A Randomised Placebo-Controlled Trial to Investigate the Effect of Pre-treatment With Haem Arginate (Normosang) on Heme-Oxygenase 1 (HO-1) Upregulation in Recipients of Deceased Donor Kidneys
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Macrophage/monocyte HO-1 protein levels
研究概览
简要总结
This is a blinded, placebo-controlled, randomised controlled trial looking at the effects of Heme arginate (HA) on cadaveric renal transplantation. The investigators know that HA can upregulate HO-1, which has been shown to have a protective effect on animal transplants.
The investigators will be giving HA/placebo to participants prior to transplant and repeat again on day 2 post-transplant and compare outcomes.
详细描述
Patients will be recruited from the East of Scotland transplant waiting list and consent when they arrive in the hospital. The investigators will randomise them to drug or placebo and give the infusion prior to induction for their transplant.
A blood sample will be taken prior to infusion and a renal biopsy will be taken before the graft is implanted. These will be used as baseline values.
Patients will receive standard care from our unit. The investigators will use the routine blood test results (urea and creatinine) to determine the function of the graft.
The investigators will take blood samples 24 hours after infusion of drug/placebo and use this to determine the primary outcome. Blood tests will be taken daily and a renal biopsy taken on day 5 to fulfil secondary objectives.
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
- Triple (Participant, Care Provider, 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
- •all patients receiving a cadaveric single kidney transplant
- •patients on a standard immunosuppressive regime
排除标准
- •patients on different immunosuppressives
- •patients receiving 3rd or subsequent kidney transplant
- •patients are fully anti-coagulated
- •patients unable to take Heme Arginate
- •patients unable to give informed consent
- •patients on combined anti-platelet agents
研究组 & 干预措施
Heme arginate (Normosang)
This arm will receive 2 doses of Heme Arginate (trade name Normosang); 1 dose prior to transplant and another on day 2. This is a product derived from human hemin and has been used for over 20 years in clinical practice with few side-effects.
干预措施: Heme arginate (Normosang) (Drug)
0.9% saline
The saline will be given as an IV infusion in the same manner as the Heme Arginate (active comparator) infusion.
干预措施: 0.9% sodium chloride (Drug)
结局指标
主要结局
Macrophage/monocyte HO-1 protein levels
时间窗: 24 hours
We will measure the level of HO-1 protein in isolated macrophages/ monocytes in a peripheral blood sample taken at 24 hours after drug infusion
次要结局
- Urinary biomarkers as markers of injury(daily for 5 days)
- Macrophage/monocyte HO-1 mRNA levels(24 hours)
- HO-1 protein in kidney transplant(5 days)
- Effect on transplanted kidney function(daily for 5 days)