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Активно (без набиране) Фаза 3 NCT05746559

ARTEMIS: Ravulizumab to Protect Patients With CKD From CSA-AKI and MAKE

Фаза 3 – широко изпитване преди одобрение
Заболявания: Chronic Kidney Disease CKD Cardiac Disease Cardiopulmonary Bypass

Спонсор: Alexion Pharmaceuticals, Inc.

Налично на: БГ
Обобщение
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.
Кой може да участва
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.
Места на провеждане 20
Argentina (1)
Research Site
Buenos Aires
Австралия (1)
Research Site
Adelaide
Бразилия (1)
Research Site
Belo Horizonte
Канада (1)
Research Site
Edmonton , Alberta
Китай (1)
Research Site
Beijing
Франция (1)
Research Site
Bordeaux
Германия (1)
Research Site
Essen
Hong Kong (1)
Research Site
Hong Kong
Индия (1)
Research Site
Bangalore
Израел (1)
Research Site
Haifa
Италия (1)
Research Site
Bari
Япония (1)
Research Site
Bunkyō City
Нидерландия (1)
Research Site
Groningen
Полша (1)
Research Site
Bialystok
Южна Корея (1)
Research Site
Anyang-si
Испания (1)
Research Site
A Coruña
Taiwan (1)
Research Site
Hualien City
Турция (1)
Research Site
Ankara
Великобритания (1)
Research Site
Cambridge
САЩ (1)
Research Site
Tucson , Arizona
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
90 Years
Здрави доброволци
Не
Начална дата
06.04.2023
Крайна дата
17.02.2027
Регистрационен номер
NCT05746559
Източник
anzctr
Запитване за медицински туризъм

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