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Clinical Trial Details

Trial ID: L0258
Source ID: NCT06322056
Associated Drug: Intensive Control Of Sbp And Intensive Control Of Ldl-C
Title: Exploring Approaches With Lower Targets of Blood Pressure and Lipid for Improving Renal Outcome in Advanced Chronic Kidney Disease
Acronym: EXCELSIOR-CKD
Status: RECRUITING
Study Results: NO
Results:
Conditions: Chronic Kidney Diseases|Hypertension|Dyslipidemias
Interventions: DRUG: Intensive control of SBP and intensive control of LDL-C|DRUG: Intensive control of SBP and standard control of LDL-C|DRUG: Standard control of SBP and intensive control of LDL-C|DRUG: Standard control of SBP and standard control of LDL-C
Outcome Measures: Primary: 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, up to 3 years | Secondary: 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), 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), 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), up to 3 years
Sponsor/Collaborators: Sponsor: Yonsei University
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 642
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-13
Completion Date: 2029-08-31
Results First Posted:
Last Update Posted: 2024-12-16
Locations: Severance Hospital, Seoul, 03722, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT06322056