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Kidney DiseasesID-ENTITYNCT07393594

ID-ENTITY Trial- Evaluating Serial T-ID Monitoring

An observational study of Kidney Diseases and Kidney Injury, run by Transplant Genomics, Inc. at 14 sites in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Kidney Diseases, Kidney Injury, BK Virus Infection
What is being tested?
Blood tests, TRAC( cell free DNA) and T-ID
How many people
1,000 participants
Where
14 sitesUnited States
Study dates
19 May 2026to 30 Oct 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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
Show all 9Show fewer
  • 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.

Who cannot join

  • 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
Show all 11Show fewer
  • 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.

Trial locations and contacts

14 sites in 1 country. Contact the study team or a site near you to ask about taking part.

14 sites in 1 country

United States14 sites

  • Erie County Medical Center

    Buffalo, New York, 14215

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Dallas Renal Group

    Dallas, Texas, 75230

  • Henry Ford Health

    Detroit, Michigan, 48202

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042

  • Eastern Carolina University, Brody School of Medicine

    Greenville, North Carolina, 27834

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Dartmouth

    Lebanon, New Hampshire, 03756

  • Cooperman Barnabas Medical Center

    Livingston, New Jersey, 07039

  • Keck Hospital of USC

    Los Angeles, California, 90033

  • UCLA

    Los Angeles, California, 90095

  • Intermountain Health

    Murray, Utah, 84107

  • Mayo Clinic Arizona

    Phoenix, Arizona, 85054

  • Atrium Health Wake Forest Baptist

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: A Prospective, Multicenter, Observational Study Evaluating Serial T-ID Monitoring for the Prevention of CMV Disease and BK Virus-Associated Nephropathy Following Kidney Transplantation

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).

Read the detailed description
  • 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.
Being tested
Blood tests, TRAC( cell free DNA) and T-ID
Keywords
Biomarkers testing, Kidney transplant rejection, T-ID Assay, TRAC Assay cell free DNA, Biopsy, dd-cfDNA, T-ID
Medical subject headings
Kidney Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood tests, TRAC( cell free DNA) and T-IDDiagnostic test

    Blood collection

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2026
  2. Study start19 May 2026
  3. Primary completion30 Apr 2028 (estimated)
  4. Study completion30 Oct 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07393594
Sponsor's protocol ID
TGRP32 ID-ENTITY
Acronym
ID-ENTITY
Status last verified
Oct 2026
First submitted
30 Jan 2026
Last updated
6 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: All data collected will be analyzed and submitted to Journals publications.

Publications

  • 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

  • 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.

    PubMed 29174434

  • 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.

    PubMed 38972761

  • 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.

    PubMed 34620649

  • 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.

    PubMed 29985559

  • 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.

    PubMed 24445740

  • 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.

    PubMed 23480233

  • 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.

    PubMed 32463180

Questions about this trial

What is this clinical trial studying?

An observational study of Kidney Diseases and Kidney Injury, run by Transplant Genomics, Inc. at 14 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: 12 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07393594, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.

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