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Effectiveness and Safety of Finerenone in Chinese CKD Patients Without Diabetes Mellitus

Effectiveness and Safety of Finerenone in Chinese CKD Patients Without Diabetes Mellitus: A Real-world Retrospective Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06301022
Enrollment
90
Registered
2024-03-08
Start date
2022-12-15
Completion date
2024-12-31
Last updated
2024-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Diseases

Keywords

chronic kidney disease, finerenone

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.

Interventions

None listed

Sponsors

First Affiliated Hospital of Harbin Medical University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* CKD without diabetes

Exclusion criteria

* CKD with diabetes

Design outcomes

Primary

MeasureTime frameDescription
24 hours urinary total proteinbefore using finerenone, and after using finerenone assessed on a monthly basis, up to 1 year24 hours urinary total protein
estimate Gromerular filtration ratebefore using finerenone, and after using finerenone assessed on a monthly basis, up to 1 yearChinese estimate Gromerular filtration rate
serum potassiumbefore using finerenone, and after using finerenone assessed on a monthly basis, up to 1 yearserum potassium level

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026