RecruitingNCT06278207

An Observational Study Called FINEROD to Learn More About the Use of the Treatment Finerenone Including How Safe it is and How Well it Works Under Real-world Conditions

Finerenone Research of Outcomes and Drug Utilization


Sponsor

Bayer

Enrollment

50,000 participants

Start Date

May 15, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

This is an observational study, in which data from people in Asia and in the United States with chronic kidney disease (CKD) together with type 2 diabetes (T2D) are studied. The participants in this study are already receiving the study treatment finerenone as part of their regular care from their doctors. In observational studies, only observations are made without specified advice or interventions. CKD is a long-term progressive decrease in the kidneys' ability to work properly. In people with T2D, the body does not make enough of a hormone called insulin, or does not use insulin well enough. The resulting high blood sugar levels can cause damage to the kidneys. CKD often occurs together with T2D or as a consequence of T2D. Finerenone works by blocking certain proteins, called mineralocorticoid receptors. By doing this, it may reduce damage to kidneys, heart and blood vessels. Finerenone was recently approved in the US and is now available for doctors to prescribe to people with CKD together with T2D. Consequently, there is a need to collect more information about how finerenone is used, its safety and how well it works under real-world conditions. The main purpose of this study is to collect and describe the characteristics of people with CKD and T2D who are receiving initiate finerenone treatment as prescribed by their doctors. To do this, the researchers will collect general information of the participants such as age or gender and data on kidney function and possible heart problems. The researchers will also collect data on any other disease or medical condition in the participants and on other medications used while taking finerenone. The data will come from a network of commercial electronic health records (EHRs) and national claims data in the United States and in Asia. They cover the period from July 1st, 2021 until the latest data cut available for each dataset. Only already available data is collected and studied. There are no required visits or tests in this study.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study, called FINEROD, is observing how finerenone — a medication approved for people with both Type 2 diabetes and chronic kidney disease (CKD) — is used in the real world, outside of clinical trials. It looks at how safe it is and how well it works for actual patients. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with Type 2 diabetes - You have evidence of CKD Stages 2 to 4 - You have at least 12 months of continuous healthcare records available - You have not been prescribed finerenone in the year before starting it **You may NOT be eligible if...** - You have end-stage kidney failure (very low kidney function, on dialysis, or diagnosed with CKD Stage 5) - You have had a kidney transplant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFinerenone (BAY 94-8862)

10 mg or 20 mg daily


Locations(4)

Many Locations

Multiple Locations, New Jersey, United States

Bayer

Berlin, Germany

Many Locations

Multiple Locations, Japan

Many Locations

Multiple Locations, Taiwan

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NCT06278207


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