Belatacept to Prevent Organ Rejection in Kidney Transplant Patients (BESTT)
The Safety and Efficacy of Belatacept, Antithymocyte Globulin, and Sirolimus in Recipients of Non-HLA-identical Living-donor Renal Transplants (ITN023ST)
研究概览
详细说明
Drugs that suppress the immune system have contributed to increased success of transplantation; however, to prevent organ rejection, transplant recipients need to take immunosuppressive drugs for the rest of their lives. These drugs make patients more susceptible to infection and certain kinds of cancer. Belatacept is an experimental medication that specifically targets immune reactions against transplanted organs and has been shown to be effective in preventing kidney transplant rejection in previous clinical trials. Both thymoglobulin, an antibody, and sirolimus, an anti-rejection drug, prevent rejection by lowering the response of the immune system to the transplanted organ. This study will evaluate whether belatacept, along with thymoglobulin and sirolimus, is safe in kidney transplant patients. The study will also evaluate this regimen's potential to allow tapering and eventual discontinuation of all immunosuppressive drugs.
This study will last up to 4 years. At the time of transplant, participants will begin an immunosuppressive treatment regimen consisting of thymoglobulin, sirolimus, and belatacept. Participants will receive infusions of thymoglobulin on days 1 through 4, and a combination of oral sirolimus (daily) and belatacept infusions at day 5, then weeks 2, 4, 8, and monthly for at least 2 years. Dose reduction of belatacept will occur at 12 weeks post-transplant. At Year 2, eligible participants may choose to begin drug withdrawal or continue study therapy through the end of the study. Study visits will occur weekly for the first two months, then monthly. These visits will include belatacept treatment, general medical assessments, blood and urine collection, and other assessments to determine overall health of the recipient's immune system and kidney transplant and to better understand the way the immune system works in the acceptance or rejection of organ transplants.
*** IMPORTANT NOTICE: *** The National Institute of Allergy and Infectious Diseases and the Immune Tolerance Network do not recommend the discontinuation of immunosuppressive therapy for recipients of cell, organ, or tissue transplants outside of physician-directed, controlled clinical studies. Discontinuation of prescribed immunosuppressive therapy can result in serious health consequences and should only be performed in certain rare circumstances, upon the recommendation and with the guidance of your health care provider.
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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California
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San Francisco、California、美国、94143
- University of California, San Francisco
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Georgia
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Atlanta、Georgia、美国、30322
- Emory University
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Receiving first renal (e.g., kidney) transplant
- Transplant is from a non-HLA-identical living donor
- Willing to use acceptable forms of contraception
Exclusion Criteria:
- Positive for anti-human globulin (AHG) or T-cell cross-match with the donor
- Receiving multiple-organ transplant
- History of cancer within the 5 years prior to study entry. Patients who have certain nonmelanoma skin cancers are not excluded
- Human immunodeficiency virus (HIV) infected
- Hepatitis B (HBV) or C (HCV) virus infected
- Other active infections
- Active tuberculosis (TB) infection within the 3 years prior to study entry
- Pregnancy or breastfeeding
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Belatacept
Immunosuppressive protocol consisting of belatacept, glucocorticoids, antithymocyte globulin (ATG), and sirolimus.
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10 mg/kg given intravenously (IV) on transplant (day 1), day 5, and at weeks 2, 4, 8 and 12, then 5 mg/kg IV every 4 weeks
其他名称:
4 mg/day (oral tablet) at transplant (day 1), then dose adjusted to maintain serum trough level of 8-12 ng/mL for at least 1 year
其他名称:
1.5 mg/kg given IV daily on days 1 through 4. Subjects are premedicated with glucocorticoids, acetaminophen 650 mg by mouth, and diphenhydramine 25- 50 mg by mouth prior to each dose.
其他名称:
500 mg given IV at transplant (day 1), then given 250 mg IV on day 2 and given 0.5 mg/kg IV or prednisone 0.5 mg/kg given by mouth on days 3 and 4
其他名称:
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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 |
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Acute Rejection at 6-Months
大体时间:6 months post-transplant
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Cumulative incidence of acute rejection[1] at 6 months post-transplant based on local pathology biopsy reads
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6 months post-transplant
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Participant Survival at 12 Months Post-Transplant
大体时间:12 months post-transplant
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12 months post-transplant
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Acute Rejection at 12-Months
大体时间:12 months post-transplant
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Incidence of acute rejection[1] at 12 months post-transplant
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12 months post-transplant
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Tolerance Induction
大体时间:48 months
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Time from transplantation to initiation of sirolimus withdrawal.
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48 months
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Renal Function as Measured by Glomerular Filtration Rate (GFR) at 24 Weeks
大体时间:24 weeks post-transplant
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GFR utilizing clearance of iothalamate. GFR is an index of level of kidney function. A higher value means better kidney function. |
24 weeks post-transplant
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Graft Survival at 12 Months Post-transplant
大体时间:12 months post-transplant
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12 months post-transplant
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Time From Transplant to Acute Rejection
大体时间:Transplantation until rejection occurs (participants followed up to four years post-transplantation)
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Time (days) from transplant to occurrence of acute rejection[1]
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Transplantation until rejection occurs (participants followed up to four years post-transplantation)
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Proportion of Participants Requiring Antilymphocyte Therapy for Acute Rejection
大体时间:Participants followed from transplantation until completion of study (up to four years post-transplantation)
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Proportion of participants who experienced acute rejection[1] requiring antilymphocyte therapy
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Participants followed from transplantation until completion of study (up to four years post-transplantation)
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Proportion of Participants With Post-transplant Infections
大体时间:Participants followed from transplantation until completion of study (up to four years post-transplantation)
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Proportion of participants who experienced infections post-transplant.
Participants were checked for any type of opportunistic infection at all study visits post-transplantation (up to 4 years post-transplantation)
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Participants followed from transplantation until completion of study (up to four years post-transplantation)
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Proportion of Participants With Wound Complications
大体时间:Start of study to end of study
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Start of study to end of study
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Proportion of Participants With Malignancies
大体时间:Participants followed from transplantation until completion of study (up to four years post-transplantation)
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Participants followed from transplantation until completion of study (up to four years post-transplantation)
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Proportion of Participants With a Sirolimus Associated Adverse Event
大体时间:Participants followed from transplantation until completion of study (up to four years post-transplantation)
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Participants followed from transplantation until completion of study (up to four years post-transplantation)
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Proportion of Participants With Chronic Allograft Nephropathy
大体时间:Participants followed from transplantation until completion of study (up to four years post-transplantation)
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Participants followed from transplantation until completion of study (up to four years post-transplantation)
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Proportion of Participants With Delayed Graft Function
大体时间:Participants followed from transplantation until completion of study (up to four years post-transplantation)
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Participants followed from transplantation until completion of study (up to four years post-transplantation)
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Proportion of Participants With Post-transplant Diabetes Mellitus
大体时间:Participants followed from transplantation until completion of study (up to four years post-transplantation)
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Participants followed from transplantation until completion of study (up to four years post-transplantation)
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合作者和调查者
调查人员
- 首席研究员:Flavio Vincenti, MD、University of California, San Francisco
- 首席研究员:Christian Larsen, MD、Emory University
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- DAIT ITN023ST
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
研究数据/文件
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个人参与者数据集
信息标识符:SDY674信息评论:ImmPort study identifier is SDY674
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研究协议
信息标识符:SDY674信息评论:ImmPort study identifier is SDY674. The study protocol is available in the Design tab section.
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Study summary, -design, -synopsis,- medications, -demographics, -lab tests, -files
信息标识符:SDY674信息评论:ImmPort study identifier is SDY674
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个人参与者数据集
信息标识符:ITN023ST信息评论:TrialShare is a clinical trials research portal developed by the Immune Tolerance Network (ITN) that makes data from the consortium's clinical trials publicly available.
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Protocol synopsis, -data and reports, -specimens availability
信息标识符:ITN023ST信息评论:TrialShare is a clinical trials research portal developed by the Immune Tolerance Network (ITN) that makes data from the consortium's clinical trials publicly available.
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.
Belatacept的临床试验
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Bristol-Myers Squibb完全的肾移植美国, 阿根廷, 德国, 意大利, 智利, 西班牙, 巴西, 瑞典, 比利时, 法国, 匈牙利, 澳大利亚, 南非, 奥地利, 加拿大, 英国, 波兰, 捷克语, 挪威
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Assistance Publique - Hôpitaux de ParisBristol-Myers Squibb完全的
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University of California, San FranciscoJuvenile Diabetes Research Foundation完全的
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Nantes University Hospital尚未招聘