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

NCT07554469 | Not Yet Recruiting

• 1 other identifier: 23098
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Chronic Kidney Disease; Type 2 Diabetes Mellitus

Keywords

Finerenone; Chronic Kidney Disease; Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (26)

• 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.

  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.

  Up to 24 months from the beginning of treatment with finerenone.

Study Arms (1)

Participants diagnosed with CKD and T2D

Participants who are newly prescribed finerenone under routine treatment conditions.

Drug: Finerenone (Kerendia, BAY94-8862)

Interventions

Finerenone (Kerendia, BAY94-8862) DRUG

Decision will be taken by the treating physician to initiate treatment with finerenone.

Participants diagnosed with CKD and T2D

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Many locations

Many Locations, Spain

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Diabetes Mellitus, Type 2

Interventions

finerenone

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; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Bayer Clinical Trials Contact

CONTACT

(+)1-888-84 22937; clinical-trials-contact@bayer.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: April 28, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): April 30, 2029
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)