An Observational Study Called FINE-REAL Korea to Learn More About the Use of the Drug Finerenone in People With Chronic Kidney Disease and Type 2 Diabetes in a Routine Medical Care Setting in South Korea
- Conditions
- Chronic Kidney DiseaseType 2 Diabetes Mellitus
- Interventions
- Registration Number
- NCT07232537
- Lead Sponsor
- Bayer
- Brief Summary
This is an observational study in which data from people with chronic kidney disease (CKD) and type 2 diabetes (T2D) who will be receiving finerenone are collected and studied.
Chronic kidney disease is a long-term condition where the kidneys gradually lose their ability to filter waste and extra water from the blood. Type 2 diabetes occurs when the body does not produce enough insulin or does not use it effectively, leading to high blood sugar levels that can harm the kidneys. As a result, CKD can develop as a complication of T2D.
The study drug, finerenone, is already approved for doctors to prescribe to patients with CKD and T2D.
Finerenone is a medication that works by blocking certain proteins known as mineralocorticoid receptors. An increased stimulation of these proteins is thought to damage the kidneys and the heart. By lowering their stimulation, finerenone reduces the risk of kidney disease progressively getting worse.
The main purpose of this study is to learn more about characteristics and treatment patterns of people with CKD and T2D who have recently started or will start finerenone treatment as prescribed by their doctor as part of their routine medical care in South Korea.
The FINE-REAL Korea study is designed to collect additional data on people with CKD and T2D who are treated with finerenone according to the approved product information, and it will work alongside the original FINE-REAL study (NCT05348733) to gather enough information for safety assessments in Korean population.
To achieve this, researchers will collect data on:
* Clinical characteristics of participants, including their medical history related to CKD and T2D, blood pressure, and heart health.
* Reasons for starting finerenone.
* Reasons for stopping finerenone early.
* The planned and actual duration of finerenone treatment.
* The dosing of finerenone.
* Other medications taken alongside finerenone.
The study will also monitor any medical problems (known as adverse events) that participants may experience during the study. All adverse events will be recorded, regardless of whether they are related to the treatment.
One specific concern is hyperkalemia, which refers to high potassium levels in the blood. This condition can occur when finerenone is used with certain blood pressure medications. Researchers want to understand how often hyperkalemia happens and whether it leads to:
* Early discontinuation of finerenone treatment.
* The need for dialysis, a procedure that filters waste from the blood.
* Hospitalization for care.
Data for this study will be collected from medical records and through interviews conducted by study doctors during routine medical visits.
Participants will be involved in the study for up to 12 months, although this duration may be shorter if their finerenone treatment is stopped early.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 500
- 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
- Participation in an investigational trial at any time during the course of this study
- Contra-indications according to the local label
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Participants diagnosed with CKD and T2D Kerendia (Finerenone, BAY94-8862) Participants who are newly prescribed finerenone under routine treatment conditions.
- Primary Outcome Measures
Name Time Method Descriptive analysis of clinical characteristics of participants with chronic kidney disease (CKD) and with type 2 diabetes (T2D) Up to 12 months after start of finerenone Descriptive summary of reasons for introducing finerenone Up to 12 months after start of finerenone Planned and actual duration of treatment with finerenone Up to 12 months after start of finerenone Descriptive summary of secondary therapies used in participants with CKD and T2D Up to 12 months after start of finerenone Descriptive summary of reasons for discontinuation of finerenone Up to 12 months after start of finerenone Planned and actual dosing of finerenone Up to 12 months after start of finerenone
- Secondary Outcome Measures
Name Time Method Occurrence of adverse events (AEs) Up to 30 days after the final treatment with finerenone Including treatment emergent adverse events (TEAEs), adverse drug reactions (ADRs), unexpected AEs, unexpected ADRs, serious adverse events (SAEs), and serious adverse drug reactions (SADRs)
Occurrence of hyperkalemia Up to 30 days after the final treatment with finerenone Reported hyperkalemia leading to permanent study drug discontinuation, dialysis or hospitalization
Trial Locations
- Locations (1)
Many Locations
🇰🇷Many Locations, South Korea
Many Locations🇰🇷Many Locations, South Korea