Actively Recruiting
Finerenone Research of Outcomes and Drug Utilization An Observational Study of Finerenone Use and Safety in People with Chronic Kidney Disease and Type 2 Diabetes
Led by Bayer · Updated on 2026-03-31
50000
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying people in Asia and the United States who have chronic kidney disease (CKD) along with type 2 diabetes (T2D). The study focuses on individuals who are already taking the drug finerenone as part of their regular medical care. This observational study aims to collect detailed information about these patients, including their kidney function, heart health, other medical conditions, and medications, without changing their treatment or requiring extra tests or visits. The study gathers data from commercial electronic health records and national claims databases covering the period from July 2021 onward. It observes patients who have started finerenone at doses of 10 mg or 20 mg daily, tracking how the drug is used in real-world settings. Researchers will analyze medication patterns, kidney and heart outcomes, and dose changes over time, up to a follow-up period that could last over 12 years. Participants do not need to attend specific study visits or undergo additional procedures. The study collects existing medical information from records to describe patient characteristics before starting finerenone and monitor health outcomes afterward. Key measurements include kidney function tests, urine albumin levels, heart-related events, and medication use. The study helps understand the safety and use of finerenone in everyday clinical practice over time.
CONDITIONS
Brief 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 care enrollment 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
- Diagnosis of type 2 diabetes at or before starting finerenone
- Chronic kidney disease stages 2 to 4 confirmed by diagnosis codes or specific kidney test results before starting finerenone
You will not qualify if you...
- Kidney failure defined by two eGFR test results less than 15 mL/min/1.73 m2 separated by 90 to 540 days
- Dependence on dialysis with at least 3 sessions over 90 days during baseline period
- Diagnosis of 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 150 months
Participants who initiate finerenone are observed to learn about the drug's safety and how well it works under real-world conditions.
Visits and data collection occur as part of routine healthcare and electronic health records monitoring
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
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here