Status:
ACTIVE_NOT_RECRUITING
An Observational Study to Learn More About How Safe Finerenone is and How Well it Works in People With Chronic Kidney Disease and Type 2 Diabetes in Routine Medical Care in the United States
Lead Sponsor:
Bayer
Conditions:
Chronic Kidney Disease
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18+ years
Brief Summary
This is an observational study in which data from people with chronic kidney disease (CKD) and Type 2 diabetes mellitus (T2D) are collected and studied. In observational studies, only observations ar...
Eligibility Criteria
Inclusion
- Inclusion criteria on or before Time 0 (Time 0 = finerenone initiation date) :
- Active registration or continuous enrolment for at least 365 days in the data source before Time 0 (days \[-365, 0\])
- No recorded use of finerenone before Time 0 (days \[-all available, 0\])
- Aged 18 years or older on Time 0
- Diagnosis of T2D at any time on or before Time 0 (days \[-all available, 0\])
- Having a diagnosis code indicating CKD stage 1, 2, 3, 4, or stage unspecified on or before Time 0 (days \[-all available, 0\])
- Exclusion criteria on or before Time 0:
- Finerenone users who are hospitalized or admitted for an emergency department visit on Time 0
- Type 1 diabetes (T1D) at any time on or before Time
- Evidence of end-stage kidney disease (ESKD) at any time on or before Time 0
- A diagnosis of kidney cancer at any time on or before Time 0
- A diagnosis of adrenal insufficiency at any time on or before Time 0
- Evidence of hepatic impairment at any time on or before Time 0
- An eGFR measurement \< 25 mL/min/1.73 m2 on or in the 90 days before Time 0
- Evidence of recent increased serum potassium or hyperkalaemia
- Use of a strong CYP3A4 inhibitor on or in the 183 days before Time 0
- Evidence of pregnancy measured on or in the 40 weeks before Time 0
Exclusion
Key Trial Info
Start Date :
October 9 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
150000 Patients enrolled
Trial Details
Trial ID
NCT06608212
Start Date
October 9 2024
End Date
December 31 2025
Last Update
November 10 2025
Active Locations (1)
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1
Bayer
Whippany, New Jersey, United States, 07981