NCT07524101

Brief 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 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,952

participants targeted

Target at P75+ for not_applicable

Timeline
57mo left

Started Jun 2026

Longer than P75 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 3, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2031

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2031

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

4.6 years

First QC Date

April 3, 2026

Last Update Submit

April 3, 2026

Conditions

HypercholesterolemiaAtherosclerosisCardiovascular DiseasesRenal InsufficiencyDyslipidemia

Outcome Measures

Primary Outcomes (1)

  • Major adverse cardiovascular events

    Composite of cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization.

    3 years

Secondary Outcomes (1)

  • CKD progression

    3 years

Study Arms (2)

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.

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.

Drug: High-intensity statin monotherapy

Interventions

Moderate-intensity statin and ezetimibe combination therapyDRUG

Participants will receive moderate-intensity statin plus ezetimibe (pitavastatin 4 mg + ezetimibe 10 mg once daily or atorvastatin 20 mg + ezetimibe 10 mg once daily), with 36-month follow-up.

Moderate-intensity statin and ezetimibe combination therapy
High-intensity statin monotherapyDRUG

Participants will receive high-intensity statin monotherapy (atorvastatin 40 mg once daily), with 36-month follow-up.

High-intensity statin monotherapy

Eligibility Criteria

Age19 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Renal InsufficiencyAtherosclerosisDyslipidemiasHypercholesterolemiaCardiovascular Diseases

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHyperlipidemias

Central Study Contacts

Jung-Sun Kim, Professor

CONTACT

+82-2-2228-8460kjs1218@yuhs.ac

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2026

First Posted

April 13, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

January 22, 2031

Study Completion (Estimated)

January 22, 2031

Last Updated

April 13, 2026

Record last verified: 2026-04