An Observational Study Called FIRST-2.0 China to Learn More About the Use of the Study Treatment Finerenone Including How Safe it is and How Well it Works Under Real-world Conditions in a Chinese Population.

Sponsor
Bayer
Study ID
NCT07124039
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Finerenone (Kerendia, BAY948862) — DRUG
    Retrospective cohort analysis using the EHR data from the Tianjin Healthcare and Medical Big Data Platform (China) database.

Study Details

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.

Key Dates

Start date
Jul 16, 2025
Status verified
Apr 2026
Primary completion
Feb 28, 2026
Completion
Feb 28, 2026

Study Design

Enrollment
6,537 participants (actual)

Arms

  • Arm: Finerenone users
    Patients with chronic kidney disease and type 2 diabetes mellitus from China who initiate finerenone treatment.

Primary Outcome Measure

Descriptive summary of characteristics of patients who initiate finerenone and have CKD and T2D in China. [ Time Frame: Up to 365 days ]

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