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

Launched by BAYER · Sep 19, 2024

Keywords

ClinConnect Summary

This clinical trial is observing how safe and effective a medication called finerenone is for people with chronic kidney disease (CKD) and type 2 diabetes (T2D) who are receiving routine healthcare in the United States. CKD is a long-term condition where the kidneys gradually lose their ability to function properly, and it often affects individuals with T2D, which is when high blood sugar levels occur. The study aims to collect data on heart-related problems, such as heart attacks and hospitalizations for heart failure, in patients taking finerenone compared to those who are not.

To be eligible for this study, participants must be at least 18 years old, have been diagnosed with T2D, and have a record of CKD. They should not have used finerenone before the study started. Importantly, participants do not need to make extra visits or undergo additional tests; the study uses existing healthcare records to gather information. This means that anyone who qualifies can continue their usual medical care while helping researchers learn more about this medication's impact on heart health.

Gender

ALL

Eligibility criteria

• 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