A Study of Ravulizumab to Protect Patients with Chronic Kidney Disease (CKD) from Cardiac Surgery Associated-Acute Kidney Injury and Major Adverse Kidney Events

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Greater than or equal to 18 to less than or equal to 90 years of age at the time of signing the informed consent.

2.Male or female.

3.Body weight greater than or equal 30 kg at Screening.

4.Planned non-emergent sternotomy with CPB procedure for the following surgeries

i. Multi-vessel CABG

ii. Valve replacement or repair; ascending aorta surgery permitted if combined with aortic valve replacement or repair

iii. Combined CABG and valve surgery; inclusion of single-vessel CABG when combined with valve replacement or repair is permitted.

5.Known CKD for at least 90 days with eGFR Greaterthan or equal to 20 to less than 60 mL min 1.73 m2 CKD Stage 3A, 3B, or 4 at Screening

6.At risk for postsurgical AKI as defined by a minimum STS Calculator Renal Failure Risk Score of 3 percentage assessed at time of screening.

7.Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol

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.Any use of KRT or presence of AKI within 30 days of randomization (AKI defined as 1.5× increase in sCr over baseline), except transient (less than or equal to 5 days) Stage 1 AKI after iodinated contrast exposure

5.Recipient of a solid organ or bone marrow transplantation.

6.Cardiogenic shock, hemodynamic instability, use of intra-aortic balloon pump (IABP), extracorporeal membrane oxygenation, or left ventricular assist device within 72 hours of randomization.

7.Active systemic bacterial, viral, or fungal infection within 14 days prior to randomization.

8.Participants with history of human immunodeficiency virus (HIV) who are not on anti- retroviral therapy or if on therapy have a known detectable viral load within 1 year of Screening

9.Congenital immunodeficiency.

10.History of unexplained, recurrent infection.

11.Known medical or psychological condition(s), including substance abuse, or risk factor that, in the opinion of the Investigator, might interfere with the participant s full participation in the study, pose any additional risk for the participant, or confound the assessment of the participant or outcome of the study.

12.History of, or unresolved, N meningitidis infection.

13.Hypersensitivity to any ingredient contained in the study intervention, including hypersensitivity to murine proteins.

14.Current malignancy or receiving treatment for malignancy except for non-melanoma skin cancer.

15.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

16.Planned use of any pharmacologic agent specifically for prevention or treatment of AKI

17.Planned use of KRT, IABP, extracorporeal membrane oxygenation, or left ventricular assist device between randomization and surgery.

18.Participation in another interventional treatment study or use of any experimental therapy within 30 days before initiation of study intervention on Day 1 in this study or within 5 half lives of that IP, whichever is greater, or planned participation use during the course of the study.

19.Presence of a do-not-resuscitate order or life expectancy of less than 3 months

20.Pregnant, breastfeeding, or intending to conceive within 8 months after the dose of study intervention.

21.Participant is not willing to be vaccinated against N meningitidis or is unwilling to receive prophylactic treatment with appropriate antibiotics

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the efficacy of ravulizumab in reducing risk of MAKE90 following CPB <br/ ><br>Adult participants with CKD as defined by the inclusion and exclusion criteria <br/ ><br>Timepoint: To assess the efficacy of ravulizumab in reducing risk of MAKE90 following CPB at DAY 90 post CPB. <br/ ><br> <br/ ><br>

Secondary Outcome Measures