Immunosuppression ManagementPIONEERNCT07231328
PIONEER Trial (Post-Transplant Application of TruGraf and TRAC Molecular Panel in Renal Transplant Recipients)
An observational study of Immunosuppression Management and Biomarkers / Blood, run by Transplant Genomics, Inc..
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immunosuppression Management, Biomarkers / Blood, Subclinical Rejection
- What is being tested?
- 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.
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 20 Nov 2025to 31 Mar 2029
- 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
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Isioma Agboli, Assistant Director, Clinical Programs, MD contact
Iulia Movileanu, Senior Clinical Trial Manager, MS CCRP contact
About this study
Official title: Post-Transplant Application of TruGraf and TRAC Molecular Panel in Renal Transplant Recipients
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
Read the detailed description
All subjects who meet the inclusion criteria and none of the exclusion criteria will be eligible to participate. As the study is non-interventional, no protocol-mandated treatment or management plan will be imposed. In the absence of a universally ac-cepted paradigm for post-transplant monitoring with molecular diagnostics, participat-ing sites will be encouraged to follow their usual practice, supplemented where ap-propriate by the suggested TruGraf and TRAC™ algorithms.
To evaluate both the prognostic performance and the clinical utility of these bi-omarkers, a hybrid analytic framework will be used. Biomarker results will be made available to clinicians in real time, and investigators will prospectively record whether each result led to a change in clinical management. Natural History Subgroup: Test-ing events in which both TruGraf® and TRAC results are double-negative and no change in management occurred. Analyses will be anchored at the test-event level to avoid immortal time bias. This subgroup will be used to evaluate the safety and true negative predictive value (NPV) of a double-negative result, including the incidence of biopsy-proven acute rejection (BPAR) within 30 days.
- Real-World Use Subgroup: Testing events in which biomarker results prompt-ed a change in clinical management (e.g., change in immunosuppression, for-cause biopsy, or enhanced monitoring). By definition, any action following a test result places the event in this subgroup, irrespective of whether the bi-omarker result was double-negative or abnormal. Because clinical actions can alter subsequent risk trajectories, analyses in this subgroup will account for treatment-confounder feedback using causal modeling strategies (e.g., marginal structural models, target trial emulation).
- Conditions
- Immunosuppression Management, Biomarkers / Blood, Subclinical Rejection, Biopsy, Kidney Transplant Rejection
- Being tested
- 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.
- Keywords
- TRAC-ID ASSAY, Kidney Transplant rejection, TruGraf, TRAC/TRAC ID biomarker panel, TruGraf, TRAC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Natural History Subgroup | Not described Receives: 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 | Not described Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 Months post transplant
Secondary outcomes (3)
To evaluate the overall safety of TruGraf and TRAC monitoring in post-transplant recipients of kidney transplants.
Actions taken based on tests results TruGraf, TRAC/TRAC-ID
Measured: Month 3 to Mo 24 post transplant
To asses the safety of a double negative TruGraf/TRAC result
Quantifying the incidence of biopsy -proven acute rejection (BPAR) withing 30 days among patients for whom no change in clinical management was undertaken
Measured: 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
Quantifying the incidence of biopsy -proven acute rejection (BPAR) withing 30 days among patients for whom no change in clinical management was undertaken
Measured: Month 3 to Mo 24 post transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start20 Nov 2025 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Immunosuppression ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Time perspective
- Other
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Transplant Genomics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medical University of South Carolina, Northwestern University, The Cleveland Clinic, University of Washington, University of California, Los Angeles, University of Nebraska, Duke University, University of Utah, Georgetown University, Virginia Commonwealth University, The Methodist Hospital Research Institute, Keck School of Medicine USC, Weill Medical College of Cornell University, Erie County Medical Center, East Carolina University, AdventHealth
- Responsible party
- Sponsor
- Investigators
- Isioma Agboli, MD, Study director, Transplant Genomics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07231328
- Sponsor's protocol ID
- TGRP20_PIONEER
- Acronym
- PIONEER
- Status last verified
- Nov 2025
- First submitted
- 22 Sep 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Results and Statistical analysis will be shared with PI's and Internal steering committee for Journal publications. It will become available upon 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
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
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 24445740Bouamar 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 23480233Loupy 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.
PubMed 25556173Heilman 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.
PubMed 20121731Mehta 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.
PubMed 32624181Mehta 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.
PubMed 29247472Arias 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.
PubMed 28538291Seifert 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.
PubMed 29766640Nankivell 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.
PubMed 30501008Meier-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.
PubMed 14961990Saran 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.
PubMed 28236831Tonelli 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.
PubMed 21883901Peddi 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.
PubMed 32341330
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Transplant Application of TruGraf and TRAC Molecular Panel in Renal Transplant Recipients
- ClinicalTrials.gov ID
- NCT07231328
- Acronym / sponsor ID
- PIONEER / TGRP20_PIONEER
- 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
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Transplant Genomics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Medical University of South Carolina, Northwestern University, The Cleveland Clinic, University of Washington, University of California, Los Angeles, University of Nebraska, Duke University, University of Utah, Georgetown University, Virginia Commonwealth University, The Methodist Hospital Research Institute, Keck School of Medicine USC, Weill Medical College of Cornell University, Erie County Medical Center, East Carolina University, AdventHealth
- Study start
- 20 Nov 2025 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 17 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
All subjects who meet the inclusion criteria and none of the exclusion criteria will be eligible to participate. As the study is non-interventional, no protocol-mandated treatment or management plan will be imposed. In the absence of a universally ac-cepted paradigm for post-transplant monitoring with molecular diagnostics, participat-ing sites will be encouraged to follow their usual practice, supplemented where ap-propriate by the suggested TruGraf and TRAC™ algorithms.
To evaluate both the prognostic performance and the clinical utility of these bi-omarkers, a hybrid analytic framework will be used. Biomarker results will be made available to clinicians in real time, and investigators will prospectively record whether each result led to a change in clinical management. Natural History Subgroup: Test-ing events in which both TruGraf® and TRAC results are double-negative and no change in management occurred. Analyses will be anchored at the test-event level to avoid immortal time bias. This subgroup will be used to evaluate the safety and true negative predictive value (NPV) of a double-negative result, including the incidence of biopsy-proven acute rejection (BPAR) within 30 days.
- Real-World Use Subgroup: Testing events in which biomarker results prompt-ed a change in clinical management (e.g., change in immunosuppression, for-cause biopsy, or enhanced monitoring). By definition, any action following a test result places the event in this subgroup, irrespective of whether the bi-omarker result was double-negative or abnormal. Because clinical actions can alter subsequent risk trajectories, analyses in this subgroup will account for treatment-confounder feedback using causal modeling strategies (e.g., marginal structural models, target trial emulation).
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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.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 | Diagnostic test | Natural History Subgroup, • Real-World Use Subgroup |
Primary outcome
To evaluate post-transplant clinical outcomes in recipients of kidney transplants who are undergoing TruGraf and TRAC™ monitoring
Time frame: 24 Months post transplant
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
3 secondary outcomes
To evaluate the overall safety of TruGraf and TRAC monitoring in post-transplant recipients of kidney transplants.
Time frame: Month 3 to Mo 24 post transplant
To asses the safety of a double negative TruGraf/TRAC result
Time frame: 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
Time frame: Month 3 to Mo 24 post transplant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- BackgroundClinical 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
- BackgroundAnalytical 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: PubMed 24445740Lo 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.
- Background: PubMed 23480233Bouamar 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.
- Background: PubMed 25556173Loupy 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.
- Background: PubMed 20121731Heilman 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.
- Background: PubMed 32624181Mehta 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.
- Background: PubMed 29247472Mehta 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.
- Background: PubMed 28538291Arias 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.
- Background: PubMed 29766640Seifert 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.
- Background: PubMed 30501008Nankivell 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.
- Background: PubMed 14961990Meier-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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Results and Statistical analysis will be shared with PI's and Internal steering committee for Journal publications. It will become available upon publications
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Isioma Agboli, Assistant Director, Clinical Programs, MD contact
Iulia Movileanu, Senior Clinical Trial Manager, MS CCRP contact
Isioma Agboli, MD study director
Transplant Genomics
Questions about this trial
What is this clinical trial studying?
An observational study of Immunosuppression Management and Biomarkers / Blood, run by Transplant Genomics, Inc..
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 7 inclusion and 6 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: opening soon, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Isioma Agboli, Assistant Director, Clinical Programs, MD (510- 767-8609, isioma.agboli@tgi.eurofinsus.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate post-transplant clinical outcomes in recipients of kidney transplants who are undergoing TruGraf and TRAC™ monitoring (time frame: 24 Months post transplant). 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 NCT07231328, which also lists 22 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 17 Nov 2025.