A Phase 3 Study of Ravulizumab to Protect Patients with CKD from CSA-AKI and MAKE

Authors
Category Primary study
Registry of TrialsJapan Primary Registry Network
Year 2023
INTERVENTION: Participants will receive a single weight‐based dose of ravulizumab, via intravenous infusion, 1 to 7 days prior to surgery as below dosage regimen; In cae Patient Body Weight (kg) is 30 to 40: 2700mg, In cae Patient Body Weight (kg) is 40 to 60: 3000mg, In cae Patient Body Weight (kg) is 60 to 100: 3300mg, In cae Patient Body Weight (kg) is over 100: 3600mg CONDITION: Chronic Kidney Disease CKD Cardiac Disease Cardiopulmonary Bypass ; CSA‐AKI CSA‐AKI PRIMARY OUTCOME: 1.Number of Participants Experiencing Major Adverse Kidney Events (MAKE) (Based on serum Cystatin C [sCysC]) at Day 90 Post Cardiopulmonary Bypass (CPB) [ Time Frame: Day 90 post‐CPB ] SECONDARY OUTCOME: 1.Number of Participants Free From Cardiac Surgery‐Associated Acute Kidney Injury (CSA‐AKI) at Day 90 Post CPB [ Time Frame: Day 90 post‐CPB ]; 2.Number of Participants Free From Severe CSA‐AKI (Kidney Disease: Improving Global Outcomes [KDIGO] Stage 2 or 3) Based on Highest Observed Serum Creatinine (sCr) Within 7 Days Post CPB [ Time Frame: Baseline through Day 7 post‐CPB ]; 3.Number of Participants Free From Any Severe Acute Kidney Injury (AKI) (Risk, Injury, Failure, Loss of Kidney Function, and End‐Stage Kidney Disease [RIFLE] Injury or Failure Criteria) Based on Highest Observed sCr Within Day 30 Post CPB [ Time Frame: Baseline through Day 30 post‐CPB ]; 4.Number of Participants Free From Any Severe AKI (KDIGO Stage 2 or 3) Based on Highest Observed sCr Within Day 30 Post CPB [ Time Frame: Baseline through Day 30 post‐CPB ]; 5.Number of Participants Free From Any RIFLE Failure Criteria Based on Highest Observed sCr Within Day 30 Post CPB [ Time Frame: Baseline through Day 30 post‐CPB ]; 6.Number of Participants Who Experienced MAKE at Days 30, 60, and 90 (Excluding MAKE90 Based on sCysC) Post CPB [ Time Frame: Days 30, 60, and 90 post‐CPB ]; 7.Number of Participants Who Died or had Kidney Replacement Therapy (KRT) at Days 30, 60, and 90 Post CPB [ Time Frame: Days 30, 60, and 90 post‐CPB ]; 8.Number of Participants with the Highest CSA‐AKI Stage Within 3 and 7 Days Post CPB [ Time Frame: Baseline through Day 3 and Day 7 post‐CPB ]; 9.Number of Participants Free From CSA‐AKI at Days 15, 30, and 60 Post CPB [ Time Frame: Days 15, 30, and 60 post‐CPB ]; 10.Number of Participants Free From Any AKI at Days 3, 7, 15, 30, 60, and 90 Post CPB [ Time Frame: Days 3, 7, 15, 30, 60, and 90 post‐CPB ]; 11.Number of Participants with AKI Progression on Days 15, 30, 60, and 90 Post CPB for Those Experiencing CSA‐AKI Within 7 Days Post CPB [ Time Frame: Days 15, 30, 60, and 90 post‐CPB ] INCLUSION CRITERIA: 1. Participant weighs 30 kg more 2. Planned non emergent sternotomy with CPB procedure for the following surgeries, Multi vessel CABG Valve replacement or repair, ascending aorta surgery permitted if combined with aortic valve replacement or repair Combined CABG and valve surgery, inclusion of single‐vessel CABG when combined with valve replacement or repair is permitted 3. Known CKD (Stage 3A, 3B, or 4) for at least 3 months
Epistemonikos ID: 94541463ea39047d65488d43bcf45d7aa80cf83d
First added on: Aug 26, 2024