Renal InsufficiencyNCT07524101
Moderate-Intensity Statin Plus Ezetimibe in CKD and ASCVD
A study testing Moderate-intensity statin and ezetimibe combination therapy and High-intensity statin monotherapy in people with Renal Insufficiency and Atherosclerosis, run by Yonsei University at 1 site in South Korea.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Renal Insufficiency, Atherosclerosis, Dyslipidemia
- What is being tested?
- Moderate-intensity statin and ezetimibe combination therapy and High-intensity statin monotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,952 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 May 2026to 22 Jan 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- Allergy or hypersensitivity to statins.
- Life expectancy <1 year.
- Expected inability to complete at least 1 year of follow-up.
- Inability to read or understand the informed consent form.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Severance Hospital
Seoul, 03722
Jung-Sun Kim, Professor, +82-2-2228-8460, kjs1218@yuhs.ac
About this study
Official title: Utilizing Lipid-lowering Therapy With Moderate-intensity Statin Plus Ezetimibe in Chronic Kidney Disease Patients With Concomitant Atherosclerotic Cardiovascular Disease: ULTRA-CKD Trial
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.
Read the detailed description
All eligible patients with chronic kidney disease (CKD) and concomitant atherosclerotic cardiovascular disease (ASCVD) will be enrolled according to inclusion/exclusion criteria after voluntary agreement with informed consent.
At the time of enrollment, we will stratify the patients according to diabetes mellitus and dialysis status, and randomly assign them in two groups according to lipid-lowering regimen with a 1:1 ratio: "Moderate-intensity statin plus ezetimibe group" vs. "High-intensity statin monotherapy group".
In this study, the combination therapy strategy will utilize Pitavastatin 1-4 mg plus Ezetimibe 10 mg once daily or Atorvastatin 10-20 mg plus Ezetimibe 10 mg once daily. The monotherapy strategy will utilize Atorvastatin 40 mg once daily.
Study visits are scheduled at 4 weeks and at 6, 12, 18, 24, 30, and 36 months. The primary outcome is the composite of cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization. The key secondary outcome is CKD progression defined as a ≥40% decline in eGFR confirmed on at least two consecutive measurements
- Conditions
- Renal Insufficiency, Atherosclerosis, Dyslipidemia, Hypercholesterolemia, Cardiovascular Diseases
- Being tested
- Moderate-intensity statin and ezetimibe combination therapy, High-intensity statin monotherapy
- Medical subject headings
- Renal Insufficiency, Atherosclerosis, Dyslipidemias, Hypercholesterolemia, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate-intensity statin and ezetimibe combination therapyDrug
Participants will receive moderate-intensity statin plus ezetimibe (pitavastatin 1-4 mg + ezetimibe 10 mg once daily or atorvastatin 10-20 mg + ezetimibe 10 mg once daily), with 36-month follow-up.
High-intensity statin monotherapyDrug
Participants will receive high-intensity statin monotherapy (atorvastatin 40 mg once daily), with 36-month follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Moderate-intensity statin and ezetimibe combination therapy | Experimental | Participants will receive moderate-intensity statin plus ezetimibe (pitavastatin 1-4 mg + ezetimibe 10 mg once daily or atorvastatin 10-20 mg + ezetimibe 10 mg once daily), with 36-month follow-up. Receives: Drug: Moderate-intensity statin and ezetimibe combination therapy |
| High-intensity statin monotherapy | Active comparator | Participants will receive high-intensity statin monotherapy (atorvastatin 40 mg once daily), with 36-month follow-up. Receives: Drug: High-intensity statin monotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiovascular events
Composite of cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization.
Measured: 3 years
Secondary outcomes (26)
CKD progression
CKD progression: ≥40% decline in eGFR from baseline, confirmed on at least two consecutive measurements during follow-up.
Measured: 3 years
Cardiovascular death.
Death due to cardiovascular causes during follow-up.
Measured: 3 years
Myocardial infarction.
Occurrence of myocardial infarction during follow-up.
Measured: 3 years
Stroke.
Occurrence of stroke during follow-up
Measured: 3 years
Hospitalization for unstable angina.
Hospitalization due to unstable angina during follow-up.
Measured: 3 years
Coronary revascularization.
Any coronary revascularization procedure, including percutaneous coronary intervention or coronary artery bypass graft surgery, during follow-up.
Measured: 3 years
Composite of cardiovascular death, myocardial infarction, and stroke.
First occurrence of cardiovascular death, myocardial infarction, or stroke during follow-up.
Measured: 3 years
Composite of cardiovascular death, myocardial infarction, stroke, and hospitalization for unstable angina
First occurrence of cardiovascular death, myocardial infarction, stroke, or hospitalization for unstable angina during follow-up
Measured: 3 years
Composite of cardiovascular death, myocardial infarction, stroke, and coronary revascularization.
First occurrence of cardiovascular death, myocardial infarction, stroke, or coronary revascularization during follow-up.
Measured: 3 years
Composite of all-cause death, myocardial infarction, stroke, hospitalization for unstable angina, and coronary revascularization.
First occurrence of all-cause death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization during follow-up.
Measured: 3 years
Proportion of participants achieving the LDL-C <70 mg/dL in each group.
Proportion of participants achieving a low-density lipoprotein cholesterol (LDL-C) level below 70 mg/dL in each treatment group during follow-up.
Measured: 3 years
Proportion of participants achieving LDL-C <55 mg/dL in each group.
Proportion of participants achieving a low-density lipoprotein cholesterol (LDL-C) level below 55 mg/dL in each treatment group during follow-up.
Measured: 3 years
Proportion of participants crossing over to the non-assigned treatment group in each group.
Proportion of participants who crossed over from the assigned treatment group to the non-assigned treatment group during follow-up.
Measured: 3 years
New-onset diabetes mellitus.
Occurrence of new-onset diabetes mellitus during follow-up.
Measured: 3 years
New-onset diabetes mellitus requiring initiation of antidiabetic medication.
Occurrence of new-onset diabetes mellitus requiring initiation of antidiabetic medication during follow-up.
Measured: 3 years
Worsening glycemic control.
Occurrence of worsening glycemic control during follow-up
Measured: 3 years
Marked decline in kidney function
eGFR <10 mL/min/1.73 m², confirmed on at least two consecutive measurements during follow-up.
Measured: 3 years
Initiation of dialysis or kidney transplantation.
Initiation of maintenance dialysis or receipt of kidney transplantation during follow-up.
Measured: 3 years
Statin-associated muscle symptoms requiring a change in regimen or dose.
Occurrence of statin-associated muscle symptoms requiring a change in statin regimen or dose during follow-up.
Measured: 3 years
Rhabdomyolysis.
Occurrence of rhabdomyolysis during follow-up.
Measured: 3 years
Elevated creatine phosphokinase (CK >4 × the upper limit of normal)
Elevation of creatine phosphokinase greater than 4 times the upper limit of normal during follow-up.
Measured: 3 years
Elevated liver enzymes (AST and/or ALT ≥3 × the upper limit of normal)
Elevation of aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) equal to or more than 3 times the upper limit of normal during follow-up.
Measured: 3 years
Cancer diagnosis
New diagnosis of cancer during follow-up.
Measured: 3 years
Cataract surgery.
Occurrence of cataract surgery during follow-up.
Measured: 3 years
Hemorrhagic stroke.
Occurrence of hemorrhagic stroke during follow-up.
Measured: 3 years
Major bleeding (BARC type 2, 3, or 5 bleeding), assessed among participants who underwent percutaneous coronary intervention with new stent implantation at study enrollment.
Major bleeding defined as BARC type 2, 3, or 5 bleeding, assessed among participants who underwent percutaneous coronary intervention with new stent implantation at study enrollment.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start28 May 2026
- Primary completion22 Jan 2031 (estimated)
- Study completion22 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal InsufficiencyStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,952 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07524101
- Sponsor's protocol ID
- 4-2025-1647
- Status last verified
- Jun 2026
- First submitted
- 3 Apr 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilizing Lipid-lowering Therapy With Moderate-intensity Statin Plus Ezetimibe in Chronic Kidney Disease Patients With Concomitant Atherosclerotic Cardiovascular Disease: ULTRA-CKD Trial
- ClinicalTrials.gov ID
- NCT07524101
- Acronym / sponsor ID
- 4-2025-1647
- Conditions
- Renal Insufficiency, Atherosclerosis, Dyslipidemia, Hypercholesterolemia, Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,952 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 28 May 2026 (actual)
- Primary completion
- 22 Jan 2031 (estimated)
- Study completion
- 22 Jan 2031 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
All eligible patients with chronic kidney disease (CKD) and concomitant atherosclerotic cardiovascular disease (ASCVD) will be enrolled according to inclusion/exclusion criteria after voluntary agreement with informed consent.
At the time of enrollment, we will stratify the patients according to diabetes mellitus and dialysis status, and randomly assign them in two groups according to lipid-lowering regimen with a 1:1 ratio: "Moderate-intensity statin plus ezetimibe group" vs. "High-intensity statin monotherapy group".
In this study, the combination therapy strategy will utilize Pitavastatin 1-4 mg plus Ezetimibe 10 mg once daily or Atorvastatin 10-20 mg plus Ezetimibe 10 mg once daily. The monotherapy strategy will utilize Atorvastatin 40 mg once daily.
Study visits are scheduled at 4 weeks and at 6, 12, 18, 24, 30, and 36 months. The primary outcome is the composite of cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization. The key secondary outcome is CKD progression defined as a ≥40% decline in eGFR confirmed on at least two consecutive measurements
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate-intensity statin and ezetimibe combination therapy | Experimental | Drug: Moderate-intensity statin and ezetimibe combination therapyParticipants will receive moderate-intensity statin plus ezetimibe (pitavastatin 1-4 mg + ezetimibe 10 mg once daily or atorvastatin 10-20 mg + ezetimibe 10 mg once daily), with 36-month follow-up. |
| High-intensity statin monotherapy | Active comparator | Drug: High-intensity statin monotherapyParticipants will receive high-intensity statin monotherapy (atorvastatin 40 mg once daily), with 36-month follow-up. |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (6 listed)
- 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.
- Allergy or hypersensitivity to statins.
- Life expectancy <1 year.
- Expected inability to complete at least 1 year of follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moderate-intensity statin and ezetimibe combination therapyParticipants will receive moderate-intensity statin plus ezetimibe (pitavastatin 1-4 mg + ezetimibe 10 mg once daily or atorvastatin 10-20 mg + ezetimibe 10 mg once daily), with 36-month follow-up. | Drug | Moderate-intensity statin and ezetimibe combination therapy |
| High-intensity statin monotherapyParticipants will receive high-intensity statin monotherapy (atorvastatin 40 mg once daily), with 36-month follow-up. | Drug | High-intensity statin monotherapy |
Primary outcome
Major adverse cardiovascular events
Time frame: 3 years
Composite of cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization.
26 secondary outcomes
CKD progression
Time frame: 3 years
Cardiovascular death.
Time frame: 3 years
Myocardial infarction.
Time frame: 3 years
Stroke.
Time frame: 3 years
Hospitalization for unstable angina.
Time frame: 3 years
Coronary revascularization.
Time frame: 3 years
Composite of cardiovascular death, myocardial infarction, and stroke.
Time frame: 3 years
Composite of cardiovascular death, myocardial infarction, stroke, and hospitalization for unstable angina
Time frame: 3 years
Composite of cardiovascular death, myocardial infarction, stroke, and coronary revascularization.
Time frame: 3 years
Composite of all-cause death, myocardial infarction, stroke, hospitalization for unstable angina, and coronary revascularization.
Time frame: 3 years
Proportion of participants achieving the LDL-C <70 mg/dL in each group.
Time frame: 3 years
Proportion of participants achieving LDL-C <55 mg/dL in each group.
Time frame: 3 years
Proportion of participants crossing over to the non-assigned treatment group in each group.
Time frame: 3 years
New-onset diabetes mellitus.
Time frame: 3 years
New-onset diabetes mellitus requiring initiation of antidiabetic medication.
Time frame: 3 years
Worsening glycemic control.
Time frame: 3 years
Marked decline in kidney function
Time frame: 3 years
Initiation of dialysis or kidney transplantation.
Time frame: 3 years
Statin-associated muscle symptoms requiring a change in regimen or dose.
Time frame: 3 years
Rhabdomyolysis.
Time frame: 3 years
Elevated creatine phosphokinase (CK >4 × the upper limit of normal)
Time frame: 3 years
Elevated liver enzymes (AST and/or ALT ≥3 × the upper limit of normal)
Time frame: 3 years
Cancer diagnosis
Time frame: 3 years
Cataract surgery.
Time frame: 3 years
Hemorrhagic stroke.
Time frame: 3 years
Major bleeding (BARC type 2, 3, or 5 bleeding), assessed among participants who underwent percutaneous coronary intervention with new stent implantation at study enrollment.
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate-intensity statin and ezetimibe combination therapy and High-intensity statin monotherapy in people with Renal Insufficiency and Atherosclerosis, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jung-Sun Kim, Professor (+82-2-2228-8460, kjs1218@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiovascular events (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.