An Observational Study Called FIRST-2.0 China to Learn More About the Use of the Study Treatment … (NCT07124039) | Clinical Trial Compass
CompletedNot Applicable
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.
China6,537 participantsStarted 2025-07-16
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 d…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Descriptive summary of characteristics of patients who initiate finerenone and have CKD and T2D in China.
Timeframe: Up to 365 days
2
Descriptive summary of comorbidities of patients who initiate finerenone and have CKD and T2D in China.
Timeframe: Up to 365 days
3
Descriptive summary of comedications of patients who initiate finerenone and have CKD and T2D in China.