ARTEMIS: RAvulizumab to PRotect PaTients With Chronic Kidney DisEase (CKD) froM Cardiac Surgery Associated Acute Kidney Injury (CSA-AKI) and Subsequent Major Adverse Kidney Events (MAKE): A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT05746559Tipo: INTERVENTIONALInicio: 6 de abr de 2023Fin estimado: 17 de feb de 2027

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 90 YearsSexo: ALL

Criterios de inclusión

Multi-vessel CABG
Participant weighs ≥ 30 kg
Planned non-emergent sternotomy with CPB procedure for the following surgeries:
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)

Criterios de exclusión

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.

Intervenciones

drug

Placebo

Participants will receive a single weight-based dose of placebo via intravenous infusion.

drug

Ravulizumab

Participants will receive a single weight-based dose of ravulizumab via intravenous infusion.

Ubicaciones

Research Site

Buenos Aires, Argentina

Research Site

Ciudad de Buenos Aires, Argentina

Research Site

Ciudad de Buenos Aires, Argentina

Research Site

Corrientes, Argentina

Research Site

Santa Fe, Argentina

Patrocinadores

PrincipalAlexion Pharmaceuticals, Inc.

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