Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06278207
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-02-09
Brief Title:
An Observational Study Called FINEROD to Learn More About the Use of the Treatment Finerenone Including How Safe it is and How Well it Works Under Real-world Conditions
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
Finerenone Research of Outcomes and Drug Utilization
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FINEROD
Brief Summary:
This is an observational study in which data from people in Japan and in the United States with chronic kidney disease CKD together with type 2 diabetes T2D are studied The participants in this study are already receiving the study treatment finerenone as part of their regular care from their doctors In observational studies only observations are made without specified advice or interventions CKD is a long-term progressive decrease in the kidneys ability to work properly In people with T2D the body does not make enough of a hormone called insulin or does not use insulin well enough The resulting high blood sugar levels can cause damage to the kidneys CKD often occurs together with T2D or as a consequence of T2D Finerenone works by blocking certain proteins called mineralocorticoid receptors By doing this it may reduce damage to kidneys heart and blood vessels Finerenone was recently approved in the US and is now available for doctors to prescribe to people with CKD together with T2D Consequently there is a need to collect more information about how finerenone is used its safety and how well it works under real-world conditions The main purpose of this study is to collect and describe the characteristics of people with CKD and T2D who are receiving initiate finerenone treatment as prescribed by their doctors To do this the researchers will collect general information of the participants such as age or gender and data on kidney function and possible heart problems
The researchers will also collect data on any other disease or medical condition in the participants and on other medications used while taking finerenone
The data will come from a network of commercial electronic health records EHRs and national claims data in the United States and in Japan They cover the period from July 1st 2021 until March 2024 Only already available data is collected and studied There are no required visits or tests in this study
The researchers will also collect data on any other disease or medical condition in the participants and on other medications used while taking finerenone
The data will come from a network of commercial electronic health records EHRs and national claims data in the United States and in Japan They cover the period from July 1st 2021 until March 2024 Only already available data is collected and studied There are no required visits or tests in this study
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None