None listed
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria: 1. Resistant hypertension or poorly controlled hypertension : Failure to achieve SBP of 6 months) remission that does not require immunosuppression and are judged to be unlikely to relapse. - Patients with progression of chronic kidney disease during conservative treatment, excluding immunosuppressive therapy. - Patients who have used immunosuppressive agents as topical steroids (intranasal spray, inhalation, intra-articular injection, or skin application) 5. Autosomal dominant polycystic kidney disease receiving tolvaptan 6. Diabetes mellitus, type I 7. Evidence of active inflammatory muscle disease 8. The screening results fall under the following: - CKD-EPI < 15 mL/min/1.73 m2 or end stage renal disease requiring renal replacement therapy as determined by the investigator - Abnormal liver function test (alanine transaminase or aspartate transaminase =1.5 X upper normal limit) - Creatine kinase level is more than 3 times the upper limit of normal. - Diabetes mellitus, type II with HbA1c =10.0% 9. Confirmed history of any of the following, regardless of duration - Renal sympathectomy - Advanced cirrhosis (Child-Pugh class B or C) (However, a history of hepatitis is not an exclusion criterion if the screening test results show that the ALT or AST level is less than 1.5 times the upper limit of normal). - History of adverse reaction to HMG-CoA reductase inhibitors or ezetimibe 10. Any organ transplant 11. History of dialysis due to acute deterioration of renal function within 3 months prior. 12. History of myocardial infarction, unstable angina pectoris, coronary revascularization, or cerebrovascular death within 3 months 13. History of symptomatic heart failure within 6 months or a result of left ventricular ejection fraction less than 45%. 14. History of malignancy undergoing chemotherapy or radiation therapy within 5 years. 15. Using any drugs as followings: o Nicotinic acid o Macrolide antibiotics o Systemic imidazole or triazole antifungal agent o Protease inhibitor o Nefazodone o Immunosuppressive agents (glucocorticoid [equivalent to prednisone 10 mg/day over 4 weeks], cyclosporin, mycofenolate, azathioprine, methotrexate, cyclophosphamide, or rituximab) 16. With a life expectancy of less than 3 years as determined by the Investigator 17. Pregnancy or trying to become pregnant 18. Other subjects judged by the investigator to have difficulty participating in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| renal composite outcome;AE,SAE, ADR, AESI(Adverse Event of Special Interest), Vital sign(BP, Pulse), Central Lab results | — |
Secondary
| Measure | Time frame |
|---|---|
| Individual components of renal composite outcome;Cardiovascular composite outcome;eGFR slopes | — |
Countries
Korea, Republic of
Contacts
Yonsei University Health System, Severance Hospital