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

Study identification

• EU PAS number:
  EUPAS1000000231
• Study ID:
  1000000231
• Official title and acronym:
  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
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  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.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Bayer AG

Networks

HealthVerity® Chronic Kidney Disease Masterset, US RTI-HS, Barcelona, Spain

Study timelines

Date when funding contract was signed

Planned: 31/03/2024

Actual: 14/03/2024

Study start date

Planned: 10/10/2024

Actual: 10/09/2024

Date of final study report

Planned: 31/03/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Bayer AG

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable