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

JRCT ID: jRCT2031230020

Registered date:16/04/2023

Basic Information

• Recruitment status: Recruiting

Health condition(s) or Problem(s) studied

Chronic Kidney Disease
CKD
Cardiac Disease
Cardiopulmonary Bypass

• Date of first enrollment: 06/04/2023
• Target sample size: 36
• Countries of recruitment: Argentina,Japan,Australia,Japan,Brazil,Japan,Canada,Japan,Germany,Japan,Israel,Japan,Italy,Japan,Korea,Japan,Poland,Japan,Spain,Japan,Taiwan,Japan,Turkey,Japan,United Kingdom,Japan,United States,Japan
• Study type: Interventional

Intervention(s)

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

Outcome(s)

• 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 ]

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 90age old
• Gender: Both

Include 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

Exclude criteria

1. Emergency or salvage cardiac surgery is expected at screening or randomization, as assessed by the Investigator.
2. Single-vessel CABG without valve surgery is planned.
3. Off-pump surgery is planned (eg, surgery without CPB).
4. Recipient of a solid organ or bone marrow transplantation.
5. Cardiogenic shock, hemodynamic instability, use of intra-aortic balloon pump, extracorporeal membrane oxygenation, or left ventricular assist device within 72 hours of randomization.
6. Active systemic bacterial, viral, or fungal infection within 14 days prior to randomization.
7. History of unexplained, recurrent infection.
8. Any use of KRT or presence of AKI within 30 days of randomization
9. Use of any complement inhibitors, or plasmapheresis or plasma exchange within the year prior to Screening, or planned use during the course of the study.
10. Participant is not willing to be vaccinated against N meningitidis or is unwilling to receive prophylactic treatment with appropriate antibiotics, if needed
11. History of or unresolved N meningitidis infection.

Related Information

• Primary Sponsor: Yokosawa Jun