Cardiac Disease, Cardiopulmonary Bypass, Chronic Kidney Disease, CKD
Conditions
Keywords
Chronic Kidney Disease, CKD, Cardiac Disease, Cardiopulmonary Bypass
Brief summary
The primary objective of this study is to assess the efficacy of a single dose of ravulizumab IV compared with placebo in reducing the risk of the clinical consequences of AKI (MAKE) at 90 days in adult participants with CKD who undergo non-emergent cardiac surgery with CPB.
Interventions
DRUGPlacebo
Participants will receive a single weight-based dose of placebo via intravenous infusion.
DRUGRavulizumab
Participants will receive a single weight-based dose of ravulizumab via intravenous infusion.
Sponsors
Alexion Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Participant weighs ≥ 30 kg * 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/repair * Combined CABG and valve surgery; inclusion of single-vessel CABG when combined with valve replacement/repair is permitted * Known CKD for at least 90 days (CKD Stage 3A, 3B, or 4)
Exclusion criteria
* Emergency or salvage cardiac surgery is expected at screening or randomization, as assessed by the investigator. * Single-vessel CABG without valve surgery is planned. * Off-pump surgery is planned (eg, surgery without CPB). * Recipient of a solid organ or bone marrow transplantation. * Cardiogenic shock, hemodynamic instability, use of intra-aortic balloon pump, extracorporeal membrane oxygenation, or left ventricular assist device within 72 hours of randomization. * Active systemic bacterial, viral, or fungal infection within 14 days prior to randomization. * History of unexplained, recurrent infection. * Any use of KRT or presence of AKI within 30 days of randomization * 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. * Participant is not willing to be vaccinated against N meningitidis or is unwilling to receive prophylactic treatment with appropriate antibiotics , if needed * History of or unresolved N meningitidis infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants Experiencing Major Adverse Kidney Events (MAKE) (Based on serum Cystatin C [sCysC]) at Day 90 Post Cardiopulmonary Bypass (CPB) | Day 90 post-CPB |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To assess the efficacy of ravulizumab in reducing risk of AKI (based on sCr) following CPB | Day 90 post CPB | 1. Occurrence of CSA-AKI without recovery at Day 90 post CPB 2. Occurrence of severe CSA-AKI (KDIGO Stage 2 or 3) from randomization to Day 7 post CPB 3. Occurrence of severe AKI (KDIGO Stage 2 or 3) from randomization to Day 30 post CPB 4. Occurrence of KRT or death from randomization to Day 90 post CPB 5. All-cause mortality from randomization to Day 90 post CPB 6. Length of post-operative ICU stay |
Countries
Argentina, Australia, Brazil, Canada, China, France, Germany, Hong Kong, India, Israel, Italy, Japan, Netherlands, Poland, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom, United States
Contacts
STUDY_DIRECTORTolga Baykal, MD, PhD
+34-609-454-477
Outcome results
None listed