Immunosuppression Optimization Using The Prospera Assay In Kidney Transplant Recipients (IMPAKT) (IMPAKT)
2026年7月17日 更新者：Natera, Inc.
Immunosuppressant optiMization Using the Prospera Assay in Kidney Transplant (IMPAKT) Randomized Controlled Trial
IMPAKT is a research study that looks at whether a blood test called Prospera™ can help doctors better adjust anti-rejection medications, compared to the usual way doctors manage these medications without using this test.
研究概览
详细说明
The IMPAKT study is a multi-center randomized controlled trial (RCT) in which stable low-risk kidney transplant (Tx) recipients receiving maintenance immunosuppression with tacrolimus, MPA dosage with or without corticosteroids will be randomized to the Immunosuppression optimization (Test) arm or the Standard of Care (SoC) Immunosuppression (Control) arm.
Participants will be enrolled at three months posttransplant and monitored with routine standard of care treatment and monthly Prospera blood draws from enrollment to 6 months posttransplant. All subjects will follow their center's SoC immunosuppressive therapy (IST) from enrollment to 6 months post-transplant. Subjects will be randomized at 6 months post-transplant to either the Test arm versus the Control arm.
The test arm will include participants who are managed with routine clinical care, along with a standardized dd-cfDNA protocol, to guide optimization of immunosuppression dosages. The control arm will include subjects who are managed with routine clinical care and receiving the standard of care (SoC) immunosuppression. This RCT will compare a hierarchical composite end point between the test and the control arm at 24 months post-transplant.
研究类型
介入性
注册 (估计的)
750
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Natera, Inc.
- 电话号码：650-273-4468
- 邮箱：impakt@natera.com
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
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Subjects received a kidney transplant in the prior 3 months.
- Subjects receiving maintenance therapy consisting of tacrolimus, mycophenolate sodium or mycophenolate mofetil, and optionally corticosteroids, at the time of enrollment.
- Subjects received induction therapy comprising IL2 receptor antagonist or thymoglobulin, or received no induction therapy.
- 18 years of age or older at time of signing informed consent.
- Able to read, understand and provide written informed consent, and willing and able to comply with the study requirements. If the subject is unable to sign the informed consent, a legally authorized representative (LAR) can consent on behalf of the subject.
- Subjects are at the site standard-of-care MPA dosage
Exclusion Criteria:
- Concurrent multiple solid organ or tissue transplants.
- History of a previous organ transplant (aside from present kidney transplant), or cellular transplant.
- DSA Positive according to local protocol, including either pre-transplant DSA positivity and de novo DSA positivity.
- Any prior dd-cfDNA results ≥1.0% or ≥78cp/mL after 28 days post-transplant.
- ABO Incompatible donor.
- A serious medical condition that may adversely affect ability to participate in the study (e.g, current diagnosis of cancer).
- Pregnancy.
- Received any induction therapy other than IL2 receptor antagonist or thymoglobulin.
- Receiving any maintenance immunosuppression other than tacrolimus, mycophenolate sodium or mycophenolate mofetil, and prednisone.
- Currently undergoing regular dialysis.
- Considered high-risk at the time of enrollment, as per the treating physician.
- Planned or ongoing use of other commercially available or investigational dd-cfDNA or blood-based gene expression profile assays for rejection surveillance, through randomization.
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 |
|---|---|
|
无干预：控制臂
|
|
|
有源比较器：Test Arm
|
The test arm will include participants who are managed with routine clinical care, along with a standardized dd-cfDNA protocol, to guide optimization of immunosuppression dosages.
|
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 |
|---|---|---|
|
Tier 1: Compare the number of randomized participants who experienced death related to allograft, using a win ratio hierarchical endpoint
大体时间：From enrollment to 24 months post-transplant
|
The rate of death, defined as related to the allograft, in the test and control arms will be calculated and compared.
|
From enrollment to 24 months post-transplant
|
|
Tier 2: Compare the number of randomized participants who experienced death censored graft loss (retransplant or return to dialysis), using a win ratio hierarchical endpoint
大体时间：From enrollment to 24 months post-transplant
|
The rate of graft loss, defined as return to dialysis and/or retransplant, in the test and control arms will be calculated and compared.
|
From enrollment to 24 months post-transplant
|
|
Tier 3: Compare the number of randomized participants who experienced eGFR decline >30% between 6 and 24 months, using a win ratio hierarchical endpoint.
大体时间：From enrollment to 24 months post-transplant
|
The eGFR measurement will be calculated using the 2021 CKD-EPI formula without race.
|
From enrollment to 24 months post-transplant
|
|
Tier 4: Compare the number of randomized participants who experienced biopsy proven rejection requiring treatment with intravenous medications, using a win ratio hierarchical endpoint.
大体时间：From enrollment to 24 months post-transplant
|
The rate of biopsy proven rejection by histology and the rate of treated rejection in the two arms between months 6 and 24 will be measured and compared.
|
From enrollment to 24 months post-transplant
|
|
Tier 5: Compare the number of randomized participants who experienced transplant-related hospitalization ≥2 nights not related to biopsy proven rejection, using a win ratio hierarchical endpoint.
大体时间：From enrollment to 24 months post-transplant
|
The average number of nights spent at an inpatient facility for graft-related issues, but not including biopsy proven rejection, by subjects in the test and control arms will be measured and compared.
|
From enrollment to 24 months post-transplant
|
|
Tier 6: Compare the number of randomized participants who developed de novo DSA after 6 months, and by 24 months, using a win ratio hierarchical endpoint.
大体时间：From enrollment to 24 months post-transplant
|
The rate of de novo DSA, in the test and control arms will be calculated and compared.
|
From enrollment to 24 months post-transplant
|
|
Tier 7: Compare the number of randomized participants who experienced adverse outcome (AO), defined as GI Toxicity, Leukopenia, and/or Infection, using a win ratio hierarchical endpoint.
大体时间：From enrollment to 24 months post-transplant
|
The Adverse Outcome (AO) rate at 24 months post-Tx will be compared between the test arm and the control arm, with the list of events qualifying as AO comprising: GI toxicity, leukopenia, and infection.
|
From enrollment to 24 months post-transplant
|
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。
赞助
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 (估计的)
2026年7月1日
初级完成 (估计的)
2027年12月1日
研究完成 (估计的)
2031年7月1日
研究注册日期
首次提交
2026年6月23日
首先提交符合 QC 标准的
2026年7月17日
首次发布 (实际的)
2026年7月22日
研究记录更新
最后更新发布 (实际的)
2026年7月22日
上次提交的符合 QC 标准的更新
2026年7月17日
最后验证
2026年7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.