Inspur Tianjin Regional Electronic Health Records Database
Tianjin, Tianjin Municipality, 301799, China
NCT Number: NCT07124039
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.
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Notify Me18 year and older
All sexes
Observational
Tianjin, Tianjin Municipality, 301799, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
OR
Exclusion criteria
Retrospective cohort analysis using the EHR data from the Tianjin Healthcare and Medical Big Data Platform (China) database.
Time frame: Up to 365 days
Time frame: Up to 365 days
Time frame: Up to 180 days
Time frame: Up to 32 months
Time frame: Up to 32 months
Time frame: Up to 32 months
Time frame: Up to 32 months
Time frame: Up to 32 months
In patients with CKD and T2D in sub-cohorts of patients stratified by baseline UACR level (<30 mg/g, 30-300 mg/g, >300 mg/g), depending on data availability
Time frame: Up to 32 months
In patients with CKD and T2D in sub-cohorts of patients stratified by baseline UACR level (<30 mg/g, 30-300 mg/g, >300 mg/g), depending on data availability
Time frame: Up to 32 months
In patients with CKD and T2D in sub-cohorts of patients stratified by baseline UACR and eGFR level (e.g., UACR ≥30 mg/g with eGFR <60 mL/min/1.73m2, UACR ≥30 mg/g with eGFR ≥60 mL/min/1.73m2, UACR <30 mg/g with eGFR <60 mL/min/1.73m2), depending on data availability
Time frame: Up to 32 months
In patients with CKD and T2D who initiate finerenone, depending on data availability. Frequency of finerenone use during follow-up, dosing regimen, treatment discontinuation, treatment duration, and treatment persistence will be assessed based on data availability
Bayer
Industry
FIRST-2.0 China: Finerenone FIRST (Finerenone Research of Early Safety and Effectiveness), Part 2.0 in China
Acronym: FIRST-2_CN
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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