FINE-REAL: Non-interventional study to collect real-world data and providing insights into the use of finerenone in routine clinical practice

Study identification

• EU PAS number:
  EUPAS46493
• Study ID:
  50075
• Official title and acronym:
  FINE-REAL: Non-interventional study to collect real-world data and providing insights into the use of finerenone in routine clinical practice
• DARWIN EU® study:
  No
• Study countries:
  Argentina

  Belgium

  Brazil

  Canada

  China

  Denmark

  Germany

  Greece

  Korea, Republic of

  Mexico

  Netherlands

  Portugal

  Saudi Arabia

  Singapore

  Slovenia

  Switzerland

  Taiwan

  Thailand

  United States
• Study description:
  The main purpose of the study is to learn more about treatment patterns in people with CKD and T2D who will start finerenone treatment as decided and prescribed by their doctor as part of their routine medical care. To answer this question, the researchers will collect data on: • Clinical characteristics (e.g., history of CKD and T2D, blood pressure, heart health) of the participants • Reasons for starting finerenone • Reasons for stopping finerenone early • How long participants have been taking finerenone (planned by their doctor compared to actual time it was taken) • Dosing of finerenone • Other medications used while taking finerenone The researchers will also collect data on medical problems (called adverse events) that the participants may have during the study. All adverse events are collected, even if they might not be related to the study treatment. Hyperkalemia, a medical term used to describe a potassium level in the blood that is higher than normal, is of special interest when finerenone is combined with some medications commonly taken to control blood pressure. Researchers want to know how often higher potassium levels occur, and when it leads to: • Stopping finerenone treatment too early • Dialysis (a medical procedure to filter the blood of extra water and waste) • Care in a hospital All data will come from medical records or from interviews study doctors will have with the participants during visits that take place during routine medical care. Participants in the US will be invited to provide voluntary blood and urine samples that could be analyzed later to better understand possible changes in protein or nucleic acid levels over time. Each participant will be in the study for 12 months. This time participating in the study may be shorter if their finerenone treatment is stopped early or the study comes to an end as planned in November 2025.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Bayer AG

Study timelines

Date when funding contract was signed

Planned:09/02/2022

Study start date

Planned:08/06/2022

Actual:13/06/2022

Date of final study report

Planned:30/06/2028

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

Other study registration identification numbers and links

NCT05348733

NCT05348733