Heme Arginate in Transplantation Study - a Multi-centre Blinded Parallel-group Randomised Trial of Heme Arginate Versus Placebo to Reduce Delayed Graft Function in Kidney Transplant Recipients
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Delayed Graft Function
研究概览
简要总结
Organ shortage for transplant has necessitated use of kidneys from older donors, increasing the chance that the kidney will not work immediately or for as long as expected. The investigators gave the drug heme arginate (HA) to 20 kidney transplant patients in the first 24 hours after transplant, and showed that it may reduce kidney injury and is safe. The investigators plan to conduct a large study recruiting 600 patients to determine whether HA treatment increases the number of kidney transplants that work immediately. If successful, HA may be introduced into clinical practice at the end of this study.
Patients will be invited to take part in the study once listed for a kidney transplant. Further discussions will be had with them when admitted for transplant, and they will be offered the opportunity to participate. Consent will not be taken until the patient is admitted for transplantation. Following consent, participants will be randomised to receive either 2 doses of the study drug, HA, or a salt water solution, one at the time of transplant, and one approximately 24 hours later. Otherwise, treatment will be the same as any other patient undergoing a kidney transplant. Information about recovery from surgery, and specifically about kidney function, will be collected, but will not require additional blood tests. The study period ends after the first 7 days post-transplant, although longer term data will be collected from routine follow up appointments. Participants will be asked to complete a simple quality of life questionnaire 3 times: just before transplant, at approximately one week and three months after transplant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
There will be an unblinded member of the research team (the individual administering the intervention) but otherwise the participant, the other members of the research team, the clinical team and blinded assessors will be blinded to the intervention.
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
- •Patients undergoing a kidney only transplant, or a dual kidney transplant, from a deceased donor
- •At least 18 years of age, no upper limit
- •Receiving standard immunosuppression for the individual centre
- •(where applicable) Meets co-enrolment criteria outlined in section 4.4 of the protocol
排除标准
- •Kidney transplant patients as part of a multi-organ transplant e.g. with pancreas or liver
- •Known hypersensitivity to heme arginate
- •Unable to give informed consent
- •Patients with porphyria, irrespective of whether they have received heme arginate or not, will be excluded
- •Previous randomisation into this study (or HOT study)
- •Women who are pregnant or lactating
- •Kidneys that have undergone Ex-vivo Normothermic Perfusion (EVNP)
- •Patients with known liver disease, epilepsy, brain injury or disease
研究组 & 干预措施
Active Group
Will receive Heme Arginate (IMP) at a dose of 3mg/kg over 30mins. Participants will receive infusions of the IMP at 2 time-points, the first prior to surgery (transplantation), and the second 20-28 hours later. At each infusion, the IMP will be followed by a 100ml infusion of 0.9% Sodium Chloride over 15mins.
干预措施: Heme Arginate 25 MG/ML (Drug)
Placebo Group
Will receive a 100ml infusion of 0.9% Sodium Chloride (placebo) over 30mins. Participants will receive infusions at 2 time-points, the first prior to surgery, and the second 20-28 hours later. At each infusion, the placebo will be followed by a further 100ml infusion of 0.9% Sodium Chloride over 15mins.
干预措施: 0.9% Sodium-chloride (Drug)
结局指标
主要结局
Delayed Graft Function
时间窗: 1 week post transplant
The incidence of delayed graft function, defined as failure of a spontaneous fall in creatinine of \>10% for each 3 consecutive day period in the first week following transplantation, with comparison between the two randomised groups.
次要结局
- Requirement for dialysis(1 week post transplant)
- Time to functioning graft(1 week)
- Length of hospital stay(3 months)
- Creatinine levels(3 months)
- Acute rejection(3 months)
- SF36 Quality of Life(Up to 3 months post transplant)
- Cost per QALY gained(Up to 3 months post transplant)