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

NCT06301022 | Unknown

• 1 other identifier: WXZ-Finerenone
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Diseases

Keywords

chronic kidney disease; finerenone

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• serum potassium

  serum potassium level

  before using finerenone, and after using finerenone assessed on a monthly basis, up to 1 year

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

the medical histories of 43 individuals who received outpatient services at the Department of Nephrology in The First Affiliated Hospital of Harbin Medical University, located in Harbin, China.

You may qualify if:

• CKD without diabetes

You may not qualify if:

• CKD with diabetes

Sponsors & Collaborators

• First Affiliated Hospital of Harbin Medical University: lead

Study Sites (1)

First Aaffiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150001, China

RECRUITING

Related 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.

  PMID: 33198491 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: March 8, 2024
• Study Start: December 15, 2022
• Primary Completion: October 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 8, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 18 months
• Access Criteria: All requests for access to the IPD will be reviewed by the research team to ensure that proposed analyses are scientifically robust, ethical, and capable of contributing meaningful insights to the field.

Locations

CN (1)