Evaluation of a Marine OXYgen Carrier for Organ Preservation : a Multicenter Randomized Study Evaluating the Efficacy of HEMO2life® Versus Standard of Care in Renal Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 490
- 试验地点
- 32
- 主要终点
- Efficacy of HEMO2life® as an additive to standard organ preservation solution to prevent delayed graft function following renal transplantation.
研究概览
简要总结
Preventing ischemia/reperfusion injuries (IRIs) is a major issue in kidney transplantation, particularly for transplant recipients receiving a kidney from extended criteria donors (ECD). The main consequence of IRIs is delayed graft function (DGF).
The medical device HEMO2life®, an oxygen carrier developed by the Hemarina French Company, is a natural extracellular hemoglobin (Hb) isolated from the marine lugworm Arenicola marina. This biopolymer of high molecular weight (~3,600 kDa) has a large oxygen binding capacity, carrying up to 156 oxygen molecules when saturated (4 for human Hb). It releases oxygen according to a simple gradient and exhibits an intrinsic superoxide dismutase-like activity preventing both the occurrence of potentially harmful heme-protein-associated free radical species and the release of Hb degradation products.
Recently a safety study in 60 renal grafts using HEMO2life® as additive to organ preservation solution (Oxyop study, NCT02652520) was completed, that confirmed that the use of HEMO2life® is safe for patients and grafts.
In the Oxyop study, even if the protocol was not designed to show a benefit of the use of HEMO2life®, significantly less delayed graft function (DGF) and a shorter renal function recovery was observed.
The present research focuses on the efficacy of HEMO2life®, which is an oxygen carrier added in preservation solution in 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
- Other
- 盲法
- Single (Participant)
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
- •For Kidney graft:
- •Any pair of kidneys retrieved in an adult donor in one of first line participating centers.
- •Any pair of kidneys from a deceased donor after brain or cardiac death
- •For Patient:
- •Male or female renal allograft recipients at least 18 years old
- •Patient who signed an inform consent form
- •Patient receiving one graft from an included pair of kidneys
排除标准
- •For kidney :
- •Graft from a living donor
- •Graft dedicated to a multi-organ transplantation or dual kidney transplantation,
研究组 & 干预措施
HEMO2life
HEMO2life® will be used for ex vivo graft preservation at the dose of 1g per liter of preservation solution.
干预措施: Kidney transplant (Procedure)
Control
Organ preserved in preservation solution routinely used according to the local practice
干预措施: Kidney transplant (Procedure)
结局指标
主要结局
Efficacy of HEMO2life® as an additive to standard organ preservation solution to prevent delayed graft function following renal transplantation.
时间窗: From day 0 to day 7
Delayed graft function defined as the requirement for dialysis during the first week after transplantation will be compared as per the confirmatory testing strategy
次要结局
- Efficacy of HEMO2life® on renal parameters compared with standard of care(From month 0 to month 12)
- Efficacy in specific populations depending on type of donors and the type of preservation solution.(From month 0 to month 12)
- Evaluate the impact of HEMO2Life® on the degree and progression of interstitial fibrosis on the pre-implantation and 3 month biopsies(biopsies pre-implantation and month 3)
- Evaluate the impact of HEMO2life® on quality of life following renal transplant at Month-1, 3 and 12.(From Day 0 to month 12)
- Assess and compare graft and patient survival in the two groups.(From month 0 to month 12)
- Safety profile of HEMO2life® post transplant(From organ preservation to month 12)