Finerenone for Chronic Kidney Disease and Type 2 Diabetes
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
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
50,000 (estimated)
Sponsor
Bayer · Industry
Who this trial is looking for
This trial is looking for people with chronic kidney disease and type 2 diabetes who are already receiving finerenone as part of their regular treatment. Participants will have their general health information and kidney function monitored over time.
Are You a Good Fit for This Trial?
Must be takingFinerenone
You may be able to join if
I am 18 years or older
I have type 2 diabetes
I have been receiving medical care continuously for at least the last 12 months
I have not taken finerenone in the past 12 months
I have chronic kidney disease stage 2, 3, or 4
You may not be able to join if
I have kidney failure
I am dependent on dialysis
I have been diagnosed with kidney failure or stage 5 chronic kidney disease
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 interventio…
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.
Trial Locations
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Eligibility Criteria
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 fine…
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
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