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EXploring approaChEs for Lowering blood preSsure and lipid for ImprOving Renal outcome in advanced CKD (EXCELSIOR-CKD)

EXploring approaChEs for Lowering blood preSsure and lipid for ImprOving Renal outcome in advanced CKD (EXCELSIOR-CKD)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CRIS
Registry ID
KCT0010146
Enrollment
640
Registered
2025-01-22
Start date
2025-03-03
Completion date
Unknown
Last updated
2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug, Behavioral, Dietary Supplement : Study Interventions will be guided by the respective treatment recommendation algorithms in the choice of antihypertensive and lipid-lowering drugs, and will be

Sponsors

Yonsei University Health System, Severance Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime frame
renal composite outcome;AE,SAE, ADR, AESI(Adverse Event of Special Interest), Vital sign(BP, Pulse), Central Lab results

Secondary

MeasureTime frame
Individual components of renal composite outcome;Cardiovascular composite outcome;eGFR slopes

Countries

Korea, Republic of

Contacts

Public ContactSeung Hyeok Han

Yonsei University Health System, Severance Hospital

hansh@yuhs.ac+82-2-2228-5356

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026