do_not_disturb_altRecruitment Complete
Chronic kidney disease, Type 2 diabetes mellitus
Bayer Identifier:
23030
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
Trial purpose
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.
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.
Key Participants Requirements
Sex
AllAge
18 - N/ATrial summary
Enrollment Goal
5000Trial Dates
July 2025 - March 2026Phase
Phase 4Could I Receive a placebo
NoProducts
Kerendia (Finerenone, BAY94-8862)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Active, not recruiting | Inspur Tianjin Regional Electronic Health Records Database | Tianjin, 301799, China |
Primary Outcome
- Descriptive summary of characteristics of patients who initiate finerenone and have CKD and T2D in China.date_rangeTime Frame:Up to 365 days
- Descriptive summary of comorbidities of patients who initiate finerenone and have CKD and T2D in China.date_rangeTime Frame:Up to 365 days
- Descriptive summary of comedications of patients who initiate finerenone and have CKD and T2D in China.date_rangeTime Frame:Up to 180 days
Secondary Outcome
- To describe the routine monitoring of UACR, eGFR, and serum potassium before and after initiating finerenone in patients with CKD and T2Ddate_rangeTime Frame: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 T2Ddate_rangeTime Frame: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 T2Ddate_rangeTime Frame: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 availabilitydate_rangeTime Frame:Up to 32 months
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A