Study Comparing Biomarker-Guided Treatment Versus Standard Care to Slow Kidney Disease Progression in Adults with Chronic Kidney Disease

What this Trial Is About

Chronic kidney disease CKD affects over 800 million people worldwide and leads to significant health challenges, including multiple secondary diseases, frequent hospital visits, and high costs. Recent advances have identified promising drugs like sodium-glucose co-transporter 2 inhibitors, finerenone, and semaglutide that may slow CKD progression. This study aims to evaluate whether a biomarker-guided treatment approach can better reduce kidney function decline compared to standard care in CKD patients with albuminuria. This prospective, randomized, open-label study plans to enroll 125 participants with CKD and albuminuria who will be randomly assigned to either a biomarker-targeted treatment group or a standard care group. In the treatment group, medications such as dapagliflozin, finerenone, and semaglutide will be added stepwise based on urinary biomarkers UACR and UEGF and individual response. After about four weeks on each drugs maximum tolerated dose, biomarker levels will be reassessed to decide whether to continue, switch, or add treatments. Participants will undergo regular evaluations of kidney function through estimated glomerular filtration rate eGFR and urinary biomarkers throughout the study, which lasts over two years. The main outcome measured is the change in eGFR slope from week 26 to week 104. Additional assessments include changes in eGFR and UACR from baseline to week 104 or 112. Safety and effectiveness of the biomarker-guided approach will be monitored carefully during the trial.

A Biomarker-targeted Clinical Trial to Optimize Treatment for Patients With Chronic Kidney Disease