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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:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants diagnosed with CKD and T2D | Participants who are newly prescribed finerenone under routine treatment conditions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Finerenone (Kerendia, BAY94-8862) | Drug | Decision will be taken by the treating physician to initiate treatment with finerenone. |
|
| Measure | Description | 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bayer Clinical Trials Contact | Contact | (+)1-888-84 22937 | clinical-trials-contact@bayer.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many locations | Recruiting | Multiple Locations | Spain |
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.
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| 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. |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C576501 | finerenone |
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