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.
Study Type
OBSERVATIONAL
Enrollment
15,948
Retrospective cohort analysis using United States Optum EHR data and OM1 RWDC databases.
OM1 Real-World Data Cloud (RWDC)
Boston, Massachusetts, United States
Optum electronic health records (EHR) database
Eden Prairie, Minnesota, United States
Descriptive summary of characteristics of patients who initiate finerenone and have CKD and T2D in the US.
Time frame: Up to 365 days
Descriptive summary of comorbidities of patients who initiate finerenone and have CKD and T2D in the US.
Time frame: Up to 365 days
Descriptive summary of comedications of patients who initiate finerenone and have CKD and T2D in the US.
Time frame: Up to 180 days
Incidence rate of composite renal outcomes
Time frame: Up to 18 months
Incidence rate of composite cardiovascular outcomes
Time frame: Up to 18 months
Number of patients who initiate finerenone using a 10 mg dose and number of patients who have up-titrated to a 20 mg dose by 1, 3, 6, and 12 months, respectively.
Time frame: Up to 18 months
Number of patients who initiate finerenone using a 20 mg dose and number of patients who have down-titrated to a 10 mg dose by 1, 3, 6, and 12 months, respectively
Time frame: Up to 18 months
Incidence rate of hyperkalemia
Time frame: Up to 18 months
Incidence of hospitalization associated with a hyperkalemia event
Time frame: Up to 18 months
Change in UACR between baseline, at 4 months and end of follow up visit after initiating finerenone
UACR: Urine Albumin to Creatinine Ratio
Time frame: Up to 18 months
Change in eGFR between baseline, at 4 months and end of follow up visit after initiating finerenone
eGFR: Estimated Glomerular Filtration Rate
Time frame: Up to 18 months
Change in level of serum potassium between baseline and end of follow up visit after initiating finerenone
Time frame: Up to 18 months
Incidence rates of the respective component outcomes of the CV and renal composite outcomes
Time frame: Up to 18 months
Incidence rate of proliferative diabetic retinopathy in patients who initiate finerenone with prior non-proliferative diabetic retinopathy
Proliferative diabetic retinopathy is identified by the occurrence of an inpatient or outpatient diagnosis code for proliferative diabetic retinopathy.
Time frame: Up to 18 months
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