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.
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.
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
Adult patients with chronic kidney disease and type 2 diabetes who initiate finerenone in secondary data sources (electronic health records (EHR) and claims data) in the United States and in Asia.
Cohort
Retrospective
Finerenone (BAY 94-8862)
Drug10 mg or 20 mg daily
Participants' characteristics at baseline in a cohort of participants with CKD and T2D who initiate finerenone.
Sociodemographic characteristics such as age, sex, race and socio-economic status.
Participants' comorbidities at baseline in a cohort of participants with CKD and T2D who initiate finerenone.
Including heart diseases, lipid diseases, liver disease, hospitalization for acute kidney injury, dementia, body mass index, smoking status, alcohol abuse, and other comorbidities measured using comorbidities indexes (such as the Charlson comorbidity index)
Participants' comedications at baseline in a cohort of participants with CKD and T2D who initiate finerenone.
In subcohorts of participants in co-medication between finerenone and other hypertensive and diabetic medications (SGLT2i, RAASi, GLP-1 RA, etc.), characterized by CKD stage, including a 15-25 ml/min/1.73 m2 eGFR subgroup.
Proportion of finerenone initiators with and without UACR measurements at baseline
UACR=Urinary Albumin-to-Creatinine Ratio
Average UACR in the subcohort with UACR measurements
Incidence rate of kidney failure in participants with CKD and T2D that initiate finerenone.
Any of the following: ≥ 2 outpatient eGFR measurements of \< 15 mL/min/1.73 m2 separated by at least 90 days; Record of dependence on dialysis (at least 3 sessions over at least 90 days); Diagnosis records of kidney failure or CKD stage 5; Record of kidney transplant
Incidence rate of a composite cardiovascular outcome in participants with CKD and T2D that initiate finerenone.
Acute myocardial infarction, identified as an inpatient hospital diagnosis of fatal or non-fatal acute myocardial infarction. Congestive heart failure, identified as an impatient hospital or emergency department diagnosis of heart failure and stratified by new-onset or recurrent heart failure.
