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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Aaffiliated Hospital of Harbin Medical University | Recruiting | Harbin | Heilongjiang | 150001 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33198491 | Background | 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. |
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Types of Data to be Shared:
Data Access Format and Procedures:
Data will be made available through a secure access system to bonafide researchers upon completion of a formal application process, which includes a review of the proposed research and a signed data access agreement that outlines the terms and conditions of data use.
Data Availability Time Frame:
Anonymized IPD will be made available for sharing 18 months after the primary study results have been published to allow sufficient time for the research team to conduct primary analyses.
18 months
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.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 15, 2023 | Feb 26, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |