Many Locations
Multiple Locations, South Korea
Location status: Recruiting
NCT Number: NCT07232537
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Multiple Locations, South Korea
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Decision will be taken by the treating physician to initiate treatment with finerenone.
Time frame: Up to 12 months after start of finerenone
Time frame: Up to 12 months after start of finerenone
Time frame: Up to 12 months after start of finerenone
Time frame: Up to 12 months after start of finerenone
Time frame: Up to 12 months after start of finerenone
Time frame: Up to 12 months after start of finerenone
Time frame: 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)
Time frame: Up to 30 days after the final treatment with finerenone
Reported hyperkalemia leading to permanent study drug discontinuation, dialysis or hospitalization
Contact information is provided by the study sponsor or research team.
Bayer
Industry
FINE-REAL Korea: A Non-interventional Study Providing Insights Into the Use of Finerenone in a Routine Clinical Setting in Korea
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07554469
Chronic Disease, Chronic Kidney Disease
Multiple Locations, Spain
View Trial DetailsNCT06278207
Chronic Disease, Chronic Kidney Disease
Multiple Locations, New Jersey, United States
View Trial DetailsNCT06838416
Chronic Disease, Chronic Kidney Disease
Suzhou, Jiangsu, China
View Trial DetailsNCT03569735
Atrophy, Body Weight
Shenzhen, Guangdong, China
View Trial Details