CTIS2022-501802-36-00招募中1 期
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 - ALXN1210-CSA-AKI-318
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 736
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •= 18 to = 90 years of age at the time of signing the informed consent., Male or female; Female participants of childbearing potential and male participants must follow protocol-specified contraception guidance., Body weight = 30 kg at Screening., Planned non-emergent cardiac surgery requiring CPB for the following procedures: 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 or apparent CKD (by history, diagnostic results, or reasonable medical assessment made by the Investigator and recorded in the medical record) and eGFR = 20 to < 60 mL/min/1.73 m2 using CKD-EPI equation by sCr or sCysC measurement, obtained by local or central laboratory during the 28 days prior to randomization, At risk for postsurgical kidney events as defined by a minimum STS Calculator Renal Failure Risk Score of = 2.8% assessed at time of screening., Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
排除标准
- •Emergency or salvage cardiac surgery is expected at screening or randomization, as assessed by the Investigator, History of unexplained, recurrent infection., 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., History of, or unresolved, N meningitidis infection, Hypersensitivity to any ingredient contained in the study intervention, including hypersensitivity to murine proteins., Current malignancy (excluding local or regional prostate cancer or non-melanoma skin cancer) or receiving treatment for malignancy, 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., Planned use of any pharmacologic agent specifically for prevention or treatment of AKI., Anticipated use of KRT, extracorporeal membrane oxygenation, or temporary cardiac support devices including left ventricular assist device between randomization and surgery. Elective or pre-emptive insertion of temporary cardiac support devices (including IABP) on the day of surgery is acceptable in the absence of cardiogenic shock or hemodynamic instability., 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 investigational product (IP), whichever is greater, or planned participation/use during the course of the study., Presence of a do-not-resuscitate order or life expectancy of < 3 months., Single-vessel CABG without valve surgery is planned., Pregnant, breastfeeding, or intending to conceive within 8 months after the dose of study intervention., Participant is not willing to be vaccinated against N meningitidis or is unwilling to receive prophylactic treatment with appropriate antibiotics, if needed, Off-pump surgery is planned (eg, surgery without CPB)., Any use of KRT or presence of AKI within 30 days prior to randomization (AKI defined as 1.5x increase in sCr over baseline), except transient (= 5 days) Stage 1 AKI after iodinated contrast exposure., Recipient of a solid organ or bone marrow transplantation., Cardiogenic shock or hemodynamic instability, including use of intra-aortic balloon pump (IABP) or other temporary cardiac output support device, extracorporeal membrane oxygenation (ECMO), or left ventricular assist device within 72 hours prior to randomization., Active systemic bacterial, viral, or fungal infection within 14 days prior to randomization., 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 prior to Screening., Congenital immunodeficiency.
研究者
相似试验
终止
3 期
ARTEMIS: Ravulizumab to Protect Patients With CKD From CSA-AKI and MAKECKDCardiac DiseaseCardiopulmonary BypassChronic Kidney DiseaseNCT05746559Alexion Pharmaceuticals, Inc.555
尚未招募
3 期
A Study of Ravulizumab to Protect Patients with Chronic Kidney Disease (CKD) from Cardiac Surgery Associated-Acute Kidney Injury and Major Adverse Kidney EventsCTRI/2024/05/067786Alexion Pharmaceuticals, Inc.,
招募中
3 期
A Phase 3 Study of Ravulizumab to Protect Patients with CKD from CSA-AKI and MAKEChronic Kidney DiseaseCKDCardiac DiseaseCardiopulmonary BypassCSA-AKIJPRN-jRCT2031230020Yokosawa Jun36
进行中（未招募）
1 期
Will a single dose of Rituximab treatment, when taken with anti thyroid drugs for 1 year, stop the over-activity of the thyroid gland from returning once you stop ATD treatment?EUCTR2016-000209-35-GBewcastle upon Tyne Hospitals NHS Foundation Trust27
进行中（未招募）
不适用
First line treatment with Rituximab asociated to CVP plus Interferon in Follicular Lymphoma. Phase II study.Asociación de Rituximab al esquema CVP + Interferón en el tratamiento de primera línea del linfoma folicular - R-CVP-IFEUCTR2005-004761-42-ESFundacion Leucemia y Linfoma