An Observational Study, Called FINEXPLORER, to Learn More About How Well Finerenone Works in Adults in Spain With Chronic Kidney Disease (CKD) Linked to Type 2 Diabetes, by Looking at Changes in a CKD Risk Score (FINEXPLORER)

An Observational Prospective Study to Analyse Changes in the Klinrisk Chronic Kidney Disease Progression Model Score in a Cohort of Patients With CKD Associated With Type 2 Diabetes Treated With Finerenone in Spain

This is a prospective observational study in which data from people with chronic kidney disease (CKD) associated with type 2 diabetes (T2D) who will be receiving finerenone are collected and analyzed.

Chronic kidney disease (CKD) is common in people with type 2 diabetes. It can get worse over time and may lead to kidney failure and heart problems. Doctors often track kidney health using blood and urine tests, including the estimated glomerular filtration rate (eGFR) and the urine albumin-to-creatinine ratio (UACR). There are also tools that combine routine laboratory test results to estimate a person's risk of their kidney disease getting worse. One of these tools is called the Klinrisk model.

The study drug, finerenone, is already approved for doctors to prescribe to patients with CKD associated with T2D and albumin in the urine.

Finerenone works by blocking the mineralocorticoid receptor, a protein involved in inflammation and scarring in the kidneys and heart. The study drug, finerenone, is a non-steroidal mineralocorticoid receptor modulator that aims to reduce harmful kidney and heart changes.

The main purpose of this study is to determine whether the Klinrisk score improves after 2 years of treatment with finerenone in adults with CKD associated with T2D who are treated in routine care. To achieve this, researchers will collect data on:

• Clinical characteristics of participants, including their medical history related to CKD and T2D.
• Variables used to assess the CKD progression, such as eGFR, UACR, and Blood Urea Nitrogen (BUN).
• Participants' glucose, hemoglobin and potassium levels.

The study will also monitor any medical problems (known as adverse events) that participants may experience during the study. All adverse events will be recorded, regardless of whether they are related to the treatment.

Data will be collected from April 2026 to April 2029 and will cover a period of up to 24 months per participant. Data collection will occur over 5 visits that coincide with routine clinical care: inclusion, follow-up visits at 6, 12, and 18 months (±1 month), and a final visit at 24 months (±1 month).

Study Overview

• Status: Not yet recruiting
• Conditions: Type 2 Diabetes Mellitus; Chronic Kidney Disease
• Intervention / Treatment: Drug: Finerenone (Kerendia, BAY94-8862)

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Bayer Clinical Trials Contact; Phone Number: (+)1-888-84 22937; Email: clinical-trials-contact@bayer.com

Study Locations

• Spain
  • Multiple Locations, Spain
    • Many locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants with a diagnosed of CKD and T2D will be enrolled after the decision for treatment with finerenone has been made by the treating physician.

Description

Inclusion Criteria:

• Patients who sign the written informed consent to participate in the study.
• Men or women aged ≥18 years.
• Patients with CKD associated with type 2 diabetes and albuminuria (UACR >30 mg/g).
• Patients initiated on finerenone in routine clinical practice, according to the Summary of Product Characteristics (SmPC), within the 2 months prior to inclusion.

Exclusion Criteria:

• eGFR < 25 mL/min/1.73 m².
• Severe hepatic impairment.
• Clinical diagnosis of chronic heart failure with reduced ejection fraction (HFrEF) and persistent symptoms.
• Confirmed significant non-diabetic renal disease, including clinically relevant renal artery stenosis.
• Uncontrolled arterial hypertension (mean sitting systolic blood pressure [SBP] ≥160 mmHg or diastolic blood pressure [DBP] ≥100 mmHg at inclusion).
• Concomitant therapy with eplerenone, spironolactone, any renin inhibitor, or a potassium-sparing diuretic that has not been discontinued at least 4 weeks prior to inclusion.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participants diagnosed with CKD and T2D; Participants who are newly prescribed finerenone under routine treatment conditions.	Drug: Finerenone (Kerendia, BAY94-8862); Decision will be taken by the treating physician to initiate treatment with finerenone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of patients who show an improvement in the Klinrisk model score after 24 months of treatment with finerenone.	Up to 24 months from the beginning of treatment with finerenone.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients who show an improvement in the Klinrisk model score after 12 months of treatment with finerenone.		Up to 12 months from the beginning of treatment with finerenone.
Cumulative incidence (%) of the composite outcome of kidney failure, a sustained decrease of at least 40% in the eGFR from the beginning of treatment with finerenone (index date), or death from renal causes.		Up to 24 months from the beginning of treatment with finerenone.
Time to the composite endpoint of renal outcomes.	Composite outcome of kidney failure, a sustained decrease of at least 40% in the eGFR from the beginning of treatment with finerenone (index date), or death from renal causes.	Up to 24 months from the beginning of treatment with finerenone.
Cumulative incidence (%) for kidney failure.		Up to 24 months from the beginning of treatment with finerenone.
Cumulative incidence (%) for sustained decrease in eGFR to <15 mL/min/1.73 m2 maintained for at least 4 weeks.	eGFR = estimated glomerular filtration rate.	Up to 24 months from the beginning of treatment with finerenone.
Cumulative incidence (%) for sustained ≥40% eGFR decline from baseline maintained for at least 4 weeks.		Up to 24 months from the beginning of treatment with finerenone.
Cumulative incidence (%) of KRT.	KRT = kidney replacement therapy.	Up to 24 months from the beginning of treatment with finerenone.
Cumulative incidence (%) of death from renal causes.		Up to 24 months from the beginning of treatment with finerenone.
Change in UACR at months 6, 12, 18 and 24 (> 30%, 40% or >50%)	UACR = urinary albumin-to-creatinine ratio	At months 6, 12, 18 and 24.
Change in eGFR chronic slope at months 6, 12, 18 and 24.		At months 6, 12, 18 and 24.
Levels of NT-proBNP values.		Up to 24 months from the beginning of treatment with finerenone.
Cumulative incidence (%) of the composite outcome of death from CV causes, nonfatal myocardial infarction, nonfatal stroke or hospitalization for heart failure.		Up to 24 months from the beginning of treatment with finerenone.
Cumulative incidence (%) of death from CV causes.		Up to 24 months from the beginning of treatment with finerenone.
Cumulative incidence (%) of nonfatal myocardial infarction.		Up to 24 months from the beginning of treatment with finerenone.
Cumulative incidence (%) of nonfatal stroke.		Up to 24 months from the beginning of treatment with finerenone.
Cumulative incidence (%) of hospitalizations for heart failure.		Up to 24 months from the beginning of treatment with finerenone.
Incidence rate of death from CV causes.		Up to 24 months from the beginning of treatment with finerenone.
Incidence rate of nonfatal myocardial infarction.		Up to 24 months from the beginning of treatment with finerenone.
Incidence rate of nonfatal stroke.		Up to 24 months from the beginning of treatment with finerenone.
Incidence rate of hospitalization for heart failure.		Up to 24 months from the beginning of treatment with finerenone.
Number of adverse events (AEs) that occur during the study period.		Up to 30 days after the final treatment with finerenone.
Number of discontinuations of finerenone for AEs.		Up to 24 months from the beginning of treatment with finerenone.
Number of hospitalizations for AEs.		Up to 24 months from the beginning of treatment with finerenone.
Percentage of patients with hypokalemia, normokalemia and hyperkalemia.		Up to 24 months from the beginning of treatment with finerenone.
Percentage of patients who maintain normokalemia over the entire follow-up.	This endpoint will be analysed in patients with normokalemia at the start of finerenone.	Up to 24 months from the beginning of treatment with finerenone.
Incidence of acute kidney injury (AKI) requiring hospitalization.		Up to 24 months from the beginning of treatment with finerenone.

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Estimated): May 31, 2026
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): April 30, 2029

Study Registration Dates

• First Submitted: April 21, 2026
• First Submitted That Met QC Criteria: April 21, 2026
• First Posted (Actual): April 28, 2026

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Chronic Kidney Disease; Type 2 Diabetes Mellitus; Finerenone
• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Renal Insufficiency, Chronic; finerenone
• Other Study ID Numbers: 23098

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Currently, there is no established plan for the sharing of Individual Patient Data (IPD) from this study. The availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA 'Principles for responsible clinical trial data sharing.' This pertains to the scope, timepoint, and process of data access. As such, Bayer commits to considering requests from qualified researchers for patient- / study-level clinical trial data, and documents from clinical trials involving medicines and indications approved in the US and EU. However, this commitment does not reflect an active IPD sharing plan. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Researchers can use www.vivli.org to request access to IPD and documents from clinical studies to conduct research. Information on Bayer's criteria for listing studies is provided in the member section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No