NCT07124039Completed
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-2.0 China: Finerenone FIRST (Finerenone Research of Early Safety and Effectiveness), Part 2.0 in China
Source: ClinicalTrials.gov · Last updated 14 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 6537 (actual)
- First submitted
- 8 Aug 2025
- Start date
- 16 Jul 2025
- Primary completion date
- 28 Feb 2026
- Lead sponsor
- Bayer
- Diseases
- Chronic kidney disease, Type 2 diabetes
- NCT number
- NCT07124039
What you commit to
- Study type: Observational
- Participants enrolled: 6537
- From 16 Jul 2025 to the primary completion date, 28 Feb 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Lab values
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Inspur Tianjin Regional Electronic Health Records Database Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.