An Observational Study Called FINEROD to Learn More About the Use of the Treatment Finerenone Including How Safe it is and How Well it Works Under Real-world Conditions

Launched by BAYER · Feb 22, 2024

Keywords

ClinConnect Summary

The FINEROD study is looking to learn more about how the treatment finerenone works and how safe it is for people with chronic kidney disease (CKD) and type 2 diabetes (T2D). This study involves participants from Japan and the United States who are already taking finerenone as part of their usual medical care. Researchers want to gather information about these individuals, such as their age, gender, kidney function, and any other medical conditions they may have. By doing this, they can better understand how well finerenone helps patients in real-life situations.

To be eligible for the study, participants must be at least 18 years old, have been receiving continuous medical care for at least a year, and have a diagnosis of T2D along with CKD stages 2 to 4. Participants will not have to visit doctors specifically for this study, as it relies on existing medical records. The study is currently recruiting participants and aims to collect data until March 2024. Since the information is already available, this study will not involve any new tests or treatments, making it a straightforward way to help improve care for patients with CKD and T2D.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• - Kidney failure defined as follows:
• • Two different eGFR test results \< 15 mL/min/1.73 m2 separated by at least 90 days and by not 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; Kidney transplant