NCT05703880Completed
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
Finerenone FIRST (Finerenone Research of Early Safety and Effectiveness), Part 2.0
Source: ClinicalTrials.gov · Last updated 18 Oct 2024
Brief summary (registry, in English)
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 2021 to May 2023. Only already available data is collected and studied. There are no required visits or tests in this study.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 15948 (actual)
- First submitted
- 20 Jan 2023
- Start date
- 1 Jun 2023
- Primary completion date
- 1 Oct 2024
- Lead sponsor
- Bayer
- Diseases
- Chronic kidney disease, Type 2 diabetes
- NCT number
- NCT05703880
What you commit to
- Study type: Observational
- Participants enrolled: 15948
- From 1 Jun 2023 to the primary completion date, 1 Oct 2024
- 2 sites 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.
Other illness
- Type 1 diabetes identified by appropriate algorithms in the data source
- Kidney cancer on or before the index date
Lab values
- Kidney failure defined as:
- Two different eGFR test results \< 15 mL/min/1.73 m\*2 separated by at least 90 days and no more than 540 days
- Dependence on dialysis (at least 3 sessions over at least 90 days during the baseline period)
- A diagnosis code indicating kidney failure or CKD stage 5 (International Classification of Diseases, 10th Revision)
- Kidney transplant
Who the study is looking for
- Minimum of 12 months continuous enrolment in the EHR databases with medical and pharmacy coverage measured as continuously receiving medical care from health providers contributing to the EHR system.
- No recorded prescription of finerenone prior to the index date.
- Age 18 years or older as of the index date.
- T2D diagnosis at any point before (and including) the index date using the same algorithms applicable to the specific data source as in previous studies of the FIRST program.
- CKD stages 2-4 related to eligibility will be defined according to the presence of the following criteria at any point before (and including) the index date:
- A diagnosis code indicating CKD stage 2, 3, 4, or stage unspecified OR
- Two Urinary Albumin-to-Creatinine Ratio (ACR) test results ≥ 30 mg/g separated by at least 90 days and no more than 540 days OR
- Two different eGFR test results ≥ 15 mL/min/1.73 m\*2 AND \< 60 mL/min/1.73 m\*2 separated by at least 90 days and no more than 540 days.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| OM1 Real-World Data Cloud (RWDC) Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Optum electronic health records (EHR) database Coordinator of this site? Confirm its status | Eden Prairie | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.