Effectiveness and Safety of Finerenone in Chinese CKD Patients Without Diabetes Mellitus
- Conditions
- Chronic Kidney Diseases
- Registration Number
- NCT06301022
- Lead Sponsor
- First Affiliated Hospital of Harbin Medical University
- Brief Summary
Background： This study aimed to evaluate the effectiveness and safety of Finerenone in patients with chronic kidney disease (CKD) without diabetes mellitus(DM), however, evidence based on both clinical trails and real-world data are limited.
Methods:
Patients with CKD without DM were enrolled in this study from December 2022 to December 2024. In conjunction with the established treatment regimen for chronic kidney disease (CKD), study participants were additionally administered Finerenone. To evaluate the therapeutic impact and safety profile of the intervention, three primary biomarkers were monitored: 24-hour urinary protein (UTP), estimated glomerular filtration rate (eGFR), and serum potassium (sK+). These parameters were closely measured on a monthly basis, starting from the point of enrollment and continuing for a duration of twelve months or possibly longer.
- Detailed Description
Chronic Kidney Disease (CKD) is a significant global health issue that leads to end-stage renal disease (ESRD) and is associated with rising healthcare costs and high mortality rates. Its prevalence is increasing due to aging populations and the growing rates of diabetes and hypertension. CKD causes severe complications and significantly impairs patients' quality of life. There are notable disparities in CKD incidence and treatment among different socioeconomic groups, and many healthcare systems struggle with the challenges of managing and funding the disease.
In terms of treatment, there is a particular bottleneck in addressing CKD among non-diabetic patients. Currently, the focus for non-diabetic CKD patients is on controlling blood pressure and proteinuria. However, new treatments such as finerenone show promise in reducing CKD progression and cardiovascular risks in diabetic patients. Ongoing research aims to explore the effectiveness of these treatments in non-diabetic CKD patients as well. It is important to note that further studies are required to confirm the safety and efficacy of finerenone in these specific populations.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 90
- CKD without diabetes
- CKD with diabetes
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method serum potassium before using finerenone, and after using finerenone assessed on a monthly basis, up to 1 year serum potassium level
estimate Gromerular filtration rate before using finerenone, and after using finerenone assessed on a monthly basis, up to 1 year Chinese estimate Gromerular filtration rate
24 hours urinary total protein before using finerenone, and after using finerenone assessed on a monthly basis, up to 1 year 24 hours urinary total protein
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
First Aaffiliated Hospital of Harbin Medical University
🇨🇳Harbin, Heilongjiang, China