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NCT05703880 · ClinicalTrials.gov registry record
An Observational Study Called FIRST-2.0 to Learn More About the Use of the Study Treatment Finerenone Including How Safe it is and How Well it Works Under Real-world Conditions
A clinical trial, sponsored by Bayer.
- Completed
- Registry status
- 15,948
- Enrollment target
NCT05703880: Completed study, sponsored by Bayer.
NCT05703880 is a clinical trial that has completed, run by Bayer. The registered enrollment target is 15,948 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05703880 has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- 15,948 participants
- Enrollment target
Study Summary
This is an observational study, in which data from people in the United States (US) 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 finerenone treatment as prescribed by their doctors. To do this, the researchers will collect data on: * general information of the participants such as age or gender * any other disease or medical condition in the participants * other medications used while taking finerenone. The researchers will also collect data on kidney function and possible heart problems to find out how well finerenone works. Additionally, medical problems possibly related to finerenone treatment will be collected to learn more about how safe finerenone is in real-world use. The data will come from US databases Optum Electronic Health Records (EHR) and OM1 Real-World Data Cloud (RWDC). They will cover the period from July 202
Interventions
- DRUG Finerenone (Kerendia, BAY948862)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15,948 participants |
| Start Date | 2023-06-01 |
| Est. Completion | 2024-10-01 |
What the finished NCT05703880 record still lists
NCT05703880 is an observational study that tracks outcomes without assigning an intervention. Its 15,948 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 1 intervention - of which Finerenone (Kerendia, BAY948862) is the first listed.
NCT05703880 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05703880 about?
NCT05703880 is a clinical study titled "An Observational Study Called FIRST-2.0 to Learn More About the Use of the Study 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 the United States (US) 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....
What is the current status of trial NCT05703880?
This trial is currently completed. The enrollment target is 15,948 participants. The study started on 2023-06-01. Estimated completion is 2024-10-01.
What interventions are being tested in trial NCT05703880?
The interventions under investigation include: Finerenone (Kerendia, BAY948862) (DRUG).
Who is sponsoring clinical trial NCT05703880?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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