Not Yet Recruiting

Chronic Kidney Disease, Type 2 Diabetes Mellitus

Bayer Identifier:

23098

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

Not Available

EU CT Number:

Not Available

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

Trial purpose

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).

Key Participants Requirements

Sex

All

Age

18 - N/A

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.

Trial summary

Enrollment Goal

500

Trial Dates

April 2026 - April 2029

Phase

Phase 4

Could I Receive a placebo

Products

Kerendia (Finerenone, BAY94-8862)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
	Many locations	Many locations, Spain

Primary Outcome

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

Secondary Outcome

Percentage of patients who show an improvement in the Klinrisk model score after 12 months of treatment with finerenone.
Time Frame:
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.
Time Frame:
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.
Time Frame:
Up to 24 months from the beginning of treatment with finerenone.
Cumulative incidence (%) for kidney failure.
Time Frame:
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.
Time Frame:
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.
Time Frame:
Up to 24 months from the beginning of treatment with finerenone.
Cumulative incidence (%) of KRT.
KRT = kidney replacement therapy.
Time Frame:
Up to 24 months from the beginning of treatment with finerenone.
Cumulative incidence (%) of death from renal causes.
Time Frame:
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
Time Frame:
At months 6, 12, 18 and 24.
Change in eGFR chronic slope at months 6, 12, 18 and 24.
Time Frame:
At months 6, 12, 18 and 24.
Levels of NT-proBNP values.
Time Frame:
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.
Time Frame:
Up to 24 months from the beginning of treatment with finerenone.
Cumulative incidence (%) of death from CV causes.
Time Frame:
Up to 24 months from the beginning of treatment with finerenone.
Cumulative incidence (%) of nonfatal myocardial infarction.
Time Frame:
Up to 24 months from the beginning of treatment with finerenone.
Cumulative incidence (%) of nonfatal stroke.
Time Frame:
Up to 24 months from the beginning of treatment with finerenone.
Cumulative incidence (%) of hospitalizations for heart failure.
Time Frame:
Up to 24 months from the beginning of treatment with finerenone.
Incidence rate of death from CV causes.
Time Frame:
Up to 24 months from the beginning of treatment with finerenone.
Incidence rate of nonfatal myocardial infarction.
Time Frame:
Up to 24 months from the beginning of treatment with finerenone.
Incidence rate of nonfatal stroke.
Time Frame:
Up to 24 months from the beginning of treatment with finerenone.
Incidence rate of hospitalization for heart failure.
Time Frame:
Up to 24 months from the beginning of treatment with finerenone.
Number of adverse events (AEs) that occur during the study period.
Time Frame:
Up to 30 days after the final treatment with finerenone.
Number of discontinuations of finerenone for AEs.
Time Frame:
Up to 24 months from the beginning of treatment with finerenone.
Number of hospitalizations for AEs.
Time Frame:
Up to 24 months from the beginning of treatment with finerenone.
Percentage of patients with hypokalemia, normokalemia and hyperkalemia.
Time Frame:
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.
Time Frame:
Up to 24 months from the beginning of treatment with finerenone.
Incidence of acute kidney injury (AKI) requiring hospitalization.
Time Frame:
Up to 24 months from the beginning of treatment with finerenone.

Trial design

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

Trial Type

Observational

Intervention Type

Drug

Trial Purpose

N/A

Allocation

N/A

Blinding

N/A

Assignment

N/A

Trial Arms

N/A

Additional Information

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