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.

Active, not recruiting

• Conditions: Chronic Kidney Disease; Type 2 Diabetes Mellitus
• Interventions: Drug: Finerenone (Kerendia, BAY948862)

• Registration Number: NCT07124039
• Lead Sponsor: Bayer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-07-16
• Status Verified: 2025-08
• Study First Submitted: 2025-08-08
• Study First Submitted QC: 2025-08-08
• Last Update Submitted: 2025-08-08
• Study First Posted: 2025-08-15
• Last Update Posted: 2025-08-15
• Primary Completion: 2026-03-30
• Study Completion: 2026-03-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Finerenone users	Finerenone (Kerendia, BAY948862)	Patients with chronic kidney disease and type 2 diabetes mellitus from China who initiate finerenone treatment.

Primary Outcome Measures

Name	Time	Method
Descriptive summary of characteristics of patients who initiate finerenone and have CKD and T2D in China.	Up to 365 days
Descriptive summary of comorbidities of patients who initiate finerenone and have CKD and T2D in China.	Up to 365 days
Descriptive summary of comedications of patients who initiate finerenone and have CKD and T2D in China.	Up to 180 days

Secondary Outcome Measures

Name	Time	Method
To describe the routine monitoring of UACR, eGFR, and serum potassium before and after initiating finerenone in patients with CKD and T2D	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	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	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	Up to 32 months

Trial Locations

Locations (1)

Inspur Tianjin Regional Electronic Health Records Database; 🇨🇳 Tianjin, Tianjin, China