NCT05703880

An Observational Study Called FIRST-2.0 to Learn More About the Use of the Study Treatment Finerenone Including How Safe it is and How Well it Works Under Real-world Conditions

Finerenone FIRST (Finerenone Research of Early Safety and Effectiveness), Part 2.0

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 15,948 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an observational study, in which data from people in the United States (US) 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 finerenone treatment as prescribed by their doctors. To do this, the researchers will collect data on: * general information of the participants such as age or gender * any other disease or medical condition in the participants * other medications used while taking finerenone. The researchers will also collect data on kidney function and possible heart problems to find out how well finerenone works. Additionally, medical problems possibly related to finerenone treatment will be collected to learn more about how safe finerenone is in real-world use. The data will come from US databases Optum Electronic Health Records (EHR) and OM1 Real-World Data Cloud (RWDC). They will cover the period from July 2021 to May 2023. Only already available data is collected and studied. There are no required visits or tests in this study.

Conditions

• Chronic Kidney Disease
• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Finerenone (Kerendia, BAY948862)	Retrospective cohort analysis using United States Optum EHR data and OM1 RWDC databases.

Timeline

• Start date: 2023-06-01
• Primary completion: 2024-10-01
• Completion: 2024-10-01
• First posted: 2023-01-30
• Last updated: 2024-10-18

Locations

2 sites across 1 country: United States