An Observational Study to Learn More About How Safe Finerenone is and How Well it Works in People With Chronic Kidney Disease and Type 2 Diabetes in Routine Medical Care in the United States
NCT ID: NCT06608212
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
150000 participants
OBSERVATIONAL
2024-10-09
2025-12-31
Brief Summary
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In observational studies, only observations are made without participants receiving any advice or any changes to healthcare.
CKD is a long-term condition in which the kidneys' ability to work properly gradually decreases over time. It is common in people with Type 2 diabetes mellitus (T2D), a condition in which glucose levels rise in the blood. People who have T2D and CKD may also develop heart disease over time.
The study drug, finerenone, is already approved for doctors to prescribe to people with CKD and T2D in the US. It blocks the activity of a protein involved in worsening kidney function.
The participants in this study are allowed to take finerenone as part of their regular care from their doctors.
The main purpose of the study is to learn about how safe finerenone is and how well it works in people with CKD and T2D in routine medical care. To do this, researchers will collect information about the time to first occurrence of any of the following heart-related problems for participants in the US who are taking finerenone and those who are not taking it:
* Heart attacks
* Hospitalization due to heart failure The data will come from the electronic healthcare records of people with CKD and T2D in the US who are allowed to take finerenone after July 2021.
Researchers will track participants' data and will follow them until the occurrence of heart-related problems, the participant's data is no longer available, there is a change in the participant's treatment strategy, or the end of the study.
In this study, only available data from routine care are collected. No visits or tests are required as part of this study.
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Finerenone group
Patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) initiating finerenone. Retrospective analysis using secondary data collection from existing healthcare data from the US. Considered data sources include the HealthVerity Chronic Kidney Disease Masterset
Finerenone (Kerendia, BAY948862)
Follow clinical practice/administration.
Comparator group
Patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) not using finerenone. Retrospective analysis using secondary data collection from existing healthcare data from the US. Considered data sources include the HealthVerity Chronic Kidney Disease Masterset
Others except finerenone
Follow clinical practice/administration. The non-use finerenone treatment strategy will require individuals to be free of finerenone use.
Interventions
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Finerenone (Kerendia, BAY948862)
Follow clinical practice/administration.
Others except finerenone
Follow clinical practice/administration. The non-use finerenone treatment strategy will require individuals to be free of finerenone use.
Eligibility Criteria
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Inclusion Criteria
* No recorded use of finerenone before Time 0 (days \[-all available, 0\])
* Aged 18 years or older on Time 0
* Diagnosis of T2D at any time on or before Time 0 (days \[-all available, 0\])
* Having a diagnosis code indicating CKD stage 1, 2, 3, 4, or stage unspecified on or before Time 0 (days \[-all available, 0\])
Exclusion Criteria
* Type 1 diabetes (T1D) at any time on or before Time
* Evidence of end-stage kidney disease (ESKD) at any time on or before Time 0
* A diagnosis of kidney cancer at any time on or before Time 0
* A diagnosis of adrenal insufficiency at any time on or before Time 0
* Evidence of hepatic impairment at any time on or before Time 0
* An eGFR measurement \< 25 mL/min/1.73 m2 on or in the 90 days before Time 0
* Evidence of recent increased serum potassium or hyperkalaemia
* Use of a strong CYP3A4 inhibitor on or in the 183 days before Time 0
* Evidence of pregnancy measured on or in the 40 weeks before Time 0
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Locations
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Bayer
Whippany, New Jersey, United States
Countries
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Related Links
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Other Identifiers
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22663
Identifier Type: -
Identifier Source: org_study_id