NCT07393594

Brief Summary

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).

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
28mo left

Started Mar 2026

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress8%
Mar 2026Oct 2028

First Submitted

Initial submission to the registry

January 30, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 6, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

March 31, 2026

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2028

Last Updated

February 24, 2026

Status Verified

February 1, 2026

Enrollment Period

2.1 years

First QC Date

January 30, 2026

Last Update Submit

February 20, 2026

Conditions

Kidney DiseasesKidney InjuryBK Virus InfectionCMVTTV Virus

Keywords

Biomarkers testingKidney transplant rejectionT-ID AssayTRAC Assay cell free DNABiopsydd-cfDNAT-ID

Outcome Measures

Primary Outcomes (1)

  • 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.

    * CMV disease will be defined according to standard clinical criteria, including CMV syndrome and/or tissue-invasive CMV disease, as determined by the treating clinician and documented in the medical record. * BK virus-associated nephropathy (BKVAN) will be defined as biopsy-proven BK virus nephropathy, characterized by histopathologic features consistent with BKVAN (including intranuclear viral inclusions and/or positive SV40 large T-antigen staining), in the setting of documented BK viral replication by standard-of-care testing (e.g., plasma or urine PCR).

    12 Months

Interventions

Blood tests, TRAC( cell free DNA) and T-IDDIAGNOSTIC_TEST

Blood collection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • 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.

You may not qualify if:

  • Recipient of a combined organ transplant involving a non-renal solid organ (e.g., kidney-liver, kidney-heart) and/or islet cell transplantation.
  • History of prior non-renal solid organ transplantation or islet cell transplantation.
  • Known pregnancy at the time of enrollment.
  • Known active viral infection at enrollment with any of the following:
  • Hepatitis B surface antigen (HBsAg)-positive
  • Hepatitis B virus (HBV) nucleic acid testing (NAT)-positive
  • Human immunodeficiency virus (HIV) infection or HIV NAT-positive
  • \*Known active BK virus-associated nephropathy (BKVAN) or CMV disease at the time of enrollment.
  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • 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

    BACKGROUND

  • 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.

    PMID: 29174434BACKGROUND

  • 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.

    PMID: 38972761BACKGROUND

  • 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.

    PMID: 34620649BACKGROUND

  • 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 T. Develop-ment and clinical validity of a novel blood-based molecular biomarker for subclinical acute rejection following kidney transplant. Am J Transplant. 2019;19(1):98-109. Epub 2018/07/10. doi: 10.1111/ajt.15011. PubMed PMID: 29985559; PMCID: PMC6387870

    BACKGROUND

  • 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.

    PMID: 24445740BACKGROUND

  • 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.

    PMID: 23480233BACKGROUND

  • 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.

    PMID: 32463180RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Kidney Diseases

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Central Study Contacts

Isioma Agboli, MD

CONTACT

510 767 8609isioma.agboli@tgi.eurofinsus.com

Bethany Barrick

CONTACT

619 643 1929bethany.barrick@tgi.eurofinsus.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2026

First Posted

February 6, 2026

Study Start

March 31, 2026

Primary Completion (Estimated)

April 30, 2028

Study Completion (Estimated)

October 30, 2028

Last Updated

February 24, 2026

Record last verified: 2026-02