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

Phase 3

Recruiting

• Conditions: Chronic Kidney DiseaseCKDCardiac DiseaseCardiopulmonary Bypass; CSA-AKI

• Registration Number: JPRN-jRCT2031230020
• Lead Sponsor: Yokosawa Jun

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-04-16
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 36

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

Exclusion 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 ]