This is a post-authorization safety study (PASS) to describe the real-world use of finerenone in patients with chronic kidney disease (CKD) and type 2 diabetes mellitus (T2D) in China. The study will examine baseline characteristics, comorbidities, and comedications of patients who initiate finerenone treatment. It will also evaluate changes in kidney function markers including estimated glomerular filtration rate (eGFR), urinary albumin-to-creatinine ratio (UACR), and serum potassium levels over time. The study will assess hyperkalemia incidence, hospitalization rates associated with hyperkalemia, and finerenone dose titration patterns. This retrospective observational cohort study uses data from the Tianjin Healthcare and Medical Big Data Platform covering approximately 15 million residents. The study aims to provide evidence on finerenone safety and effectiveness in routine clinical practice in China, complementing data from controlled clinical trials. Results will inform healthcare providers about real-world finerenone use patterns and outcomes in Chinese patients with diabetic kidney disease.
Study Type
OBSERVATIONAL
Enrollment
5,000
Retrospective cohort analysis using the EHR data from the Tianjin Healthcare and Medical Big Data Platform (China) database.
Inspur Tianjin Regional Electronic Health Records Database
Tianjin, Tianjin Municipality, China
Descriptive summary of characteristics of patients who initiate finerenone and have CKD and T2D in China.
Time frame: Up to 365 days
Descriptive summary of comorbidities of patients who initiate finerenone and have CKD and T2D in China.
Time frame: Up to 365 days
Descriptive summary of comedications of patients who initiate finerenone and have CKD and T2D in China.
Time frame: Up to 180 days
To describe the routine monitoring of UACR, eGFR, and serum potassium before and after initiating finerenone in patients with CKD and T2D
Time frame: Up to 32 months
To describe the absolute levels and relative changes over time of UACR, eGFR, and serum potassium after initiating finerenone in patients with CKD and T2D
Time frame: Up to 32 months
To describe the incidence of hyperkalemia and the incidence of hospitalization associated with a hyperkalemia event after initiating finerenone in patients with CKD and T2D
Time frame: Up to 32 months
To describe the number of patients who initiate finerenone using a 10 mg dose and the proportion of patients who have up-titrated to a 20 mg dose by 1, 3, 6, and 12 months, respectively, depending on data availability
Time frame: Up to 32 months
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