Observationsstudie, der evaluerer seriel T-ID-overvågning -ID-ENTITY (ID-ENTITY)
1. oktober 2026 opdateret af: Transplant Genomics, Inc.
Et prospektivt, multicenter, observationsstudie, der evaluerer seriel T-ID-overvågning til forebyggelse af CMV-sygdom og BK-virus-associeret nefropati efter nyretransplantation
To evaluate the association between time-updated CMV and BK viral loads measured monthly by T-ID and the risk of CMV disease and/or biopsy-proven BK virus-associated nephropathy (BKVAN) during the first 12 months following kidney transplantation, accounting for the net immune environment (TTV viral load) and allograft injury (donor-derived cell-free DNA, dd-cfDNA).
Studieoversigt
Status
Tilmelding efter invitation
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
- To characterize time-updated viral detection patterns (e.g., transient vs sustained CMV or BK signals) identified by T-ID prior to development of CMV disease or BKVAN.
- To evaluate the clinical utility of T-ID monitoring, defined by the frequency and type of clinical management actions taken following test results.
- To estimate the diagnostic performance of T-ID for clinically meaningful viral infection compared with standard-of-care (PCR) testing and clinical adjudication.
- To quantify lead time between T-ID detection of viral cfDNA and standard-of-care confirmation or initiation of therapy.
- To assess the safety of biomarker-informed management, including both rejection following infection-directed management and infection following rejection-directed management.
Undersøgelsestype
Observationel
Tilmelding (Anslået)
1000
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Arizona
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Phoenix, Arizona, Forenede Stater, 85054
- Mayo Clinic Arizona
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California
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Los Angeles, California, Forenede Stater, 90095
- UCLA
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Los Angeles, California, Forenede Stater, 90033
- Keck Hospital of USC
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Kansas
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Kansas City, Kansas, Forenede Stater, 66160
- University of Kansas Medical Center
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Michigan
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Detroit, Michigan, Forenede Stater, 48202
- Henry Ford Health
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New Hampshire
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Lebanon, New Hampshire, Forenede Stater, 03756
- Dartmouth
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New Jersey
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Livingston, New Jersey, Forenede Stater, 07039
- Cooperman Barnabas Medical Center
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New York
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Buffalo, New York, Forenede Stater, 14215
- Erie County Medical Center
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North Carolina
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Greenville, North Carolina, Forenede Stater, 27834
- Eastern Carolina University, Brody School of Medicine
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Winston-Salem, North Carolina, Forenede Stater, 27157
- Atrium Health Wake Forest Baptist
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South Carolina
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Charleston, South Carolina, Forenede Stater, 29425
- Medical University of South Carolina
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Texas
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Dallas, Texas, Forenede Stater, 75230
- Dallas Renal Group
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Utah
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Murray, Utah, Forenede Stater, 84107
- Intermountain Health
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Virginia
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Falls Church, Virginia, Forenede Stater, 22042
- Inova Fairfax Hospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
All subjects who meet eligibility criteria will be enrolled. As this is a non-interventional study, the protocol does not mandate any specific diagnostic, therapeutic, or management interventions. Clinical management decisions, including adjustments to immunosuppression, antiviral therapy, diagnostic testing, and biopsy decisions, remain entirely at the discretion of the treating clinicians.
Beskrivelse
Inclusion Criteria:
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Participants must meet all the following criteria:
- Written informed consent and HIPAA authorization obtained prior to any study-related data collection.
- Age ≥18 years at the time of enrollment.
- Recipient of a kidney transplant, including:
- Primary or repeat kidney transplantation
- Living-donor or deceased-donor transplantation
- At 1 month post-kidney transplant at the time of enrollment.
- Receiving maintenance immunosuppressive therapy per institutional standard of care.
- Selected by the treating provider to undergo TRAC testing as part of usual post-transplant clinical monitoring.
Exclusion Criteria:
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Recipient of a combined organ transplant involving a non-renal solid organ (e.g., kidney-liver, kidney-heart) and/or islet cell transplantation.
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History of prior non-renal solid organ transplantation or islet cell transplantation.
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Known pregnancy at the time of enrollment.
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Known active viral infection at enrollment with any of the following:
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Hepatitis B surface antigen (HBsAg)-positive
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Hepatitis B virus (HBV) nucleic acid testing (NAT)-positive
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Human immunodeficiency virus (HIV) infection or HIV NAT-positive
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*Known active BK virus-associated nephropathy (BKVAN) or CMV disease at the time of enrollment.
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Medical, psychiatric, or social condition that, in the opinion of the Investigator, would interfere with the participant's ability to provide informed consent or comply with study procedures.
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Concurrent participation in another investigational biomarker study designed to evaluate clinical utility of post-transplant molecular diagnostics.
- Participants with asymptomatic or low-level viral replication detected during routine clinical monitoring are eligible, provided there is no evidence of established CMV disease or BK virus-associated nephropathy at enrollment.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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The primary endpoint of the study is the time to first occurrence of either cytomegalovirus (CMV) disease or biopsy-proven BK virus-associated nephropathy (BKVAN) during the first 12 months post-kidney transplantation.
Tidsramme: 12 Months
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12 Months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Lo DJ, Kaplan B, Kirk AD. Biomarkers for kidney transplant rejection. Nat Rev Nephrol. 2014 Apr;10(4):215-25. doi: 10.1038/nrneph.2013.281. Epub 2014 Jan 21.
- Friedewald JJ, Kurian SM, Heilman RL, Whisenant TC, Poggio ED, Marsh C, Baliga P, Odim J, Brown MM, Ikle DN, Armstrong BD, Charette JI, Brietigam SS, Sustento-Reodica N, Zhao L, Kandpal M, Salomon DR, Abecassis MM; Clinical Trials in Organ Transplantation 08 (CTOT-08). Development and clinical validity of a novel blood-based molecular biomarker for subclinical acute rejection following kidney transplant. Am J Transplant. 2019 Jan;19(1):98-109. doi: 10.1111/ajt.15011. Epub 2018 Aug 31.
- Park S, Guo K, Heilman RL, Poggio ED, Taber DJ, Marsh CL, Kurian SM, Kleiboeker S, Weems J, Holman J, Zhao L, Sinha R, Brietigam S, Rebello C, Abecassis MM, Friedewald JJ. Combining Blood Gene Expression and Cellfree DNA to Diagnose Subclinical Rejection in Kidney Transplant Recipients. Clin J Am Soc Nephrol. 2021 Oct;16(10):1539-1551. doi: 10.2215/CJN.05530421.
- Clinical Utility of Peripheral Blood Gene Expression Profiling of Kidney Transplant Recipients to Assess the Need for Surveillance Biopsies in Subjects with Stable Renal Function January 2017 Journal of Transplantation Technologies & Research 07(03) DOI: 10.4172/2161-0991.1000177 Martin Roy First Thomas C Whisenant John Friedewald Show all 10 authors Michael M Abecassis Citations 6 Reads 239
- Bouamar R, Shuker N, Hesselink DA, Weimar W, Ekberg H, Kaplan B, Bernasconi C, van Gelder T. Tacrolimus predose concentrations do not predict the risk of acute rejection after renal transplantation: a pooled analysis from three randomized-controlled clinical trials(dagger). Am J Transplant. 2013 May;13(5):1253-61. doi: 10.1111/ajt.12191. Epub 2013 Mar 8.
- Arms MA, Fleming J, Sangani DB, Nadig SN, McGillicuddy JW, Taber DJ. Incidence and impact of adverse drug events contributing to hospital readmissions in kidney transplant recipients. Surgery. 2018 Feb;163(2):430-435. doi: 10.1016/j.surg.2017.09.027. Epub 2017 Nov 22.
- Sinha R, Zhu Z, Park S, Rebello C, Kinsella B, Friedewald J, Kleiboeker S. Combined Metagenomic Viral Detection and Donor-Derived Cell-Free DNA Quantification in Plasma From Kidney Transplant Recipients. Transplant Proc. 2024 Jul-Aug;56(6):1522-1530. doi: 10.1016/j.transproceed.2024.06.003. Epub 2024 Jul 6.
- Loupy A, Haas M, Roufosse C, Naesens M, Adam B, Afrouzian M, Akalin E, Alachkar N, Bagnasco S, Becker JU, Cornell LD, Clahsen-van Groningen MC, Demetris AJ, Dragun D, Duong van Huyen JP, Farris AB, Fogo AB, Gibson IW, Glotz D, Gueguen J, Kikic Z, Kozakowski N, Kraus E, Lefaucheur C, Liapis H, Mannon RB, Montgomery RA, Nankivell BJ, Nickeleit V, Nickerson P, Rabant M, Racusen L, Randhawa P, Robin B, Rosales IA, Sapir-Pichhadze R, Schinstock CA, Seron D, Singh HK, Smith RN, Stegall MD, Zeevi A, Solez K, Colvin RB, Mengel M. The Banff 2019 Kidney Meeting Report (I): Updates on and clarification of criteria for T cell- and antibody-mediated rejection. Am J Transplant. 2020 Sep;20(9):2318-2331. doi: 10.1111/ajt.15898. Epub 2020 May 28.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
19. maj 2026
Primær færdiggørelse (Anslået)
30. april 2028
Studieafslutning (Anslået)
30. oktober 2028
Datoer for studieregistrering
Først indsendt
30. januar 2026
Først indsendt, der opfyldte QC-kriterier
30. januar 2026
Først opslået (Faktiske)
6. februar 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
6. oktober 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. oktober 2026
Sidst verificeret
1. oktober 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- TGRP32 ID-ENTITY
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
UBESLUTET
IPD-planbeskrivelse
All data collected will be analyzed and submitted to Journals publications.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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