Finerenone Research of Outcomes and Drug Utilization

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Observational
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 in this study.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• A minimum of 12 months of continuous enrolment in the databases with medical and pharmacy coverage measured as continuously receiving medical care from health providers contributing to the EHR or claims system, depending on the database used

• No recorded prescription for finerenone in the 12 months prior to the index date

• Age of 18 years or older as of the index date

• Evidence of T2D at any point before (and including) the index date.

• 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

⁃ two UACR tests results ≥ 30 mg/g separated by at least 90 days and by not more than 540 days

⁃ two different eGFR test results ≥ 15 mL/min/1.73 m2 AND \< 60 mL/min/1.73 m2 separated by at least 90 days and by not more than 540 days

Locations
United States
New Jersey
Many Locations
COMPLETED
Multiple Locations
Other Locations
Germany
Bayer
RECRUITING
Berlin
Japan
Many Locations
COMPLETED
Multiple Locations
Taiwan
Many Locations
NOT_YET_RECRUITING
Multiple Locations
Contact Information
Primary
Bayer Clinical Trials Contact
clinical-trials-contact@bayer.com
(+)1-888-84 22937
Time Frame
Start Date: 2024-05-15
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 50000
Treatments
Adult patients with CKD and T2D who initiate finerenone
The data sources used include a network of commercial electronic health records (EHRs) and national claims data in Asia and in the United States.
Related Therapeutic Areas
Sponsors
Leads: Bayer

This content was sourced from clinicaltrials.gov