Immunosuppression Optimization Using The Prospera Assay In Kidney Transplant Recipients (IMPAKT) (IMPAKT)
2026년 7월 17일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (추정된)
750
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Natera, Inc.
- 전화번호: 650-273-4468
- 이메일: impakt@natera.com
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
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- 고령자
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아니
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
간섭 없음: 컨트롤 암
|
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활성 비교기: 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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Tier 1: Compare the number of randomized participants who experienced death related to allograft, using a win ratio hierarchical endpoint
기간: From enrollment to 24 months post-transplant
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The rate of death, defined as related to the allograft, in the test and control arms will be calculated and compared.
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From enrollment to 24 months post-transplant
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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
기간: 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.
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From enrollment to 24 months post-transplant
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Tier 3: Compare the number of randomized participants who experienced eGFR decline >30% between 6 and 24 months, using a win ratio hierarchical endpoint.
기간: From enrollment to 24 months post-transplant
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The eGFR measurement will be calculated using the 2021 CKD-EPI formula without race.
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From enrollment to 24 months post-transplant
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Tier 4: Compare the number of randomized participants who experienced biopsy proven rejection requiring treatment with intravenous medications, using a win ratio hierarchical endpoint.
기간: From enrollment to 24 months post-transplant
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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.
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From enrollment to 24 months post-transplant
|
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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.
기간: From enrollment to 24 months post-transplant
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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.
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From enrollment to 24 months post-transplant
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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.
기간: From enrollment to 24 months post-transplant
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The rate of de novo DSA, in the test and control arms will be calculated and compared.
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From enrollment to 24 months post-transplant
|
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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.
기간: 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.
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From enrollment to 24 months post-transplant
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 7월 1일
기본 완료 (추정된)
2027년 12월 1일
연구 완료 (추정된)
2031년 7월 1일
연구 등록 날짜
최초 제출
2026년 6월 23일
QC 기준을 충족하는 최초 제출
2026년 7월 17일
처음 게시됨 (실제)
2026년 7월 22일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 22일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 17일
마지막으로 확인됨
2026년 7월 1일
추가 정보
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