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

Chronic Kidney Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06301022
• Other study ID #: WXZ-Finerenone
• Status: Recruiting
• Start date: December 15, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: First Affiliated Hospital of Harbin Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

• CKD without diabetes

Exclusion Criteria:

• CKD with diabetes

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Diabetes Mellitus
• Kidney Diseases
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
China	First Aaffiliated Hospital of Harbin Medical University	Harbin	Heilongjiang

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Harbin Medical University

Country where clinical trial is conducted

China, 

References & Publications (1)

Filippatos G, Anker SD, Agarwal R, Pitt B, Ruilope LM, Rossing P, Kolkhof P, Schloemer P, Tornus I, Joseph A, Bakris GL; FIDELIO-DKD Investigators. Finerenone and Cardiovascular Outcomes in Patients With Chronic Kidney Disease and Type 2 Diabetes. Circulation. 2021 Feb 9;143(6):540-552. doi: 10.1161/CIRCULATIONAHA.120.051898. Epub 2020 Nov 16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24 hours urinary total protein	24 hours urinary total protein	before using finerenone, and after using finerenone assessed on a monthly basis, up to 1 year
Primary	estimate Gromerular filtration rate	Chinese estimate Gromerular filtration rate	before using finerenone, and after using finerenone assessed on a monthly basis, up to 1 year
Primary	serum potassium	serum potassium level	before using finerenone, and after using finerenone assessed on a monthly basis, up to 1 year