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New combo therapy could protect kidneys and hearts without High-Dose statins

NCT ID NCT07524101

Disease control Sponsor: Yonsei University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two cholesterol-lowering strategies in about 1,950 adults with chronic kidney disease and heart or blood vessel disease. One group gets a moderate-dose statin plus ezetimibe, the other gets a high-dose statin alone. The goal is to see if the combo is just as good at preventing heart attacks, strokes, and other major events, while being safer for the kidneys. Participants will be followed for three years.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 1,952 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Jan 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 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. 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 ≥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.

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Conditions

The condition(s) this trial relates to.

atherosclerosis atherosclerotic cardiovascular disease cardiovascular disorder chronic kidney disease Dyslipidemias Hypercholesterolemia hyperlipidemia inherited lipid metabolism disorder kidney failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atherosclerosis Cardiovascular diseases Dyslipidemia Hypercholesterolemia Renal insufficiency

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Severance Hospital

    RECRUITING

    Seoul, 03722, South Korea

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