Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-24 @ 11:34 PM
NCT ID:
NCT06322056
Eligibility Criteria:
Inclusion Criteria:
* Fulfillment of all of followings
1. At least 19 years old
2. Evidence of CKD defined at least 3 months before and at the time of screening visit with CKD-EPI eGFR ≥15 to \<45 mL/min/1.73 m2
3. SBP of
* 130-180 mmHg on 0 or 1 medication
* 130-170 mmHg on upto 2 medications
* 130-160 mmHg on more than 3 medications
4. LDL-C ≥100 mg/dL
Exclusion Criteria:
* Any of followings
1. Resistant hypertension or poorly controlled hypertension
* Failure to achieve SBP of \<140 mmHg despite using 4 or more antihypertensive medications including diuretics
2. Known secondary cause of hypertension
3. History of renal devervation procedure
4. Glomerulonephritis requiring immunosuppresive agents
5. Autosomal dominant polycystic kidney disease receiving tolvaptan
6. CKD-EPI \< 15 mL/min/1.73 m2 or receiving kidney replacement therapy
7. Familial hypercholesterolemia
8. Cardiovascular event or precedure (as defined as myocardial infarction, unstable angina, coronary revascularization, or stroke) within last 3 months or planning to cardiovascular procedure upcoming 3 months at the time of screening visit
9. Symptomatic heart failure within 6 months of left ventricular ejection fraction \<45%
10. A medical condition likely to limit survival to less thant 3 years
11. Diagnosis of malignancy within the last 5 years or undergoing chemotherepy or radiotherapy
12. Any organ transplant
13. Advanced cirrhosis (Child-Pugh class B or C) or abnormal liver function test (alanine transaminase or aspartate transaminase ≥1.5 X upper normal limit)
14. Evidence of active inflammatory muscle disease (polymyositis or dermatomyositis) or creatine kinase elevation (≥3 X upper normal limit)
15. History of adverse reaction to HMG-CoA reductase inhibitors or ezetimibe
16. Using any drugs as followings:
* Nicotinic acid
* Macrolide antibiotics
* Systemic imidazole or triazole antifungal agent
* Protease inhibitor
* Nefazodone
* Immunosuppressive agents (glucocorticoid \[equivalent to prednisone 10 mg/day over 4 weeks\], cyclosporin, mycofenolate, azathioprine, methotrexate, cyclophosphamide, or rituximab)
17. Pregnancy or trying to become pregnant
18. Diabetes mellitus, type I
19. Diabetes mellitus, type II with HbA1c ≥10.0%
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT06322056
Study Brief:
Protocol Section:
NCT06322056