PIONEER Trial (Post-Transplant Application of TruGraf and TRAC Molecular Panel in Renal Transplant Recipients)

NCT07231328 | Not Yet Recruiting DMC

• 1 other identifier: TGRP20_PIONEER
• Study Type: observational
• Target: 600
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is an observational, prospective, multi-center trial designed to evaluate clinical outcomes in kidney transplant recipients undergoing TruGraf and TRAC monitoring. Approximately 15 U.S. sites

Conditions

Immunosuppression Management; Biomarkers / Blood; Subclinical Rejection; Biopsy; Kidney Transplant Rejection

Keywords

TRAC-ID ASSAY; Kidney Transplant rejection; TruGraf, TRAC/TRAC ID biomarker panel; TruGraf; TRAC

Outcome Measures

Primary Outcomes (1)

• To evaluate post-transplant clinical outcomes in recipients of kidney transplants who are undergoing TruGraf and TRAC™ monitoring

  The primary endpoint is a composite at 24-months post-transplant, defined as the occurrence of any of the following events: • Biopsy-proven acute rejection (BPAR) on any for-cause biopsy between Month 1 to Month 24 (local read). OR • De novo Class I or Class II DSA detected at Month 12 or Month 24 (centrally read). OR • Decline in eGFR ≥20% from Month 3 to Month 24, calculated using the CKD-EPI creatinine-based equation. OR • Three or more abnormal TruGraf and TRAC results between Months 1 and 24

  24 Months post transplant

Secondary Outcomes (3)

• To evaluate the overall safety of TruGraf and TRAC monitoring in post-transplant recipients of kidney transplants.

  Month 3 to Mo 24 post transplant

• To asses the safety of a double negative TruGraf/TRAC result

  Month 3 to Mo 24 post transplant

• To explore the impact of biomarker -informed clinical decision-making on outcomes such as BPAR, estimated glomerular filtration rate (eGFR) trajectory, and immunosuppressive adjustments

  Month 3 to Mo 24 post transplant

Other Outcomes (1)

• Exploratory objective: Evaluate the utility of serial TRAC-ID assays to monitor viral or systemic infections and guide safe adjustments of immunosuppression

  Mont 3- Mo 24

Study Arms (2)

Natural History Subgroup

Diagnostic Test: There is no required Intervention for this Protocol. Based on Results for TruGraf/TRAC/TRAC ID Investigators may use the results in managing subjects Immunosuppression or rule out rejection.

• Real-World Use Subgroup

Diagnostic Test: There is no required Intervention for this Protocol. Based on Results for TruGraf/TRAC/TRAC ID Investigators may use the results in managing subjects Immunosuppression or rule out rejection.

Interventions

There is no required Intervention for this Protocol. Based on Results for TruGraf/TRAC/TRAC ID Investigators may use the results in managing subjects Immunosuppression or rule out rejection. DIAGNOSTIC_TEST

Investigators will prospectively record whether each results led to a change in clinical management. Participating sites will be encouraged to follow their usual practice, supplemented where appropriate by the suggested TruGraf and TRAC™ TRAC ID algorithms

Natural History Subgroup; • Real-World Use Subgroup

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study population- Post kidney transplant subjects 18 and older at leas 30 days post surgery will undergo TruGraf, TRAC and TRAC-ID biomarker testing at Mo 1,4,7,10,12,16,20 and 24.

You may qualify if:

• Able to understand the key components of the study as described in the written informed consent document and willing and able to provide written informed consent.
• At least 18 years of age at the time of screening.
• Enrollment begins 30 days prior to transplant till day 29 post-transplantation.
• Recipient of a kidney transplant (either primary or repeat), from either deceased or living donor.
• Receiving any immunosuppressive regimen.
• Able and willing to comply with all study procedures, as assessed by the Investigator.
• Selected by the treating provider to undergo TruGraf and TRAC™ testing as part of routine post-transplant care

You may not qualify if:

• History of previous non-kidney solid organ, vascular composite allograft, pancreatic islet, stem cell, or bone marrow transplant.
• History of dual or en-bloc kidney transplants.
• Recipient or donor with positive test for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis B virus (HBV) nucleic acid testing (NAT), hepatitis C virus (HCV) antibody, HCV NAT, human immunodeficiency virus (HIV), or HIV NAT.
• Patients known to be pregnant or with plans to become pregnant over the 24 months after enrollment.
• History or presence of coagulopathy, thrombophilia, unexplained bleeding or clotting disorders, or use of or documented plans for use of systemic anticoagulants at the time of screening, with the exception of uremic coagulopathy or prophylactic heparin preparations.
• History or presence, upon clinical evaluation, of any illness or condition that, in the opinion of the Investigator, would interfere with the ability to provide informed consent or comply with study instructions

Sponsors & Collaborators

• Transplant Genomics, Inc.: lead
• Medical University of South Carolina: collaborator
• Northwestern University: collaborator
• The Cleveland Clinic: collaborator
• University of Washington: collaborator
• University of California, Los Angeles: collaborator
• University of Nebraska: collaborator
• Duke University: collaborator
• University of Utah: collaborator
• Georgetown University: collaborator
• Virginia Commonwealth University: collaborator
• The Methodist Hospital Research Institute: collaborator
• Keck School of Medicine USC: collaborator
• Weill Medical College of Cornell University: collaborator
• Erie County Medical Center: collaborator
• East Carolina University: collaborator
• AdventHealth: collaborator

Related Publications (22)

• 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

• Analytical and Clinical Validation of a Molecular Diagnostic Signature in Kidney Transplant Recipients January 2017 Journal of Transplantation Technologies & Research 07(03) DOI: 10.4172/2161-0991.1000176

  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: 24445740 BACKGROUND

• 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: 23480233 BACKGROUND

• Loupy A, Vernerey D, Tinel C, Aubert O, Duong van Huyen JP, Rabant M, Verine J, Nochy D, Empana JP, Martinez F, Glotz D, Jouven X, Legendre C, Lefaucheur C. Subclinical Rejection Phenotypes at 1 Year Post-Transplant and Outcome of Kidney Allografts. J Am Soc Nephrol. 2015 Jul;26(7):1721-31. doi: 10.1681/ASN.2014040399. Epub 2015 Jan 2.

  PMID: 25556173 BACKGROUND

• Heilman RL, Devarapalli Y, Chakkera HA, Mekeel KL, Moss AA, Mulligan DC, Mazur MJ, Hamawi K, Williams JW, Reddy KS. Impact of subclinical inflammation on the development of interstitial fibrosis and tubular atrophy in kidney transplant recipients. Am J Transplant. 2010 Mar;10(3):563-70. doi: 10.1111/j.1600-6143.2009.02966.x. Epub 2010 Feb 1.

  PMID: 20121731 BACKGROUND

• Mehta RB, Tandukar S, Jorgensen D, Randhawa P, Sood P, Puttarajappa C, Zeevi A, Tevar AD, Hariharan S. Early subclinical tubulitis and interstitial inflammation in kidney transplantation have adverse clinical implications. Kidney Int. 2020 Aug;98(2):436-447. doi: 10.1016/j.kint.2020.03.028. Epub 2020 Apr 25.

  PMID: 32624181 BACKGROUND

• Mehta R, Bhusal S, Randhawa P, Sood P, Cherukuri A, Wu C, Puttarajappa C, Hoffman W, Shah N, Mangiola M, Zeevi A, Tevar AD, Hariharan S. Short-term adverse effects of early subclinical allograft inflammation in kidney transplant recipients with a rapid steroid withdrawal protocol. Am J Transplant. 2018 Jul;18(7):1710-1717. doi: 10.1111/ajt.14627. Epub 2018 Jan 17.

  PMID: 29247472 BACKGROUND

• Arias M, Seron D, Herrero I, Rush DN, Wiebe C, Nickerson PW, Ussetti P, Rodrigo E, de Cos MA. Subclinical Antibody-Mediated Rejection. Transplantation. 2017 Jun;101(6S Suppl 1):S1-S18. doi: 10.1097/TP.0000000000001735. No abstract available.

  PMID: 28538291 BACKGROUND

• Seifert ME, Yanik MV, Feig DI, Hauptfeld-Dolejsek V, Mroczek-Musulman EC, Kelly DR, Rosenblum F, Mannon RB. Subclinical inflammation phenotypes and long-term outcomes after pediatric kidney transplantation. Am J Transplant. 2018 Sep;18(9):2189-2199. doi: 10.1111/ajt.14933. Epub 2018 Jun 27.

  PMID: 29766640 BACKGROUND

• Nankivell BJ, Agrawal N, Sharma A, Taverniti A, P'Ng CH, Shingde M, Wong G, Chapman JR. The clinical and pathological significance of borderline T cell-mediated rejection. Am J Transplant. 2019 May;19(5):1452-1463. doi: 10.1111/ajt.15197. Epub 2019 Jan 22.

  PMID: 30501008 BACKGROUND

• Meier-Kriesche HU, Schold JD, Srinivas TR, Kaplan B. Lack of improvement in renal allograft survival despite a marked decrease in acute rejection rates over the most recent era. Am J Transplant. 2004 Mar;4(3):378-83. doi: 10.1111/j.1600-6143.2004.00332.x.

  PMID: 14961990 BACKGROUND

• Saran R, Robinson B, Abbott KC, Agodoa LY, Albertus P, Ayanian J, Balkrishnan R, Bragg-Gresham J, Cao J, Chen JL, Cope E, Dharmarajan S, Dietrich X, Eckard A, Eggers PW, Gaber C, Gillen D, Gipson D, Gu H, Hailpern SM, Hall YN, Han Y, He K, Hebert H, Helmuth M, Herman W, Heung M, Hutton D, Jacobsen SJ, Ji N, Jin Y, Kalantar-Zadeh K, Kapke A, Katz R, Kovesdy CP, Kurtz V, Lavalee D, Li Y, Lu Y, McCullough K, Molnar MZ, Montez-Rath M, Morgenstern H, Mu Q, Mukhopadhyay P, Nallamothu B, Nguyen DV, Norris KC, O'Hare AM, Obi Y, Pearson J, Pisoni R, Plattner B, Port FK, Potukuchi P, Rao P, Ratkowiak K, Ravel V, Ray D, Rhee CM, Schaubel DE, Selewski DT, Shaw S, Shi J, Shieu M, Sim JJ, Song P, Soohoo M, Steffick D, Streja E, Tamura MK, Tentori F, Tilea A, Tong L, Turf M, Wang D, Wang M, Woodside K, Wyncott A, Xin X, Zang W, Zepel L, Zhang S, Zho H, Hirth RA, Shahinian V. US Renal Data System 2016 Annual Data Report: Epidemiology of Kidney Disease in the United States. Am J Kidney Dis. 2017 Mar;69(3 Suppl 1):A7-A8. doi: 10.1053/j.ajkd.2016.12.004. No abstract available.

  PMID: 28236831 BACKGROUND

• Tonelli M, Wiebe N, Knoll G, Bello A, Browne S, Jadhav D, Klarenbach S, Gill J. Systematic review: kidney transplantation compared with dialysis in clinically relevant outcomes. Am J Transplant. 2011 Oct;11(10):2093-109. doi: 10.1111/j.1600-6143.2011.03686.x. Epub 2011 Aug 30.

  PMID: 21883901 BACKGROUND

• Peddi VR, Patel PS, Schieve C, Rose S, First MR. Serial Peripheral Blood Gene Expression Profiling to Assess Immune Quiescence in Kidney Transplant Recipients with Stable Renal Function. Ann Transplant. 2020 Apr 28;25:e920839. doi: 10.12659/AOT.920839.

  PMID: 32341330 BACKGROUND

• 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: 32463180 BACKGROUND

• Lee H, Colby C. Heat of polymerization of nine mono-, di-, and trimethacrylate esters tested neat and with low levels of peroxide by dynamic differential scanning calorimetry. Dent Mater. 1986 Aug;2(4):175-8. doi: 10.1016/s0109-5641(86)80031-8. No abstract available.

  PMID: 3462064 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: 29174434 BACKGROUND

• 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: 38972761 BACKGROUND

• 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: 34620649 BACKGROUND

• Zhang W, Yi Z, Keung KL, Shang H, Wei C, Cravedi P, Sun Z, Xi C, Woytovich C, Farouk S, Huang W, Banu K, Gallon L, Magee CN, Najafian N, Samaniego M, Djamali A, Alexander SI, Rosales IA, Smith RN, Xiang J, Lerut E, Kuypers D, Naesens M, O'Connell PJ, Colvin R, Menon MC, Murphy B. A Peripheral Blood Gene Expression Signature to Diagnose Subclinical Acute Rejection. J Am Soc Nephrol. 2019 Aug;30(8):1481-1494. doi: 10.1681/ASN.2018111098. Epub 2019 Jul 5.

  PMID: 31278196 BACKGROUND

• 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.

  PMID: 29985559 BACKGROUND

Related Links

• Related Info

Study Officials

• Isioma Agboli, MD

  Transplant Genomics

  STUDY DIRECTOR

Central Study Contacts

Isioma Agboli, Assistant Director, Clinical Programs, MD

CONTACT

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

Iulia Movileanu, Senior Clinical Trial Manager, MS CCRP

CONTACT

315-720-7289; Iulia.Movileanu@tgi.eurofinsus.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: November 17, 2025
• Study Start: November 20, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): March 31, 2029
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share