Utilizing lipid-lowering therapy with moderate-intensity statin plus ezetimibe in chronic kidney disease patients with concomitant atherosclerotic cardiovascular disease: ULTRA-CKD trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0011864

Enrollment

1952

Registered

2026-04-16

Start date

2026-06-01

Completion date

Unknown

Last updated

2026-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Two lipid-lowering strategies will be compared. (1) The high-intensity statin monotherapy group will receive atorvastatin 40 mg once daily as the default regimen. (2) The moderate-intensity sta

within the combination therapy arm, participants will also be assigned 1:1 to a pitavastatin-based or atorvastatin-based regimen. The LDL-C target is <70 mg/dL. Dose adjustment, crossover to the non-a

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age 19–85 years 2. Chronic kidney disease stage III, IV, or V (CKD-EPI eGFR <60 / <30 / <15 mL/min/1.73 m² or on dialysis) 3. Established atherosclerotic cardiovascular disease (ASCVD), defined as meeting at least one of the following: 1) Prior acute coronary syndrome (myocardial infarction or unstable angina) 2) Stable angina confirmed by imaging studies 3) History of coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) 4) Peripheral artery disease 5) Ischemic stroke or transient ischemic attack

Exclusion criteria

Exclusion criteria: 1. Baseline LDL cholesterol <55 mg/dL in the absence of statin therapy 2. Acute liver disease or persistently unexplained serum AST/ALT levels =2 × the upper limit of normal 3. Allergy or hypersensitivity to statins 4. Life expectancy <1 year 5. Expected inability to complete at least 1 year of follow-up 6. Inability to read or understand the informed consent form

Design outcomes

Primary

Measure	Time frame
Composite of cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization over 3 years	—

Secondary

Measure	Time frame
CKD progression: =40% decline in eGFR from baseline, confirmed on at least two consecutive measurements during follow-up.	—

Countries

Korea, Republic of

Contacts

Public ContactJung-Sun Kim

Yonsei University Health System, Severance Hospital

kjs1218@yuhs.ac+82-2-2228-8457

Outcome results