Observasjonsstudie som evaluerer seriell T-ID-overvåking -ID-IDENTITET (ID-ENTITY)
1. oktober 2026 oppdatert av: Transplant Genomics, Inc.
En prospektiv, multikenter, observasjonsstudie som evaluerer seriell T-ID-overvåkning for forebygging av CMV-sykdom og BK-virus-assosiert nefropati etter nyretransplantasjon
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).
Studieoversikt
Status
Påmelding etter invitasjon
Intervensjon / Behandling
Detaljert 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.
Studietype
Observasjonsmessig
Registrering (Antatt)
1000
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Arizona
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Phoenix, Arizona, Forente stater, 85054
- Mayo Clinic Arizona
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California
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Los Angeles, California, Forente stater, 90095
- UCLA
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Los Angeles, California, Forente stater, 90033
- Keck Hospital of USC
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Kansas
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Kansas City, Kansas, Forente stater, 66160
- University of Kansas Medical Center
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Michigan
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Detroit, Michigan, Forente stater, 48202
- Henry Ford Health
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New Hampshire
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Lebanon, New Hampshire, Forente stater, 03756
- Dartmouth
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New Jersey
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Livingston, New Jersey, Forente stater, 07039
- Cooperman Barnabas Medical Center
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New York
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Buffalo, New York, Forente stater, 14215
- Erie County Medical Center
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North Carolina
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Greenville, North Carolina, Forente stater, 27834
- Eastern Carolina University, Brody School of Medicine
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Winston-Salem, North Carolina, Forente stater, 27157
- Atrium Health Wake Forest Baptist
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South Carolina
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Charleston, South Carolina, Forente stater, 29425
- Medical University of South Carolina
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Texas
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Dallas, Texas, Forente stater, 75230
- Dallas Renal Group
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Utah
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Murray, Utah, Forente stater, 84107
- Intermountain Health
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Virginia
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Falls Church, Virginia, Forente stater, 22042
- Inova Fairfax Hospital
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
19. mai 2026
Primær fullføring (Antatt)
30. april 2028
Studiet fullført (Antatt)
30. oktober 2028
Datoer for studieregistrering
Først innsendt
30. januar 2026
Først innsendt som oppfylte QC-kriteriene
30. januar 2026
Først lagt ut (Faktiske)
6. februar 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
6. oktober 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
1. oktober 2026
Sist bekreftet
1. oktober 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Urogenitale sykdommer
- Mannlige urogenitale sykdommer
- Urologiske sykdommer
- Kvinnelige urogenitale sykdommer
- Kvinnelige urogenitale sykdommer og graviditetskomplikasjoner
- Nyresykdommer
- Undersøkelsesteknikker
- Kliniske laboratorieteknikker
- Diagnostiske teknikker og prosedyrer
- Diagnose
- Hematologiske tester
Andre studie-ID-numre
- TGRP32 ID-ENTITY
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
UBESLUTTE
IPD-planbeskrivelse
All data collected will be analyzed and submitted to Journals publications.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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