FINESSE-CKD

CompletedPhase 2

Optimizing Albuminuria Treatment in CKD With Finerenone and Semaglutide

Optimization of Albuminuria Lowering Therapies to Individual Patients With CKD Using FINErenone and SEmaglutide

Lead sponsor

University Medical Center Groningen

Asset

Semaglutide

Oral · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Chronic kidney disease

Eligibility highlights

•HbA1c 5.7-11%•eGFR 25-90•UACR ≥100

Primary endpoint

•≥30% reduction in urinary albumin:creatinine ratio (UACR) from baseline during

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07819227

Org study ID17456

Secondary ID2023

Secondary ID2023-506434-69-00

Timeline

Milestones

Study start2025-02-11actual

Primary completion2026-08-31actual

Study completion2026-08-31actual

Study first posted2026-09-14actual

Last update posted2026-09-28actual

Assets

Investigational agents

Semaglutide

Who this study enrolls

Chronic kidney disease

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•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

Exclusion criteria

•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

•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)

Endpoints (3)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Renal / kidney

Other (unclassified)

Renal / kidney

2 endpoints

Primary/protocol endpoint

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)

change from baseline, improvement

Secondary/protocol endpoint

Percentage change in UACR

Time frame:From baseline to end of study (week 37)

percent change from baseline, improvement

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Number of missed urine collection in the remote (@home) setting

Time frame:From baseline to end of study (Week 37)

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.