Renal Ex Vivo SYN002 Perfusion to Eliminate CMV Transmission: A Safety Trial in Kidney Transplant Recipients
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Graft function
研究概览
简要总结
Donor organs often carry latent Cytomegalovirus (CMV) infection that may be transmitted to the recipient. The goal of this clinical trial is to determine the safety of SYN002 treatment during Ex-Vivo Organ Perfusion (EVOP) in clinical kidney transplantation. Donor kidneys will be treated on the EVOP system with SYN002 in order to decrease the burden of latent CMV in the organ and mitigate the transmission of cytomegalovirus (CMV).
详细描述
Cytomegalovirus (CMV) is the most common viral infection in transplant recipients and has major impacts on patient outcomes. It can cause fever, pneumonia, gastrointestinal disease, and lead to rejection of the kidney. To prevent this, transplant recipients receive prolonged antiviral drugs. This leads to significant drug toxicity and cost, and is often not successful. The risk of CMV is much higher if the donor organ carries latent CMV inside it (approximately 50-70% of donor organs). A much better and safer strategy would therefore be to try to eliminate the latent virus from the donor organ prior to transplantation. Ex Vivo Organ Perfusion (EVOP) is a common method of donor organ preservation and treatment which allows donor organs to be treated for several hours under close to physiological conditions.
The investigators propose a study in which kidneys will be treated prior to transplantation on the EVOP platform in order to decrease latent CMV. SYN002 is a novel compound that binds to cells that are latently infected with CMV and is internalized and kills those specific cells. This pilot study will involve 12 kidney transplant patients, who are receiving a kidney known to have latent CMV. The kidney will be treated with SYN002 on the EVOP system prior to transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Open Label
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
- •Recipient Inclusion Criteria:
- •Age ≥18 years
- •Listed for kidney transplantation
- •Either CMV seronegative or seropositive
- •Willing to provide written informed consent to take part in the trial
- •Willing and able to return for follow-up visits as scheduled in the protocol
- •Not participating in other interventional trials
排除标准
- •Listed for combined organ transplant (e.g. kidney-pancreas or kidney-liver)
- •Re-transplantation
- •HIV positive
- •Highly sensitized recipient with a PRA >=95
- •Planned use of belatacept or alemtuzumab immunosuppression (both non-approved drugs in Canada)
- •Unable or unwilling to comply with study procedures
- •Donor Inclusion Criteria:
- •Deceased donor
- •CMV seropositive (D+)
- •Donor kidney meets criteria for transplantation
- •Single renal artery (required anatomy to perform EVOP)
- •Donor Exclusion Criteria:
- •CMV seronegative
- •Donor kidney not suitable for transplantation
结局指标
主要结局
Graft function
时间窗: 4 weeks post-transplant
Proportion of patients with a functioning graft at 4 weeks post-transplant defined as no longer needing dialysis at 4 weeks
次要结局
- CMV DNAemia 6 months(6 months post-transplant)
- CMV disease(6 months post-transplant)
- Delayed graft function(4 weeks post-transplant)
- CMV DNAemia 3 months(3 months post-transplant)
- Length of hospital stay(6 months post-transplant)
- Graft survival 3 months(3 months post-transplant)
- Graft survival 6 months(6 months)