Skip to main content
OpenTrials
Completed

NCT Number: NCT07124039

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.

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.

Completed

Looking for future studies?

Notify Me

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Finerenone (Kerendia, BAY948862)

Drug

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

Primary outcomes

  1. Descriptive summary of characteristics of patients who initiate finerenone and have CKD and T2D in China.

    Time frame: Up to 365 days

  2. Descriptive summary of comorbidities of patients who initiate finerenone and have CKD and T2D in China.

    Time frame: Up to 365 days

  3. Descriptive summary of comedications of patients who initiate finerenone and have CKD and T2D in China.

    Time frame: Up to 180 days

Secondary outcomes

  1. To describe the routine monitoring of UACR, eGFR, and serum potassium before and after initiating finerenone in patients with CKD and T2D

    Time frame: Up to 32 months

  2. 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

    Time frame: Up to 32 months

  3. 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

    Time frame: Up to 32 months

  4. 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

    Time frame: Up to 32 months

Other outcomes

  1. To describe the baseline characteristics, comorbidities, and comedications

    Time frame: Up to 32 months

    In patients with CKD and T2D in sub-cohorts of patients stratified by baseline UACR level (<30 mg/g, 30-300 mg/g, >300 mg/g), depending on data availability

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

    Time frame: Up to 32 months

    In patients with CKD and T2D in sub-cohorts of patients stratified by baseline UACR level (<30 mg/g, 30-300 mg/g, >300 mg/g), depending on data availability

  3. 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

    Time frame: Up to 32 months

    In patients with CKD and T2D in sub-cohorts of patients stratified by baseline UACR and eGFR level (e.g., UACR ≥30 mg/g with eGFR <60 mL/min/1.73m2, UACR ≥30 mg/g with eGFR ≥60 mL/min/1.73m2, UACR <30 mg/g with eGFR <60 mL/min/1.73m2), depending on data availability

  4. To describe the finerenone utilization patterns

    Time frame: Up to 32 months

    In patients with CKD and T2D who initiate finerenone, depending on data availability. Frequency of finerenone use during follow-up, dosing regimen, treatment discontinuation, treatment duration, and treatment persistence will be assessed based on data availability

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

FIRST-2.0 China: Finerenone FIRST (Finerenone Research of Early Safety and Effectiveness), Part 2.0 in China

Acronym: FIRST-2_CN

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 15, 2025
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.