An interventional study of Moderate-intensity statin and ezetimibe combination therapy and High-intensity statin monotherapy in Renal Insufficiency, Atherosclerosis and Dyslipidemia, sponsored by Yonsei University. Recruiting at 1 site in South Korea. Open to participants aged 19 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-06-16.
Sponsored by Yonsei University · Not applicable, Interventional, and Treatment
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.
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
1,409 studies on the registry are indexed under Renal Insufficiency; 143 are open to participants now.
This study's planned enrollment of 1,952 is above the median of 40 across 1,058 interventional studies indexed under Renal Insufficiency.
Browse Renal Insufficiency studies →Yonsei University is the lead sponsor of 1,418 studies on the registry; 241 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Established ASCVD, meeting at least one of the following:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Moderate-intensity statin and ezetimibe combination therapy
Participants will receive high-intensity statin monotherapy (atorvastatin 40 mg once daily), with 36-month follow-up.
Drug: High-intensity statin monotherapy
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.
Participants will receive high-intensity statin monotherapy (atorvastatin 40 mg once daily), with 36-month follow-up.
Major adverse cardiovascular events
Composite of cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization.
Time frame: 3 years
CKD progression
CKD progression: ≥40% decline in eGFR from baseline, confirmed on at least two consecutive measurements during follow-up.
Time frame: 3 years
Cardiovascular death.
Death due to cardiovascular causes during follow-up.
Time frame: 3 years
Myocardial infarction.
Occurrence of myocardial infarction during follow-up.
Time frame: 3 years
Stroke.
Occurrence of stroke during follow-up
Time frame: 3 years
Hospitalization for unstable angina.
Hospitalization due to unstable angina during follow-up.
Time frame: 3 years
Coronary revascularization.
Any coronary revascularization procedure, including percutaneous coronary intervention or coronary artery bypass graft surgery, during follow-up.
Time frame: 3 years
Composite of cardiovascular death, myocardial infarction, and stroke.
First occurrence of cardiovascular death, myocardial infarction, or stroke during follow-up.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3 years
New-onset diabetes mellitus.
Occurrence of new-onset diabetes mellitus during follow-up.
Time frame: 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.
Time frame: 3 years
Worsening glycemic control.
Occurrence of worsening glycemic control during follow-up
Time frame: 3 years
Marked decline in kidney function
eGFR \<10 mL/min/1.73 m², confirmed on at least two consecutive measurements during follow-up.
Time frame: 3 years
Initiation of dialysis or kidney transplantation.
Initiation of maintenance dialysis or receipt of kidney transplantation during follow-up.
Time frame: 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.
Time frame: 3 years
Rhabdomyolysis.
Occurrence of rhabdomyolysis during follow-up.
Time frame: 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.
Time frame: 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.
Time frame: 3 years
Cancer diagnosis
New diagnosis of cancer during follow-up.
Time frame: 3 years
Cataract surgery.
Occurrence of cataract surgery during follow-up.
Time frame: 3 years
Hemorrhagic stroke.
Occurrence of hemorrhagic stroke during follow-up.
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.
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.
Time frame: 3 years
Plan to share: Undecided
No publications or documents are linked to this record.
Started May 2026 (actual). Primary completion is estimated for Jan 2031, 55 months after the start.
Of 118 non-industry interventional studies with no phase under Renal Insufficiency, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 49. This study's planned 55 months is above that.
Counting every sponsor, half of 149 studies reached it within 22 months; a quarter within 8 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
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