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.

NCT07124039 | Completed FDA Drug

• 1 other identifier: 23030
• Study Type: observational
• Target: 6,537
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• 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

Other Outcomes (4)

• To describe the baseline characteristics, comorbidities, and comedications

  Up to 32 months

• To describe the absolute levels and relative change over time of UACR, eGFR, and serum potassium after initiating finerenone

  Up to 32 months

• To describe the baseline characteristics, comorbidities, comedications, and the absolute levels and relative change over time of UACR, eGFR, and serum potassium after initiating finerenone

  Up to 32 months

Study Arms (1)

Finerenone users

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

Drug: Finerenone (Kerendia, BAY948862)

Interventions

Finerenone (Kerendia, BAY948862) DRUG

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

Finerenone users

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with chronic kidney disease and type 2 diabetes mellitus who initiate finerenone treatment in China

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Inspur Tianjin Regional Electronic Health Records Database

Tianjin, Tianjin Municipality, 301799, China

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Diabetes Mellitus, Type 2

Interventions

finerenone

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2025
• First Posted: August 15, 2025
• Study Start: July 16, 2025
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)