Attenuating Ischemia Reperfusion Injury After Living Donor Renal Transplantation
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- reduction in ischemia reperfusion injury
研究概览
简要总结
Patients undergoing living donor renal transplant will be asked to participate to determine whether pre-operative dosing of immunosuppressive medication, and the donor organ receiving an additional dose of antibody induction therapy helps to alleviate potential damage to the transplanted organ post-transplant. A number of lab tests will be done post-transplant to determine how well the kidney is functioning.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be able to provide written informed consent.
- •All recipients of a kidney from a living donor only, either a de novo transplant, or re-transplant
- •All patients evaluated and listed with the United Network for Organ Sharing (UNOS) who are eligible to receive a kidney transplant under GUH's standard protocol.
- •Patients between 18-80 years of age
排除标准
- •Recipients of multi-organ transplant
- •Patients with known allergies of hypersensitivities to any of the drugs used in this protocol
- •Recipients of kidneys from a deceased donor
- •Recipients who are co-infected with Hepatitis B, Hepatitis C or HIV
- •Women who are pregnant
- •Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle or sexual orientation precludes intercourse with a male partner unless they agree to avoid pregnancy throughout the duration of the trial and for 3 months following the trial.
研究组 & 干预措施
pre-transplant immunosuppression
subjects in this arm will receive Myfortic 720mg twice daily for 7 days prior to transplantation. Intra-operatively, the donor kidney will receive an infusion of Thymoglobulin, prior to the transplantation.
干预措施: Myfortic (mycophenolic acid) (Drug)
pre-transplant immunosuppression
subjects in this arm will receive Myfortic 720mg twice daily for 7 days prior to transplantation. Intra-operatively, the donor kidney will receive an infusion of Thymoglobulin, prior to the transplantation.
干预措施: Thymoglobulin (anti-thymocyte globulin) (Drug)
pre-transplant induction
subjects in this arm will not receive any pre-transplant immunosuppression. However, the donor kidney will receive an infusion of Thymoglobulin prior to transplantation.
干预措施: Myfortic (mycophenolic acid) (Drug)
pre-transplant induction
subjects in this arm will not receive any pre-transplant immunosuppression. However, the donor kidney will receive an infusion of Thymoglobulin prior to transplantation.
干预措施: Thymoglobulin (anti-thymocyte globulin) (Drug)
standard of care
subjects in this arm will not receive any pre-transplant immunosuppression, and the donor kidney will not receive an additional dose of Thymoglobulin prior to transplantation. This is the standard of care protocol for Georgetown University Hospital
干预措施: Myfortic (mycophenolic acid) (Drug)
standard of care
subjects in this arm will not receive any pre-transplant immunosuppression, and the donor kidney will not receive an additional dose of Thymoglobulin prior to transplantation. This is the standard of care protocol for Georgetown University Hospital
干预措施: Thymoglobulin (anti-thymocyte globulin) (Drug)
结局指标
主要结局
reduction in ischemia reperfusion injury
时间窗: one year
Monitor immediate graft functioning, mitochodrial membrane potential, serum creatinine, and cylex immunomonitoring to determine if pre-transplant immunosuppression, and an additional intra-operative dose of induction agent helps to reduce ischemic reperfusion injury.
次要结局
- secondary outcomes(one year)
研究者
Keith Melancon,MD
Director of kidney and pancreas transplantation
Georgetown University