NCT06608212Completed
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
FIRST-2.5: Finerenone Research of Early Safety and Effectiveness, Part 2.5
Source: ClinicalTrials.gov · Last updated 16 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 238038 (actual)
- First submitted
- 19 Sept 2024
- Start date
- 9 Oct 2024
- Primary completion date
- 31 Mar 2025
- Lead sponsor
- Bayer
- Diseases
- Chronic kidney disease, Type 2 diabetes
- NCT number
- NCT06608212
What you commit to
- Study type: Observational
- Participants enrolled: 238038
- From 9 Oct 2024 to the primary completion date, 31 Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Lab values
- An eGFR measurement \< 25 mL/min/1.73 m\^2 on or in the 90 days before Time 0
- Evidence of recent increased serum potassium or hyperkalaemia
Other
- Finerenone users who are hospitalized or admitted for an emergency department visit on Time 0
Who the study is looking for
- 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 \[-all available, 0\])
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Bayer Coordinator of this site? Confirm its status | Whippany | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.