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_CN)

Bayer

Status: Active, not recruiting

Conditions: Chronic Kidney Disease; Type 2 Diabetes Mellitus

Treatments: Drug: Finerenone (Kerendia, BAY948862)

Study type: Observational

Funder types: Industry

Identifiers

NCT07124039

23030

Details and patient eligibility

About

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.

Enrollment: 5,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

5,000 participants in 1 patient group

Finerenone users

Description:

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

Treatment:

Drug: Finerenone (Kerendia, BAY948862)