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

17 juli 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

750

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Geen tussenkomst: Bedieningsarm
Actieve vergelijker: Test Arm
Diagnostische toets: Prospera Immunosuppression Optimization
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Natera, Inc.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juli 2026

Primaire voltooiing (Geschat)

1 december 2027

Studie voltooiing (Geschat)

1 juli 2031

Studieregistratiedata

Eerst ingediend

23 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

17 juli 2026

Eerst geplaatst (Werkelijk)

22 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

22 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

17 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • 25-098-OH

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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