NCT02145182已完成2 期
A Randomized, Parallel-group, Double-blind, Placebo-controlled, Multi-center Study of Eculizumab for the Prevention of Delayed Graft Function After Kidney Transplantation in Adult Subjects at Increased Risk of Delayed Graft Function.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 288
- 试验地点
- 1
- 主要终点
- Percentage Of Participants With Delayed Graft Function (DGF) In The First Seven Days Post-transplant
研究概览
简要总结
The purpose of this study was to determine if eculizumab is safe and could be used to prevent delayed graft function (DGF) following kidney transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 18 years or older
- •Has dialysis-dependent renal failure (initiated more than 2 months prior to transplant)
- •Participant is to receive a first kidney transplant from a standard criteria donor or expanded criteria donor deceased donor with a DGF risk score using the Irish scale of ≥25% (to be determined prior to surgery and before randomization)
- •Able to provide written informed consent
- •Willing and able to comply with the requirements of the study protocol
- •Female participants of child-bearing potential must have a negative serum pregnancy test (serum beta-human chorionic gonadotropin) and must be practicing an effective, reliable, and medically approved contraceptive regimen at the time of consent and for up to 5 months following discontinuation of treatment
排除标准
- •Participant to receive a multi-organ transplant
- •Participant to receive kidney(s) from donors <6 years of age
- •Participant to receive a dual kidney transplant (from same donor, including en bloc)
- •Participant to receive a living donor kidney
- •Participant is highly sensitized (high risk to develop acute antibody-mediated rejection) to the donor (as determined by local center practice). Testing to determine high risk may include but is not limited to flow cytometric cross match, single antigen bead testing and/or complement dependent cytotoxicity
- •Participant has received a previous transplant
- •Participant is participating in another investigational study
- •Participant has a body mass index >40 kilograms/square meter at screening
- •Participant will be the recipient of an A, B, O Blood Glycoproteins (ABO) (blood type) incompatible kidney (A2 donors to B and O recipients will be allowed if the site has the ability to confirm A2 subtype)
- •Participant will receive a kidney from a donation after cardiac death donor
- •Participant has a predicted Irish model risk of DGF <25%
- •Female participants who are pregnant or breast feeding
- •Female participants of child bearing potential who are unable or unwilling to use a medically acceptable form of contraception
- •Participants with a history of human immunodeficiency virus, or active hepatitis C virus or hepatitis B virus infection
- •Participants with active bacterial or other infection which is clinically significant in the opinion of the Investigator
- •Participants with a history of splenectomy
- •Participants with unresolved meningococcal disease
- •Participants with an unresolved systemic bacterial or fungal infection
- •Participants with known or suspected hereditary complement deficiency (for example, but not limited to: atypical hemolytic uremic syndrome, paroxysmal nocturnal hemoglobinuria)
- •Participant has a current malignancy or a history of any malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix that has been treated appropriately
- •Participant has a history of or is believed by the Investigator to have used an illicit drug(s) and/or abused alcohol within 3 months prior to screening
- •Participant has a psychiatric or physical illness that in the opinion of the Investigator would interfere with the ability of the participant to participate in the study
研究组 & 干预措施
Active
Experimental
Eculizumab was administered by intravenous (IV) infusion over 25-45 minutes (min) for 2 doses (on the day of transplant then 18-24 hours [h] later).
干预措施: Eculizumab (Drug)
Placebo
Placebo Comparator
Placebo was administered by IV infusion over 25-45 min for 2 doses (on the day of transplant then 18-24 h later).
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage Of Participants With Delayed Graft Function (DGF) In The First Seven Days Post-transplant
时间窗: First 7 days post transplantation
Results are reported for the DGF composite endpoint, defined as the occurrence of DGF (dialysis for any reason in the first 7 days post transplantation), graft loss, death, or loss to follow-up (including discontinuation) in the first 7 days post transplantation and for each item of the composite endpoint. Loss to follow-up included withdrawal due to any reason other than death. The sum of the counts in the events that make up the DGF composite may be greater than the composite count, because a participant who experienced multiple events was only counted once in the composite.
次要结局
- Percentage Of Participants With DGF, Functional DGF, And Immediate Graft Function(First 7 days post transplantation)
- Percentage Of Participants Who Required Dialysis Post Transplantation(First 30 days post transplantation)
- Estimated Glomerular Filtration Rate (eGFR)(Day 28 post transplantation)
- Percentage Of Participants With Rejection-free Graft Survival(Week 26 and 52 post transplantation)
研究者
研究点 (1)
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