Finerenone (Kerendia) use in people with chronic kidney disease and type 2 diabetes in South Korea
FINE-REAL Korea: A Non-interventional Study Providing Insights Into the Use of Finerenone in a Routine Clinical Setting in Korea
This study collects health information to see how finerenone works in adults in South Korea who have chronic kidney disease and type 2 diabetes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bayer Industry-sponsored |
| Locations | 1 site (Multiple Locations) |
| Trial ID | NCT07232537 on ClinicalTrials.gov |
What this trial studies
This observational study will enroll adults in South Korea diagnosed with CKD associated with type 2 diabetes who are prescribed finerenone as part of routine care. Investigators will collect clinical data, laboratory results, and treatment details over time without changing the participant's prescribed care. Finerenone treatment must be started within 8 weeks before or after signing consent, and patients already in other investigational trials are excluded. The aim is to characterize real-world use, safety, and clinical outcomes of finerenone in this population.
Who should consider this trial
Good fit: Adults (≥18 years) in South Korea with chronic kidney disease associated with type 2 diabetes who have been prescribed finerenone within 8 weeks before or after signing consent and are not enrolled in other investigational trials.
Not a fit: People with contraindications to finerenone or those participating in other investigational trials are unlikely to receive benefit from joining this observational study.
Why it matters
Potential benefit: If successful, this could help doctors better understand the real-world safety and kidney and heart benefits of finerenone for people with CKD and type 2 diabetes.
How similar studies have performed: Previous randomized trials (FIDELIO-DKD and FIGARO-DKD) demonstrated clinical benefit of finerenone, but real-world observational data specific to Korea are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult female or male participant - All genders (≥18 years old) * Diagnosis of CKD associated with T2D based on assessment by physician * Treatment according to local marketing authorization, finerenone 20 or 10 mg. Treatment should have been started up to 8 weeks before or after the ICF is signed. * Decision to initiate treatment with finerenone must be made before ICF is signed Exclusion Criteria: * Participation in an investigational trial at any time during the course of this study * Contra-indications according to the local label
Where this trial is running
Multiple Locations
- Many Locations — Multiple Locations, South Korea (Recruiting)
Study contacts
- Study coordinator: Bayer Clinical Trials Contact
- Email: clinical-trials-contact@bayer.com
- Phone: (+)1-888-84 22937
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.