Rationale and design of the EXCELSIOR-CKD trial: intensive blood pressure and lipid control in advanced chronic kidney disease.

Abstract

Background Although blood pressure and lipid control are key in advanced chronic kidney disease (CKD), the optimal targets for systolic blood pressure (SBP) and low-density lipoprotein cholesterol (LDL-C) remain unclear because patients with estimated glomerular filtration rate (eGFR) <45 mL/min/1.73 m2 were often excluded or underrepresented in prior trials. This study aims to compare the clinical outcomes of intensive versus standard control strategies for SBP and LDL-C in patients with advanced CKD. Methods This multicenter, open-label, randomized controlled trial with a 2 × 2 factorial design is being conducted across 13 centers in Korea. Adults aged ≥19 years with eGFR ≥15 and <45 mL/min/1.73 m2 , SBP ≥130 mmHg, and LDL-C ≥100 mg/dL are eligible. Participants will be randomized according to intensive or standard targets for SBP (<120 mmHg vs. <140 mmHg) and LDL-C (<70 mg/dL vs. <100 mg/dL). The effects of blood pressure and lipid interventions will be evaluated independently, sharing the same primary endpoint: time to the first composite kidney outcome, including ≥40% sustained decline in eGFR, initiation of kidney replacement therapy, sustained eGFR <10 mL/min/1.73 m2 , or kidney death. Secondary endpoints will include eGFR slope and major adverse cardiovascular events. Participants will be followed up for 3 years, with an additional 3 years for the observational phase. Results This report describes the rationale and design; trial results are pending. Conclusion As the first randomized trial to determine whether intensive SBP and LDL-C lowering improve kidney outcomes in advanced CKD, this study could help define optimal targets and inform future guideline recommendations.