do_not_disturb_altRecruitment Complete
Chronic kidney disease, Type 2 diabetes mellitus
Bayer Identifier:
22663
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Trial purpose
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 participant’s data is no longer available, there is a change in the participant’s 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 participant’s data is no longer available, there is a change in the participant’s 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.
Key Participants Requirements
Sex
AllAge
18 - N/ATrial summary
Enrollment Goal
150000Trial Dates
October 2024 - June 2025Phase
Phase 4Could I Receive a placebo
NoProducts
Kerendia (Finerenone, BAY94-8862)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Not yet recruiting | Bayer | Whippany, 07981, US |
Primary Outcome
- Time to the first occurrence of composite cardiovascular outcomeThe composite cardiovascular outcome includes an inpatient hospital diagnosis of fatal or nonfatal acute myocardial infarction or an inpatient hospitalisation with a primary diagnosis of heart failure.date_rangeTime Frame:Retrospective analysis from July 2021 to June 2025
Secondary Outcome
- Time to the first occurrence of an inpatient hospital diagnosis of fatal or nonfatal acute myocardial infarctiondate_rangeTime Frame:Retrospective analysis from July 2021 to June 2025
- Time to the first occurrence of an inpatient hospitalisation with a primary diagnosis of heart failuredate_rangeTime Frame:Retrospective analysis from July 2021 to June 2025
- Time to the first occurrence of an inpatient hospital or emergency department diagnosis of heart failure for participants without a history of heart failuredate_rangeTime Frame:Retrospective analysis from July 2021 to June 2025
- Time to occurrence of specific Urine Albumin-Creatine Ratio (UACR) decline thresholdsdate_rangeTime Frame:Retrospective analysis from July 2021 to June 2025
- Time to the first occurrence of a hospitalisation or emergency department visit with a diagnosis code for hyperkalaemiadate_rangeTime Frame:Retrospective analysis from July 2021 to June 2025
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
TreatmentAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A