The EXCELSIOR-CKD trial is designed to evaluate whether intensive SBP (<120 mmHg) and LDL-C (<70 mg/dL) lowering improves kidney outcomes in advanced CKD; trial results are currently pending.
RCT
Open-label
2 × 2 factorial
Yes
Does intensive blood pressure and lipid control reduce composite kidney outcomes in adults with advanced CKD?
The EXCELSIOR-CKD trial will provide randomized evidence on whether intensive blood pressure and lipid lowering improves kidney outcomes in patients with advanced CKD.
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.
Kim et al. (Tue,) conducted a rct in Advanced chronic kidney disease. Intensive blood pressure and lipid control vs. Standard control (SBP <140 mmHg and LDL-C <100 mg/dL) was evaluated on Time to the first composite kidney outcome (≥40% sustained decline in eGFR, initiation of kidney replacement therapy, sustained eGFR <10 mL/min/1.73 m2, or kidney death). The EXCELSIOR-CKD trial is designed to evaluate whether intensive SBP (<120 mmHg) and LDL-C (<70 mg/dL) lowering improves kidney outcomes in advanced CKD; trial results are currently pending.