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Clinical Trial Details

Trial ID: L1239
Source ID: NCT06838416
Associated Drug: Finerenone
Title: Evaluation of the Effect of Finerenone on Renal Function in Patients With Type 2 Diabetes and Chronic Kidney Disease
Acronym: KSD-01
Status: RECRUITING
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus|Chronic Kidney Disease|Renal Function
Interventions: DRUG: Finerenone
Outcome Measures: Primary: Change in Urine Albumin-to-Creatinine Ratio (UACR), The primary outcome measure is the change in Urine Albumin-to-Creatinine Ratio (UACR) from baseline to the end of the 48-week treatment period. UACR is a key indicator of renal function and will be assessed to evaluate the efficacy of finerenone in reducing proteinuria in patients with Type 2 diabetes and chronic kidney disease., Baseline to Week 48 | Secondary: Change in eGFR, The change in estimated Glomerular Filtration Rate (eGFR) from baseline to the end of the 48-week treatment period. eGFR is a key marker of renal function and will be used to assess the impact of finerenone on kidney function in patients with Type 2 diabetes and chronic kidney disease., Baseline to Week 48|Change in 24-Hour Urine Protein Quantification, The change in 24-hour urine protein quantification from baseline to the end of the 48-week treatment period. This measure will provide additional insight into the effect of finerenone on proteinuria in patients with chronic kidney disease., Baseline to Week 48|Change in Blood Uric Acid Levels, The change in serum uric acid levels from baseline to the end of the 48-week treatment period. Elevated uric acid levels are associated with renal dysfunction, and this measure will help assess the broader metabolic effects of finerenone., Baseline to Week 48|Change in Pulse Wave Velocity (PWV), The change in pulse wave velocity (PWV) from baseline to the end of the 48-week treatment period. PWV is a measure of arterial stiffness and will be used to assess the impact of finerenone on cardiovascular health., Baseline to Week 48|Change in Ankle-Brachial Index (ABI), The change in Ankle-Brachial Index (ABI) from baseline to the end of the 48-week treatment period. ABI is a measure of peripheral arterial disease and will be used to assess the impact of finerenone on peripheral vascular health., Baseline to Week 48|Changes in Echocardiographic Measurements Title: Changes in Echocardiographic Measurements, Changes in echocardiographic parameters (e.g., left ventricular mass index, ejection fraction) from baseline to the end of the 48-week treatment period. These measures will provide insights into the cardiovascular effects of finerenone in patients with Type 2 diabetes and chronic kidney disease., Baseline to Week 48
Sponsor/Collaborators: Sponsor: Second Affiliated Hospital of Soochow University
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 300
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2023-11-17
Completion Date: 2026-12-31
Results First Posted:
Last Update Posted: 2025-04-04
Locations: The Second Affiliated Hospital of Suzhou University, Suzhou, Jiangsu, China
URL: https://clinicaltrials.gov/show/NCT06838416