Trials / Completed
CompletedNCT07124039
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.
FIRST-2.0 China: Finerenone FIRST (Finerenone Research of Early Safety and Effectiveness), Part 2.0 in China
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 6,537 (actual)
- Sponsor
- Bayer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Finerenone (Kerendia, BAY948862) | Retrospective cohort analysis using the EHR data from the Tianjin Healthcare and Medical Big Data Platform (China) database. |
Timeline
- Start date
- 2025-07-16
- Primary completion
- 2026-02-28
- Completion
- 2026-02-28
- First posted
- 2025-08-15
- Last updated
- 2026-04-14
Locations
1 site across 1 country: China
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07124039. Inclusion in this directory is not an endorsement.