Moderate-Intensity Statin Plus Ezetimibe in CKD and ASCVD

The ULTRA-CKD trial is a prospective, randomized, open-label, multicenter trial designed to compare the efficacy and safety of moderate-intensity statin plus ezetimibe combination therapy versus high-intensity statin monotherapy in patients with chronic kidney disease (CKD) and concomitant atherosclerotic cardiovascular disease (ASCVD). Patients with CKD are at very high risk for ASCVD. In this population, it is important to establish a lipid-lowering strategy that optimizes cardiovascular outcomes while ensuring long-term safety. While high-intensity statins are generally considered as initial treatment option for secondary prevention, the optimal strategy for CKD patients remains to be clinicaly defined. This study aims to evaluate whether the combination of moderate-intensity statin and ezetimibe is non-inferior to high-intensity statin monotherapy in terms of 3-year composite of major adverse cardiovascular events.

NCT Number	NCT07524101
Lead Sponsor	Yonsei University
Conditions	Renal Insufficiency, Atherosclerosis, Dyslipidemia, Hypercholesterolemia, Cardiovascular Diseases
Enrollment	1,952 participants
Start Date	2026-05-28
Primary Completion	2031-01-22 (estimated)
Study Completion	2031-01-22 (estimated)
Updated on ClinicalTrials.gov	2026-06-16