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NCT06278207 · ClinicalTrials.gov registry record
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
A clinical trial of Type 2 Diabetes Mellitus and Chronic Kidney Disease, sponsored by Bayer.
- Recruiting
- Registry status
- 50,000
- Enrollment target
- 4
- Study locations
NCT06278207 is a study of Type 2 Diabetes Mellitus and Chronic Kidney Disease that is actively recruiting participants, run by Bayer. The registered enrollment target is 50,000 participants, above the 2,339-participant average among 122 other Type 2 Diabetes Mellitus trials with a reported enrollment target (2038% higher). The trial reports 4 study locations across 2 states.
The verdict
NCT06278207, a study of Type 2 Diabetes Mellitus and Chronic Kidney Disease, is actively recruiting participants, sponsored by Bayer.
- RECRUITING
- Registry status
- 50,000 participants
- Enrollment target
- 4
- Study locations
Study Summary
This is an observational study, in which data from people in Asia 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 Asia. They cover the period from July 1st, 2021 until the latest data cut available for each dataset. Only already available data is collected and studied. There are no required visits or tests
Conditions Studied
Interventions
- DRUG Finerenone (BAY 94-8862)
Study Locations (4)
Other
- Bayer - Berlin
- Many Locations - Multiple Locations
- Many Locations - Multiple Locations
New Jersey
- Many Locations - Multiple Locations
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50,000 participants |
| Start Date | 2024-05-15 |
| Est. Completion | 2026-03-31 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06278207
The ClinicalTrials.gov registry entry for NCT06278207 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 50,000 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 2,339-participant average among 122 other Type 2 Diabetes Mellitus trials with a reported enrollment target (2038% higher). The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Type 2 Diabetes Mellitus appearing as the primary indexed condition, and to 1 intervention - of which Finerenone (BAY 94-8862) is the first listed.
NCT06278207 reports 4 study locations spanning 2 distinct geographic areas - top geographies include Other, New Jersey.
Frequently Asked Questions
What is clinical trial NCT06278207 about?
NCT06278207 is a clinical study titled "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". This is an observational study, in which data from people in Asia 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 d...
What is the current status of trial NCT06278207?
This trial is currently recruiting. The enrollment target is 50,000 participants. The study started on 2024-05-15. Estimated completion is 2026-03-31.
What conditions does trial NCT06278207 study?
This clinical trial studies the following conditions: Type 2 Diabetes Mellitus, Chronic Kidney Disease.
What interventions are being tested in trial NCT06278207?
The interventions under investigation include: Finerenone (BAY 94-8862) (DRUG).
Who is sponsoring clinical trial NCT06278207?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06278207 being conducted?
This trial has 4 study locations across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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