An interventional study of Intensive control of SBP and intensive control of LDL-C and Intensive control of SBP and standard control of LDL-C in Chronic Kidney Diseases, Hypertension and Dyslipidemias, sponsored by Yonsei University. Recruiting at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2024-12-16.
Sponsored by Yonsei University · Not applicable, Interventional, and Treatment
The purpose of this study is to prevent kidney disease progression in adults with advanced chronic kidney disease (estimated glomerular filtration rate [eGFR] between 15-45 mL/min/1.73 m2) using intensive blood pressure control and intensive lipid management with 2X2 factorial design.
The EXploring approaChEs with Lower targets of blood preSsure and lIpid for impOving Renal outcome in advanced Chronic Kidney Disease (EXCELSIOR-CKD) strived to enroll about 642 participants aged ≥19 years with eGFR 15-45 mL/min/1.73 m2, systolic blood pressure (SBP) ≥130 mmHg, and low-density lipoprotein cholesterol (LDL-C) ≥100 mg/dL.
The EXCELSIOR-CKD study is a 2X2 factorial design with factors consisting of: intensive versus standard SBP control (120 vs 140 mmHg), and intensive versus standard LDL-C control (70 vs 100 mg/dL).
The primary hypothesis was that kidney disease progression event rates would be lower in the intensive arms. Participants would be recruited at 13 clinics over approximately a 2-year period, and are planned to be followed for 3 years.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's planned enrollment of 642 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Fulfillment of all of followings
SBP of
Exclusion Criteria:
Any of followings
Resistant hypertension or poorly controlled hypertension
Using any drugs as followings:
Targeting SBP \<120 mmHg and targeting LDL-C \<70 mg/dL
Drug: Intensive control of SBP and intensive control of LDL-C
Targeting SBP \<120 mmHg and targeting LDL-C \<100 mg/dL
Drug: Intensive control of SBP and standard control of LDL-C
Targeting SBP \<140 mmHg and targeting LDL-C \<70 mg/dL
Drug: Standard control of SBP and intensive control of LDL-C
Targeting SBP \<140 mmHg and targeting LDL-C \<100 mg/dL
Drug: Standard control of SBP and standard control of LDL-C
Eligible participants would be assigned to a SBP target of less than 120 mmHg and a LDL-C target of less than 70 mg/dL.
Eligible participants would be assigned to a SBP target of less than 120 mmHg and a LDL-C target of less than 100 mg/dL.
Eligible participants would be assigned to a SBP target of less than 140 mmHg and a LDL-C target of less than 70 mg/dL.
Eligible participants would be assigned to a SBP target of less than 140 mmHg and a LDL-C target of less than 100 mg/dL.
Renal composite outcome
Renal composite outcome would be defined as one of followings: 1. A sustained decline in eGFR of 40%, 2. Initiation of kidney replacement therapy (dialysis or kidney transplantation), 3. A sustained eGFR \<10 mL/min/1.73 m2, or 4. Death from renal causes
Time frame: up to 3 years
Individual components of renal composite outcome
1. A sustained decline in eGFR of 40% 2. Initiation of kidney replacement therapy (dialysis or kidney transplantation), 3. A sustained eGFR \<10 mL/min/1.73 m2 4. Death from renal causes 5. Rate of change of eGFR during chronic phase I (12 week to 3 year) 6. Rate of change of eGFR during chronic phase II (24 week to 3 year) 7. Rate of change of eGFR during study period (0 week to 3 year) 8. Cardiovascular composite outcome (defined as one of followings): 1. Death from cardiovascular causes, 2. Non-fatal myocardial infarction, 3. Non-fatal stroke (ischemic or hemorrhagic), 4. Hospitalization for heart failure, or 5. Revascularization (coronary, carotid, or peripheral artery)
Time frame: up to 3 years
eGFR slopes
1. A sustained decline in eGFR of 40% 2. Initiation of kidney replacement therapy (dialysis or kidney transplantation), 3. A sustained eGFR \<10 mL/min/1.73 m2 4. Death from renal causes 5. Rate of change of eGFR during chronic phase I (12 week to 3 year) 6. Rate of change of eGFR during chronic phase II (24 week to 3 year) 7. Rate of change of eGFR during study period (0 week to 3 year) 8. Cardiovascular composite outcome (defined as one of followings): 1. Death from cardiovascular causes, 2. Non-fatal myocardial infarction, 3. Non-fatal stroke (ischemic or hemorrhagic), 4. Hospitalization for heart failure, or 5. Revascularization (coronary, carotid, or peripheral artery)
Time frame: up to 3 years
Cardiovascular composite outcome
1. A sustained decline in eGFR of 40% 2. Initiation of kidney replacement therapy (dialysis or kidney transplantation), 3. A sustained eGFR \<10 mL/min/1.73 m2 4. Death from renal causes 5. Rate of change of eGFR during chronic phase I (12 week to 3 year) 6. Rate of change of eGFR during chronic phase II (24 week to 3 year) 7. Rate of change of eGFR during study period (0 week to 3 year) 8. Cardiovascular composite outcome (defined as one of followings): 1. Death from cardiovascular causes, 2. Non-fatal myocardial infarction, 3. Non-fatal stroke (ischemic or hemorrhagic), 4. Hospitalization for heart failure, or 5. Revascularization (coronary, carotid, or peripheral artery)
Time frame: up to 3 years
Plan to share: No
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