NCT07524101Recruiting
Moderate-Intensity Statin Plus Ezetimibe in CKD and ASCVD
Utilizing Lipid-lowering Therapy With Moderate-intensity Statin Plus Ezetimibe in Chronic Kidney Disease Patients With Concomitant Atherosclerotic Cardiovascular Disease: ULTRA-CKD Trial
Source: ClinicalTrials.gov · Last updated 16 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 1952 (estimated)
- First submitted
- 3 Apr 2026
- Start date
- 28 May 2026
- Primary completion date
- 22 Jan 2031
- Lead sponsor
- Yonsei University
- NCT number
- NCT07524101
What you commit to
- Study type: Interventional
- Planned participants: 1952
- From 28 May 2026 to the primary completion date, 22 Jan 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Allergy or hypersensitivity to statins.
Lab values
- Baseline LDL cholesterol \<55 mg/dL in the absence of statin therapy.
- Acute liver disease or persistently unexplained serum AST/ALT ≥2 × the upper limit of normal.
Other
- Life expectancy \<1 year.
- Expected inability to complete at least 1 year of follow-up.
- Inability to read or understand the informed consent form.
Who the study is looking for
- Age 19-85 years.
- Chronic kidney disease stage III, IV, or V (CKD-EPI eGFR \<60 / \<30 / \<15 mL/min/1.73 m² or on dialysis).
- Established ASCVD, meeting at least one of the following:
- Prior acute coronary syndrome (myocardial infarction or unstable angina).
- Stable angina confirmed by imaging studies.
- History of coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting).
- Peripheral artery disease.
- Ischemic stroke or transient ischemic attack.
Age in the registry: 19 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Severance hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.