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

Part of paid clinical trials in Multiple Locations, New Jersey.

Sponsor
Bayer
Study ID
NCT06278207
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
May 15, 2024
Status verified
Mar 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
50,000 participants (estimated)

Arms

  • Arm: Adult patients with CKD and T2D who initiate finerenone
    The data sources used include a network of commercial electronic health records (EHRs) and national claims data in Asia and in the United States.

Primary Outcome Measure

Participants' characteristics at baseline in a cohort of participants with CKD and T2D who initiate finerenone. [ Time Frame: 12 months before first prescription/dispensation of finerenone (index date) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Many LocationsMultiple LocationsNew Jersey07981-

Find similar trials in Multiple Locations, NJ

By condition
Chronic kidney diseaseType 2 diabetes
By specialty
NephrologyKidney diseaseEndocrinologyMetabolic healthWeight loss
By research site
Many Locations· Multiple Locations, NJ

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