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NCT Number: NCT07718633

Immunosuppression Optimization Using The Prospera Assay In Kidney Transplant Recipients (IMPAKT)

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.

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Key information

Conditions

Kidney Transplant Immunosuppresion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Prospera Immunosuppression Optimization

Diagnostic Test

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.

Primary outcomes

  1. Tier 1: Compare the number of randomized participants who experienced death related to allograft, using a win ratio hierarchical endpoint

    Time frame: 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.

  2. 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

    Time frame: 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.

  3. Tier 3: Compare the number of randomized participants who experienced eGFR decline >30% between 6 and 24 months, using a win ratio hierarchical endpoint.

    Time frame: From enrollment to 24 months post-transplant

    The eGFR measurement will be calculated using the 2021 CKD-EPI formula without race.

  4. Tier 4: Compare the number of randomized participants who experienced biopsy proven rejection requiring treatment with intravenous medications, using a win ratio hierarchical endpoint.

    Time frame: 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.

  5. 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.

    Time frame: 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.

  6. 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.

    Time frame: From enrollment to 24 months post-transplant

    The rate of de novo DSA, in the test and control arms will be calculated and compared.

  7. 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.

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Natera, Inc.

CONTACT

[email protected]

650-273-4468

Sponsors and collaborators

Lead sponsor

Natera, Inc.

Industry

Registry information

Official study title

Immunosuppressant optiMization Using the Prospera Assay in Kidney Transplant (IMPAKT) Randomized Controlled Trial

Acronym: IMPAKT

Important dates

Study start
2026
Primary completion
2027
Study completion
2031
First posted
Jul 22, 2026
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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