Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06608212
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-19
Brief Title:
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
Sponsor:
None
Organization:
None
Study Overview
Official Title:
FIRST-25 Finerenone Research of Early Safety and Effectiveness Part 25
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 are made without participants receiving any advice or any changes to healthcare
CKD is a long-term condition in which the kidneys ability to work properly gradually decreases over time It is common in people with Type 2 diabetes mellitus T2D a condition in which glucose levels rise in the blood People who have T2D and CKD may also develop heart disease over time
The study drug finerenone is already approved for doctors to prescribe to people with CKD and T2D in the US It blocks the activity of a protein involved in worsening kidney function
The participants in this study are allowed to take finerenone as part of their regular care from their doctors
The main purpose of the study is to learn about how safe finerenone is and how well it works in people with CKD and T2D in routine medical care To do this researchers will collect information about the time to first occurrence of any of the following heart-related problems for participants in the US who are taking finerenone and those who are not taking it
Heart attacks
Hospitalization due to heart failure The data will come from the electronic healthcare records of people with CKD and T2D in the US who are allowed to take finerenone after July 2021
Researchers will track participants data and will follow them until the occurrence of heart-related problems the participants data is no longer available there is a change in the participants treatment strategy or the end of the study
In this study only available data from routine care are collected No visits or tests are required as part of this study
In observational studies only observations are made without participants receiving any advice or any changes to healthcare
CKD is a long-term condition in which the kidneys ability to work properly gradually decreases over time It is common in people with Type 2 diabetes mellitus T2D a condition in which glucose levels rise in the blood People who have T2D and CKD may also develop heart disease over time
The study drug finerenone is already approved for doctors to prescribe to people with CKD and T2D in the US It blocks the activity of a protein involved in worsening kidney function
The participants in this study are allowed to take finerenone as part of their regular care from their doctors
The main purpose of the study is to learn about how safe finerenone is and how well it works in people with CKD and T2D in routine medical care To do this researchers will collect information about the time to first occurrence of any of the following heart-related problems for participants in the US who are taking finerenone and those who are not taking it
Heart attacks
Hospitalization due to heart failure The data will come from the electronic healthcare records of people with CKD and T2D in the US who are allowed to take finerenone after July 2021
Researchers will track participants data and will follow them until the occurrence of heart-related problems the participants data is no longer available there is a change in the participants treatment strategy or the end of the study
In this study only available data from routine care are collected No visits or tests are required as part of this study
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None