Attenuating Ischemia Reperfusion Injury After Living Donor Renal Transplantation
2014年6月6日 更新者：Keith Melancon,MD、Georgetown University
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.
研究概览
地位
撤销
研究类型
介入性
阶段
- 第四阶段
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 80年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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.
|
720mg twice a day for 7 days prior to transplantation
720mg twice a day after transplant
up to 25 mg will be infused into the renal artery of a donor kidney prior to transplantation into the recipient.
standard of care for Georgetown University Hospital: 1.5 mg/kg/day infused over 6 hours.
|
|
实验性的：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.
|
720mg twice a day for 7 days prior to transplantation
720mg twice a day after transplant
up to 25 mg will be infused into the renal artery of a donor kidney prior to transplantation into the recipient.
standard of care for Georgetown University Hospital: 1.5 mg/kg/day infused over 6 hours.
|
|
有源比较器：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
|
720mg twice a day for 7 days prior to transplantation
720mg twice a day after transplant
up to 25 mg will be infused into the renal artery of a donor kidney prior to transplantation into the recipient.
standard of care for Georgetown University Hospital: 1.5 mg/kg/day infused over 6 hours.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
reduction in ischemia reperfusion injury
大体时间：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.
|
one year
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
secondary outcomes
大体时间：one year
|
incidence of acute rejection, graft survival, patient survival, change in cylex values
|
one year
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员：Joseph K Melancon, MD、Georgetown University Hospital
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2010年6月1日
初级完成 (实际的)
2012年6月1日
研究完成 (实际的)
2012年6月1日
研究注册日期
首次提交
2010年6月21日
首先提交符合 QC 标准的
2010年6月23日
首次发布 (估计)
2010年6月24日
研究记录更新
最后更新发布 (估计)
2014年6月9日
上次提交的符合 QC 标准的更新
2014年6月6日
最后验证
2014年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Myfortic (mycophenolic acid)的临床试验
-
University College, LondonImperial College London; Cancer Research UK; National Cancer Imaging Translational Accelerator招聘中
-
Gladwin, Mark, MDNational Heart, Lung, and Blood Institute (NHLBI); Complexa, Inc.终止
-
University of California, San Francisco撤销