Optimizing Albuminuria Treatment in CKD With Finerenone and Semaglutide

NCT07819227 | Completed Phase 2

• 3 other identifiers: 174562023-506434-69-002023
• Study Type: interventional
• Target: 41
• Locations: 4 countries
• Sites: 6

Brief 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. 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.

Conditions

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  From baseline to the end of study (Week 37)

Secondary Outcomes (2)

• Percentage change in UACR

  From baseline to end of study (week 37)

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

  From baseline to end of study (Week 37)

Study Arms (2)

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.

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.

Drug: Finerenone (BAY 94-8862); Drug: Semaglutide 14 MG [Rybelsus]; Drug: Finerenone and Semaglutide

Interventions

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.

Finerenone (monotherapy) first; Semaglutide (monotherapy) first

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 (monotherapy) first; Semaglutide (monotherapy) first

Finerenone and Semaglutide DRUG

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.

Finerenone (monotherapy) first; Semaglutide (monotherapy) first

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (6)

Steno Diabetes Center

Copenhagen, Denmark

Location

University of Calabria

Cosenza, Italy

Location

University of Campania

Naples, Italy

Location

Ziekenhuisgroep Twente

Almelo, Netherlands

Location

Hospital Vall d'Hebron

Barcelona, Spain

Location

Hospital University Clinica Incliva

Valencia, Spain

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

finerenone; semaglutide

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized, open-label, cross-over, multicenter, decentralized clinical trial.

Study Record Dates

• First Submitted: September 8, 2026
• First Posted: September 14, 2026
• Study Start: February 11, 2025
• Primary Completion: August 31, 2026
• Study Completion: August 31, 2026
• Last Updated: September 28, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2); NL (1); DK (1); IT (2)