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

The study is a prospective, randomized, open-label, parallel-group, multicenter study. CKD-bioMatch will enroll 125 individuals with CKD (eGFR ≥ 25 mL/min/1.73m² and UACR 100-5000 mg/g). Participants will be randomized 1:1 to a biomarker-targeted treatment approach versus standard of care. In the treatment arm, a sequence of pharmacological treatments will be added (dapagliflozin, finerenone, and/or semaglutide), guided by the participant's characteristics and the urinary biomarkers urinary albumin-to-creatinine ratio (UACR) and urinary epidermal growth factor (UEGF). Participants will start treatment with one of the three study medications. After approximately four weeks on the maximum tolerated dose of the allocated medication, UACR and UEGF will be measured, and based on the biomarker response, a decision will be made to continue, switch, or add a new treatment. If a second drug is initiated, the treatment effect of that second drug will be evaluated on UACR and UEGF after four weeks on the maximum tolerated dose, and if the UACR response is insufficient, a third drug can be added, or the third drug can replace the second drug. The biomarker response of the third drug will be evaluated in the same manner as that of the first two drugs.