Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06301022
Status:
RECRUITING
Last Update Posted:
2024-03-08
First Post:
2024-01-04
Brief Title:
Effectiveness and Safety of Finerenone in Chinese CKD Patients Without Diabetes Mellitus
Sponsor:
First Affiliated Hospital of Harbin Medical University
Organization:
First Affiliated Hospital of Harbin Medical University
Study Overview
Official Title:
Effectiveness and Safety of Finerenone in Chinese CKD Patients Without Diabetes Mellitus A Real-world Retrospective Study
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background This study aimed to evaluate the effectiveness and safety of Finerenone in patients with chronic kidney disease CKD without diabetes mellitusDM 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None