NCT06278207 · Bayer
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
(FINEROD)
What this study 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.
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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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- A minimum of 12 months of continuous enrolment in the databases with medical and pharmacy coverage measured as continuously receiving medical care from health providers contributing to the EHR or claims system, depending on the database used
- No recorded prescription for finerenone in the 12 months prior to the index date
- Age of 18 years or older as of the index date
- Evidence of T2D at any point before (and including) the index date.
- CKD stages 2-4 related to eligibility will be defined according to the presence of the following criteria at any point before (and including) the index date:
- A diagnosis code indicating CKD stage 2, 3, 4 or stage unspecified
- two UACR tests results ≥ 30 mg/g separated by at least 90 days and by not more than 540 days
- two different eGFR test results ≥ 15 mL/min/1.73 m2 AND \< 60 mL/min/1.73 m2 separated by at least 90 days and by not more than 540 days
Exclusion criteria
- \- Kidney failure defined as follows:
- Two different eGFR test results \< 15 mL/min/1.73 m2 separated by at least 90 days and by not more than 540 days;
- Dependence on dialysis (at least 3 sessions over at least 90 days during the baseline period);
- A diagnosis code indicating kidney failure or CKD stage 5; Kidney transplant
Where
- Multiple Locations, New Jersey
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 18, 2026 · Source of record for eligibility and locations