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

NCT ID: NCT06301022

Last Updated: 2024-03-08

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-12-15
• Study Completion Date: 2024-12-31

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.

Conditions

Chronic Kidney Diseases

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• CKD without diabetes

Exclusion Criteria

• CKD with diabetes

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Harbin Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

First Aaffiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Site Status: RECRUITING

Countries

China

Facility Contacts

XINGZHI WANG, PHD.,MD

Role: primary

WANG.XINGZHI@HRBMU.EDU.CN

+8613904506176

References

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.

Reference Type: BACKGROUND

PMID: 33198491 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

WXZ-Finerenone

Identifier Type: -

Identifier Source: org_study_id