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.

NCT ID: NCT07124039

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 5000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-07-16
• Study Completion Date: 2026-03-30

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.

Conditions

Chronic Kidney Disease; Type 2 Diabetes Mellitus

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Finerenone users

Patients with chronic kidney disease and type 2 diabetes mellitus from China who initiate finerenone treatment.

Finerenone (Kerendia, BAY948862)

Intervention Type: DRUG

Retrospective cohort analysis using the EHR data from the Tianjin Healthcare and Medical Big Data Platform (China) database.

Interventions

Finerenone (Kerendia, BAY948862)

Retrospective cohort analysis using the EHR data from the Tianjin Healthcare and Medical Big Data Platform (China) database.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Minimum of 12 months continuous enrolment before the index date in the database with medical and pharmacy coverage measured as continuously receiving medical care from health providers contributing to the electronic health record system
• No recorded prescription of finerenone prior to the index date
• Age 18 years or older as of the index date
• Diabetic kidney disease diagnosis by diagnosis texts at any point before (and including) the index date, OR
• T2D diagnosis at any point before (and including) the index date using the same algorithms as in previous studies of the FIRST program, AND

• CKD stages 2-4 related to eligibility will be defined according to the presence of the following criteria at any point before (and including) the index date:
• A diagnosis code/text indicating CKD stage 2, 3, 4, or stage unspecified OR
• Two UACR test results ≥30 mg/g separated by at least 90 days and no more than 548 days.

OR

• Two different eGFR test results ≥15 mL/min/1.73 m2 AND <60 mL/min/1.73 m2 separated by at least 90 days and no more than 548 days.

Exclusion Criteria

• Type 1 diabetes mellitus identified by diagnosis codes/texts in the patient record on or before the index date
• Kidney cancer identified by diagnosis codes/texts on or before the index date
• Kidney failure on or before the index date, defined as:

• Two different eGFR test results <15 mL/min/1.73 m2 separated by at least 90 days and no more than 548 days OR
• Dependence on dialysis (at least 3 sessions over at least 90 days during the baseline period) OR
• A diagnosis code/text indicating kidney failure or CKD stage 5 OR
• A recorded diagnosis indicating kidney transplant

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Inspur Tianjin Regional Electronic Health Records Database

Tianjin, Tianjin Municipality, China

Countries

China

Related Links

https://clinicaltrials.bayer.com/

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Other Identifiers

23030

Identifier Type: -

Identifier Source: org_study_id