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Liver Transplant RejectionNCT05335551

TRU-IMMUNO: Optimizing Liver Immunosuppression

An observational study of Liver Transplant Rejection, run by Transplant Genomics, Inc..

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a prospective, multi-center, randomized study. The primary objective is to evaluate the feasibility and utility of TruGraf/TRAC Liver testing used in addition to standard of care measures of liver dysfunction to guide immunosuppression management. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Liver Transplant Rejection
What is being tested?
Patients monitored with TruGraf and TRAC Liver testing
How many people
130 participants
Where
No sites listed yet
Study dates
May 2022to May 2023
Phase
Observational
Are there results?
None posted in the registry

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: -This study is an observational study in adult (age ≥ 18 years), liver transplant patients who are 1-2 months post-transplantation. Approximately 130 subjects will be enrolled.

Who may be able to join

  • At least 18 years of age.
  • Recipient of a primary or subsequent deceased-donor or living donor liver transplantation.
  • Normal liver function tests at the time of or within 2 weeks of the baseline visit, defined by Total Bilirubin (TB) ≤1.5 mg/dL and Direct Bilirubin (DB) <0.5 mg/dL, Alkaline Phosphatase (AP) ≤200 U/L, and Alanine Transaminase (ALT) ≤60 U/L (males) ≤36 U/L (females).
  • Between 1-2 months post-liver transplantation

Who cannot join

  • Inability or unwillingness to provide informed consent.
  • Recipients of previous hepatic or non-hepatic solid organ transplantation
  • History of ≥2 mild or moderate rejections or 1 severe rejection prior to enrollment defined by BANFF 2016 criteria
  • History of autoimmune liver disease
  • Listed for repeat liver transplantation
  • Infection with HIV
  • Active HBV or HCV viremia (patients with undetectable virus can be included)

Trial locations and contacts

No sites are listed yet.

Isioma Agboli, MD contact

15107678609

isiomaagboli@eurofins-tgi.com

About this study

Official title: A Clinical Pilot Study to Test the Acceptability and Feasibility of TruGraf Liver and TRAC Liver Testing as Part of Standard of Care: Optimizing Liver ImmunoSuppression (TRU-IMMUNO)

This is a prospective, multi-center, randomized study. The primary objective is to evaluate the feasibility and utility of TruGraf/TRAC Liver testing used in addition to standard of care measures of liver dysfunction to guide immunosuppression management.

Read the detailed description

This study will provide TruGraf Liver and TRAC liver tests to one group of transplant providers early after liver transplantation to clarify if the Trugraf Liver and TRAC Liver results can complement their immunosuppression minimization strategies to avoid complications and reduce the occurrence of acute rejection. The ability to decrease IS will be compared to the group that does not receive the test results.

Subjects will be randomized into 2 groups: one will receive Trugraf/TRAC Liver testing and the other will not. Subjects in the biomarker arm will have TruGraf Liver and TRAC Liver testing at study enrollment (1-2 months post-liver transplant) and thereafter every month for 6 months. Subjects will also have Trugraf Liver and TRAC Liver testing at months 9 and 12 following transplantation (7-8 and 10-11 months post baseline). The TruGraf and TRAC Liver results will be used in the biomarker arm in conjunction with all other clinical parameters available to guide decisions related to immunosuppression changes. There are no protocol mandated immunosuppression changes. Subjects in the standard of care arm will not have biomarkers available for decisions related to immunosuppression changes.

Being tested
Patients monitored with TruGraf and TRAC Liver testing
Keywords
Biomarkers, Subclinical Rejection, Immunosuppression

What participants receive

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

  • Patients monitored with TruGraf and TRAC Liver testingDiagnostic test

    This is an observational study there are no protocol mandated interventions. TruGraf and TRAC Liver results will be utilized in conjunction with standard of care assessments to determine patient management in the study arm.

Study groups in NCT05335551
Study groupRoleWhat they receive
Patients monitored with TruGraf/TRAC Liver testingSubjects in the biomarker arm will have TruGraf Liver and TRAC Liver testing at study enrollment (1-2 months post-liver transplant) and thereafter every month for 6 months. Subjects will also have Trugraf Liver and TRAC Liver testing at months 9 and 12 following transplantation (7-8 and 10-11 months postbaseline) The TruGraf and TRAC Liver results will be used in the biomarker arm in conjunction with all other clinical parameters available to guide decisions of the Principal Investigator and Sub-Investigators related to immunosuppression management. changes.
Receives: Diagnostic Test: Patients monitored with TruGraf and TRAC Liver testing
Patients not monitored with TruGraf/TRAC Liver testingPatients in control/ stamdard of care arm will have immusuppresion reduction based on the clinical judgement and management of the Principal Investigator and Sub-Investigators.

What is being measured

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

  1. Immunosuppression reduction

    Percent of subjects in each arm achieving at least 50% reduction from baseline total immunosuppressant (non-corticosteroid) dose at 6 months

    Measured: 6-months

Secondary outcomes (14)

  1. Immunosuppressant trough

    Immunosuppressant trough levels at 6 months post transplant

    Measured: 6-months

  2. Median and mean IS trough

    Median and mean change in IS trough levels from baseline to 6 months

    Measured: 6-months

  3. monotherapy immunosuppression

    Percent of patients achieving monotherapy immunosuppression

    Measured: 1 year

  4. clinical utility

    Percent and total number of TruGraf Liver and TRAC Liver results that the PI identified as having clinical utility (Utility).

    Measured: 1 year

  5. Liver testing workflow

    Percent and total number of eligible patients for whom the PI was able to complete the entire TruGraf Liver and TRAC Liver testing workflow (Feasibility).

    Measured: 1 year

  6. CKD score

    Progression of CKD score managed by the KDIGO (Kidney Disease: Improving Global Outcomes) criteria from a scale of GI (normal kidney) to G5 (kidney failure)

    Measured: 1 year

  7. BPAR for-cause biopsy

    Incidence of biopsy proven acute rejection on a for cause biopsy at months 6 and 12

    Measured: 1 year

  8. Acute rejection

    Incidence of clinically treated acute rejection at months 6 and 12

    Measured: 1 year

  9. eGFR timepoints

    eGFR at months 6 and 12

    Measured: 1 year

  10. eGFR timepoint range

    eGFR change from baseline to months 6 and 12

    Measured: 1 year

  11. Slope of eGFR

    Slope of eGFR from baseline to months 6 and 12

    Measured: 1 year

  12. eGFR decline or progression of CKD

    Risk factors for eGFR decline or progression of CKD score

    Measured: 1 year

  13. Infections

    Incidence of grade 3 or greater infections at months 6 and 12

    Measured: 1 year

  14. SF-36 scores

    Change in SF-36 scores from baseline to 6 months and end of study (SF 36 is a 36-item patient-reported questionnaire that covers eight health domains: physical functioning (10 items), bodily pain (2 items), role limitations due to physical health problems (4 items), role limitations due to personal or emotional problems (4 items), emotional well-being (5 items), social functioning (2 items), energy/fatigue (4 items), and general health perceptions (5 items). Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state.

    Measured: 1 year

Timeline

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

  1. First posted19 Apr 2022
  2. Study startMay 2022 (estimated)
  3. Primary completionMay 2023 (estimated)
  4. Study completionMay 2023 (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
130 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05335551
Sponsor's protocol ID
TGRP09
Status last verified
Apr 2022
First submitted
12 Apr 2022
Last updated
2 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Shaked A, DesMarais MR, Kopetskie H, Feng S, Punch JD, Levitsky J, Reyes J, Klintmalm GB, Demetris AJ, Burrell BE, Priore A, Bridges ND, Sayre PH. Outcomes of immunosuppression minimization and withdrawal early after liver transplantation. Am J Transplant. 2019 May;19(5):1397-1409. doi: 10.1111/ajt.15205. Epub 2018 Dec 31.

    PubMed 30506630

  • Fischer L, Klempnauer J, Beckebaum S, Metselaar HJ, Neuhaus P, Schemmer P, Settmacher U, Heyne N, Clavien PA, Muehlbacher F, Morard I, Wolters H, Vogel W, Becker T, Sterneck M, Lehner F, Klein C, Kazemier G, Pascher A, Schmidt J, Rauchfuss F, Schnitzbauer A, Nadalin S, Hack M, Ladenburger S, Schlitt HJ. A randomized, controlled study to assess the conversion from calcineurin-inhibitors to everolimus after liver transplantation--PROTECT. Am J Transplant. 2012 Jul;12(7):1855-65. doi: 10.1111/j.1600-6143.2012.04049.x. Epub 2012 Apr 11.

    PubMed 22494671

  • Sterneck M, Kaiser GM, Heyne N, Richter N, Rauchfuss F, Pascher A, Schemmer P, Fischer L, Klein CG, Nadalin S, Lehner F, Settmacher U, Neuhaus P, Gotthardt D, Loss M, Ladenburger S, Paulus EM, Mertens M, Schlitt HJ. Everolimus and early calcineurin inhibitor withdrawal: 3-year results from a randomized trial in liver transplantation. Am J Transplant. 2014 Mar;14(3):701-10. doi: 10.1111/ajt.12615. Epub 2014 Feb 6.

    PubMed 24502384

  • Levitsky J, Asrani SK, Schiano T, Moss A, Chavin K, Miller C, Guo K, Zhao L, Kandpal M, Bridges N, Brown M, Armstrong B, Kurian S, Demetris AJ, Abecassis M; Clinical Trials in Organ Transplantation - 14 Consortium. Discovery and validation of a novel blood-based molecular biomarker of rejection following liver transplantation. Am J Transplant. 2020 Aug;20(8):2173-2183. doi: 10.1111/ajt.15953. Epub 2020 May 25.

    PubMed 32356368

  • Levitsky J, Kandpal M, Guo K, Zhao L, Kurian S, Whisenant T, Abecassis M. Prediction of Liver Transplant Rejection With a Biologically Relevant Gene Expression Signature. Transplantation. 2022 May 1;106(5):1004-1011. doi: 10.1097/TP.0000000000003895. Epub 2021 Jul 22.

    PubMed 34342962

  • Gielis EM, Ledeganck KJ, De Winter BY, Del Favero J, Bosmans JL, Claas FH, Abramowicz D, Eikmans M. Cell-Free DNA: An Upcoming Biomarker in Transplantation. Am J Transplant. 2015 Oct;15(10):2541-51. doi: 10.1111/ajt.13387. Epub 2015 Jul 16.

    PubMed 26184824

  • Sharon E, Shi H, Kharbanda S, Koh W, Martin LR, Khush KK, Valantine H, Pritchard JK, De Vlaminck I. Quantification of transplant-derived circulating cell-free DNA in absence of a donor genotype. PLoS Comput Biol. 2017 Aug 3;13(8):e1005629. doi: 10.1371/journal.pcbi.1005629. eCollection 2017 Aug.

    PubMed 28771616

  • Levitsky J, Kandpal M, Guo K, Kleiboeker S, Sinha R, Abecassis M. Donor-derived cell-free DNA levels predict graft injury in liver transplant recipients. Am J Transplant. 2022 Feb;22(2):532-540. doi: 10.1111/ajt.16835. Epub 2021 Sep 24.

    PubMed 34510731

  • Charlton M, Levitsky J, Aqel B, O'Grady J, Hemibach J, Rinella M, Fung J, Ghabril M, Thomason R, Burra P, Little EC, Berenguer M, Shaked A, Trotter J, Roberts J, Rodriguez-Davalos M, Rela M, Pomfret E, Heyrend C, Gallegos-Orozco J, Saliba F. International Liver Transplantation Society Consensus Statement on Immunosuppression in Liver Transplant Recipients. Transplantation. 2018 May;102(5):727-743. doi: 10.1097/TP.0000000000002147.

    PubMed 29485508

  • Levitsky J, O'Leary JG, Asrani S, Sharma P, Fung J, Wiseman A, Niemann CU. Protecting the Kidney in Liver Transplant Recipients: Practice-Based Recommendations From the American Society of Transplantation Liver and Intestine Community of Practice. Am J Transplant. 2016 Sep;16(9):2532-44. doi: 10.1111/ajt.13765. Epub 2016 Apr 22.

    PubMed 26932352

Questions about this trial

What is this clinical trial studying?

An observational study of Liver Transplant Rejection, 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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 2 May 2022. 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?

Results are not available in the source record.

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

Contact Isioma Agboli, MD (15107678609, isiomaagboli@eurofins-tgi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Immunosuppression reduction (time frame: 6-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 NCT05335551, which also lists 10 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 2 May 2022.

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