Actively Recruiting
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
Led by Bayer · Updated on 2026-03-31
50000
Participants Needed
4
Research Sites
124 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 12 months of continuous medical and pharmacy coverage in the database before starting finerenone
- No prescription for finerenone in the 12 months before starting the study
- Age 18 years or older at the time of starting finerenone
- Evidence of type 2 diabetes at or before starting finerenone
- Chronic kidney disease stages 2, 3, or 4, defined by diagnosis codes or specific urine and blood test results before or at the start of finerenone treatment
You will not qualify if you...
- Kidney failure defined by two eGFR test results below 15 mL/min/1.73 m2 taken 90 to 540 days apart
- Dependence on dialysis with at least 3 sessions over 90 days during baseline
- Diagnosis code indicating kidney failure or chronic kidney disease stage 5
- History of kidney transplant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Many Locations
Multiple Locations, New Jersey, United States, 07981
Completed
2
Bayer
Berlin, Germany, 13353
Actively Recruiting
3
Many Locations
Multiple Locations, Japan
Completed
4
Many Locations
Multiple Locations, Taiwan
Completed
Research Team
B
Bayer Clinical Trials Contact
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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