation or loss of ≧400 ml blood within 8 weeks prior to initial dosing.
- History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by the laboratory assays conducted during the screening or according to investigator's assessment.
- History of noncompliance to medical regimens or unwillingness to comply with the study protocol.
- Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study.
- Women of childbearing potential (WOCBP):15
- WOCBP who are unwilling or unable to use an acceptable method of contraception to avoid pregnancy throughout the study and for up to 8 weeks after the last dose of study drug in such a manner the risk of pregnancy is minimized.
- WOCBP must have a negative serum or urine pregnancy test result (minimum sensitivity 25 IU/L or equivalent of HCG) at screening.
- Vulnerable (i.e. under guardianship) or mentally incapacitated subjects (i.e. not able to understand and sign the informed consent)
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
Spain2 sites
Hospital Vall d'Hebron
Barcelona
Hospital University Clinica Incliva
Valencia
About this study
Official title: Optimization of Albuminuria Lowering Therapies to Individual Patients With CKD Using FINErenone and SEmaglutide
The FINESSE-CKD trial investigates a personalized approach to the treatment of chronic kidney disease (CKD) by comparing the effects of finerenone and semaglutide on albuminuria. Approximately 36 participants will receive both treatments in a randomized crossover design, with the aim of identifying which treatment provides the greatest individual reduction in albuminuria. The primary objective is to determine whether a reduction of at least 30% in albuminuria can be achieved. The study will also assess the effect of combining both treatments and the feasibility of remotely monitoring treatment response through home measurements and urine collections. The total study duration is approximately 40 weeks.
Read the detailed description
The FINESSE-CKD trial investigates whether treatment for chronic kidney disease (CKD) can be personalized based on an individual patient's response to finerenone and semaglutide. Although both treatments have been shown to reduce albuminuria and improve kidney and cardiovascular outcomes in relevant patient populations, treatment response can vary considerably between individuals. The study therefore aims to identify whether selecting the treatment that provides the greatest reduction in albuminuria for each individual patient can achieve a clinically relevant reduction of at least 30% in urinary albumin-to-creatinine ratio (UACR).
This is a randomized, open-label, crossover, multicenter, decentralized clinical trial. Participants will receive finerenone and semaglutide according to the study treatment schedule, allowing the response to each treatment to be assessed within the same individual. The study will also evaluate whether combined treatment with finerenone and semaglutide provides additional albuminuria lowering compared with the individually selected treatment.
A decentralized approach will be used to reduce the need for hospital visits and assess the feasibility of monitoring treatment response remotely. Participants will perform selected measurements and urine collections at home, including monitoring of body weight and blood pressure.
The primary outcome is the proportion of participants achieving a ≥30% reduction in UACR. Secondary outcomes include the percentage change in UACR from baseline and the feasibility of remote urine collection. The study is expected to provide insight into whether an individualized treatment strategy can improve the effectiveness of albuminuria-lowering therapy while reducing unnecessary treatment and patient burden.
- Conditions
- Chronic Kidney Disease
- Being tested
- Finerenone (BAY 94-8862), Semaglutide 14 MG [Rybelsus], Finerenone and Semaglutide
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Finerenone (BAY 94-8862)Drug
The dose of oral finerenone is 20 mg/day (up-titrate from 10 mg/day in patients with an eGFR <60 mL/min/1.73m2 (up-titrate from 10 mg/day in patients with an eGFR <60 mL/min/1.73m2). Dose modifications in case of occurrence of side-effects will be carried out according to the investigator's discretion. oral film-coated tablet.
Semaglutide 14 MG [Rybelsus]Drug
14 mg once daily (registered maximum dose, up-titrate from 3 mg and 7 mg once daily). Dose modifications in case of occurrence of side-effects will be carried out according to the investigator's discretion. Oral tablet.
Finerenone and SemaglutideDrug
After 4 weeks of maximum tolerated semaglutide, participants will receive combined oral finerenone and semaglutide for 6 weeks. The procedures during the 6 weeks treatment period are the same as those during the finerenone only treatment periods. Because the combination treatment period immediately follows the semaglutide monotherapy treatment period, no additional titration of semaglutide is necessary. During the combination treatment period, the dose of finerenone will be uptitrated after 2 weeks in patients with eGFR ≥60 mL/min/1.73m2 and serum potassium ≤5.0 mmol/L.
| Study group | Role | What they receive |
|---|---|---|
| Finerenone (monotherapy) first | Experimental | 6 weeks finerenone monotherapy → 6-week wash-out → 12 weeks semaglutide monotherapy → 6 weeks finerenone + semaglutide combination therapy → 6-week wash-out. Receives: Drug: Finerenone (BAY 94-8862); Drug: Semaglutide 14 MG [Rybelsus]; Drug: Finerenone and Semaglutide |
| Semaglutide (monotherapy) first | Experimental | 12 weeks semaglutide monotherapy → 6 weeks finerenone + semaglutide combination therapy → 6-week wash-out → 6 weeks finerenone monotherapy → 6-week wash-out. Receives: Drug: Finerenone (BAY 94-8862); Drug: Semaglutide 14 MG [Rybelsus]; Drug: Finerenone and Semaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with ≥30% reduction in urinary albumin:creatinine ratio (UACR) from baseline during monotherapy with finerenone or semaglutide or combined treatment with finerenone-semaglutide.
Measured: From baseline to the end of study (Week 37)
Secondary outcomes (2)
Percentage change in UACR
Measured: From baseline to end of study (week 37)
Number of missed urine collection in the remote (@home) setting
Measured: From baseline to end of study (Week 37)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start11 Feb 2025
- Primary completion31 Aug 2026
- Study completion31 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a randomized, open-label, cross-over, multicenter, decentralized clinical trial.
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07819227
- Sponsor's protocol ID
- 17456
- Other IDs
- 2023-506434-69-00, 2023
- Acronym
- FINESSE-CKD
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Albuminuria Lowering Therapies to Individual Patients With CKD Using FINErenone and SEmaglutide
- ClinicalTrials.gov ID
- NCT07819227
- Acronym / sponsor ID
- FINESSE-CKD / 17456
- Conditions
- Chronic Kidney Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 11 Feb 2025 (actual)
- Primary completion
- 31 Aug 2026 (actual)
- Study completion
- 31 Aug 2026 (actual)
- First posted
- 14 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The FINESSE-CKD trial investigates a personalized approach to the treatment of chronic kidney disease (CKD) by comparing the effects of finerenone and semaglutide on albuminuria. Approximately 36 participants will receive both treatments in a randomized crossover design, with the aim of identifying which treatment provides the greatest individual reduction in albuminuria. The primary objective is to determine whether a reduction of at least 30% in albuminuria can be achieved. The study will also assess the effect of combining both treatments and the feasibility of remotely monitoring treatment response through home measurements and urine collections. The total study duration is approximately 40 weeks.
Detailed description
The FINESSE-CKD trial investigates whether treatment for chronic kidney disease (CKD) can be personalized based on an individual patient's response to finerenone and semaglutide. Although both treatments have been shown to reduce albuminuria and improve kidney and cardiovascular outcomes in relevant patient populations, treatment response can vary considerably between individuals. The study therefore aims to identify whether selecting the treatment that provides the greatest reduction in albuminuria for each individual patient can achieve a clinically relevant reduction of at least 30% in urinary albumin-to-creatinine ratio (UACR).
This is a randomized, open-label, crossover, multicenter, decentralized clinical trial. Participants will receive finerenone and semaglutide according to the study treatment schedule, allowing the response to each treatment to be assessed within the same individual. The study will also evaluate whether combined treatment with finerenone and semaglutide provides additional albuminuria lowering compared with the individually selected treatment.
A decentralized approach will be used to reduce the need for hospital visits and assess the feasibility of monitoring treatment response remotely. Participants will perform selected measurements and urine collections at home, including monitoring of body weight and blood pressure.
The primary outcome is the proportion of participants achieving a ≥30% reduction in UACR. Secondary outcomes include the percentage change in UACR from baseline and the feasibility of remote urine collection. The study is expected to provide insight into whether an individualized treatment strategy can improve the effectiveness of albuminuria-lowering therapy while reducing unnecessary treatment and patient burden.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomized, open-label, cross-over, multicenter, decentralized clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Finerenone (monotherapy) first | Experimental | Drug: Finerenone (BAY 94-8862), Drug: Semaglutide 14 MG [Rybelsus], Drug: Finerenone and Semaglutide6 weeks finerenone monotherapy → 6-week wash-out → 12 weeks semaglutide monotherapy → 6 weeks finerenone + semaglutide combination therapy → 6-week wash-out. |
| Semaglutide (monotherapy) first | Experimental | Drug: Finerenone (BAY 94-8862), Drug: Semaglutide 14 MG [Rybelsus], Drug: Finerenone and Semaglutide12 weeks semaglutide monotherapy → 6 weeks finerenone + semaglutide combination therapy → 6-week wash-out → 6 weeks finerenone monotherapy → 6-week wash-out. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 years
- Urinary albumin to creatinine ratio ≥100 mg/g and ≤3500 mg/g
- eGFR ≥25 and ≤90 mL/min/1.73m2
- HbA1c ≥5.7 and ≤11%
- On a stable dose of an ACEi/ARB for at least 4 weeks if tolerated
Key exclusion criteria (30 listed)
- Diagnosis of type 1 diabetes
- Heart Failure with reduced ejection fraction and NYHA Class II to IV
- Acute coronary syndrome event within 6 months
- Serum potassium > 5.0 mmol/L
- Evidence of severe hepatic impairment determined by any one of: ALT or AST values exceeding 3x ULN, a history of hepatic encephalopathy, a history of oesophageal varices, or a history of portocaval shunt;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Finerenone (BAY 94-8862)The dose of oral finerenone is 20 mg/day (up-titrate from 10 mg/day in patients with an eGFR <60 mL/min/1.73m2 (up-titrate from 10 mg/day in patients with an eGFR <60 mL/min/1.73m2). Dose modifications in case of occurrence of side-effects will be carried out according to the investigator's discretion. oral film-coated tablet. | Drug | Finerenone (monotherapy) first, Semaglutide (monotherapy) first |
| Semaglutide 14 MG [Rybelsus]14 mg once daily (registered maximum dose, up-titrate from 3 mg and 7 mg once daily). Dose modifications in case of occurrence of side-effects will be carried out according to the investigator's discretion. Oral tablet. | Drug | Finerenone (monotherapy) first, Semaglutide (monotherapy) first |
| Finerenone and SemaglutideAfter 4 weeks of maximum tolerated semaglutide, participants will receive combined oral finerenone and semaglutide for 6 weeks. The procedures during the 6 weeks treatment period are the same as those during the finerenone only treatment periods. Because the combination treatment period immediately follows the semaglutide monotherapy treatment period, no additional titration of semaglutide is necessary. During the combination treatment period, the dose of finerenone will be uptitrated after 2 weeks in patients with eGFR ≥60 mL/min/1.73m2 and serum potassium ≤5.0 mmol/L. | Drug | Finerenone (monotherapy) first, Semaglutide (monotherapy) first |
Primary outcome
Proportion of patients with ≥30% reduction in urinary albumin:creatinine ratio (UACR) from baseline during monotherapy with finerenone or semaglutide or combined treatment with finerenone-semaglutide.
Time frame: From baseline to the end of study (Week 37)
2 secondary outcomes
Percentage change in UACR
Time frame: From baseline to end of study (week 37)
Number of missed urine collection in the remote (@home) setting
Time frame: From baseline to end of study (Week 37)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Chronic Kidney Disease
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Finerenone (BAY 94-8862), Semaglutide 14 MG [Rybelsus] and Finerenone and Semaglutide in people with Chronic Kidney Disease, run by University Medical Center Groningen at 6 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Italy, Spain, Denmark, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with ≥30% reduction in urinary albumin:creatinine ratio (UACR) from baseline during monotherapy with finerenone or semaglutide or combined treatment with finerenone-semaglutide. (time frame: From baseline to the end of study (Week 37)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.