Clinical trial NCT06301022: Effectiveness and Safety of Finerenone in Chinese CKD Patients Without Diabetes Mellitus
Official title: Effectiveness and Safety of Finerenone in Chinese CKD Patients Without Diabetes Mellitus: A Real-world Retrospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Kidney Diseases
Keywords: chronic kidney disease
finerenone
Lead sponsor: First Affiliated Hospital of Harbin Medical University
Sponsor class: OTHER
First posted: 2024-03-08
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: Inclusion Criteria:

* CKD without diabetes

Exclusion Criteria:

* CKD with diabetes

Primary outcomes:
measure: 24 hours urinary total protein
timeFrame: before using finerenone, and after using finerenone assessed on a monthly basis, up to 1 year
measure: estimate Gromerular filtration rate
timeFrame: before using finerenone, and after using finerenone assessed on a monthly basis, up to 1 year
measure: serum potassium
timeFrame: before using finerenone, and after using finerenone assessed on a monthly basis, up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Harbin
country: China
facility: First Aaffiliated Hospital of Harbin Medical University
state: Heilongjiang
Study officials:
References:
citation: 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.