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New treatment option for Renal Insufficiency
Official title Moderate-Intensity Statin Plus Ezetimibe in CKD and ASCVD
ClinicalTrials.gov ID: NCT07524101
What this study is testing
What is Moderate-intensity statin and ezetimibe combination therapy?
Moderate-intensity statin and ezetimibe combination therapy is an investigational medicine, given as an once-daily, being studied as a potential treatment for renal insufficiency.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 to 85
You may be able to join 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.
You likely can't join 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.
See the full eligibility criteria
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.