An Observational Study to Learn More About How Safe Finerenone is and How Well it Works in People… (NCT06608212) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
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
United States150,000 participantsStarted 2024-10-09
Plain-language 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 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time to the first occurrence of composite cardiovascular outcome
Timeframe: Retrospective analysis from July 2021 to June 2025