Evidence map›Paper›PMID 29985559›Full record

Observational studyAmerican journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons2019

Development and clinical validity of a novel blood-based molecular biomarker for subclinical acute rejection following kidney transplant.

John J Friedewald, Sunil M Kurian, Raymond L Heilman, Thomas C Whisenant, Emilio D Poggio, Christopher Marsh, Prabhakar Baliga, Jonah Odim, Merideth M Brown, David N Ikle and 9 more

3 registry-linked trialsAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 63 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
63citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05335538 unknown statusnot on this mapstarted 2021, after this paper: background citation

The Role of TruGraf® to Optimize Outcomes in Pediatric Renal Transplantation

TypeobservationalSponsorTransplant Genomics, Inc.Ran2021 to 2023Enrolled75ConditionsKidney Transplant RejectionArmsPatients monitored with TruGraf and TRAC testing
NCT07231328 not yet recruitingnot on this mapstarted 2025, after this paper: background citation

Post-Transplant Application of TruGraf and TRAC Molecular Panel in Renal Transplant Recipients

TypeobservationalSponsorTransplant Genomics, Inc.Ran2025 to 2029Enrolled600ConditionsImmunosuppression Management, Biomarkers / Blood, Subclinical Rejection, BiopsyArmsThere 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.
NCT07393594 not yet recruitingnot on this mapstarted 2026, after this paper: background citation

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

TypeobservationalSponsorTransplant Genomics, Inc.Ran2026 to 2028Enrolled1,000ConditionsKidney Diseases, Kidney Injury, BK Virus Infection, CMVArmsBlood tests, TRAC( cell free DNA) and T-ID
3 · Its place in the literature

Who cites it

63 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Effectiveness of T cell-mediated rejection therapy: A systematic review and meta-analysis.American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2022
    Pooled it
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. Review
  8. Review
  9. Review
  10. Noninvasive Diagnosis of Kidney Allograft Rejection.Journal of the American Society of Nephrology : JASN · 2025
    Review
  11. Article
  12. Article
  13. Review
  14. Article
  15. Article
  16. Review
  17. Article
  18. Biomarkers of Rejection in Kidney Transplantation.American journal of kidney diseases : the official journal of the National Kidney Foundation · 2025
    Review
  19. Review
  20. Article

3 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

19 authors.

John J FriedewaldNorthwestern University Feinberg School of Medicine, Chicago, IL, USA.
Sunil M KurianScripps Health, La Jolla, CA, USA.
Raymond L HeilmanMayo Clinic, Phoenix, AZ, USA.
Thomas C WhisenantUC San Diego Center for Computational Biology & Bioinformatics, San Diego, CA, USA.
Emilio D PoggioCleveland Clinic, Cleveland, OH, USA.
Christopher MarshScripps Health, La Jolla, CA, USA.
Prabhakar BaligaMedical University of South Carolina, Charleston, SC, USA.
Jonah OdimNational Institute of Allergy and Infectious Diseases, Bethesda, MD, USA.
Merideth M BrownNational Institute of Allergy and Infectious Diseases, Bethesda, MD, USA.
David N IkleRho Federal Systems, Chapel Hill, NC, USA.
Brian D ArmstrongRho Federal Systems, Chapel Hill, NC, USA.
Jane I CharetteNorthwestern University Feinberg School of Medicine, Chicago, IL, USA.
Susan S BrietigamNorthwestern University Feinberg School of Medicine, Chicago, IL, USA.
Nedjema Sustento-ReodicaNorthwestern University Feinberg School of Medicine, Chicago, IL, USA.
Lihui ZhaoNorthwestern University Feinberg School of Medicine, Chicago, IL, USA.
Manoj KandpalNorthwestern University Feinberg School of Medicine, Chicago, IL, USA.
Daniel R SalomonScripps Health, La Jolla, CA, USA.
Michael M AbecassisNorthwestern University Feinberg School of Medicine, Chicago, IL, USA.
Clinical Trials in Organ Transplantation 08 (CTOT-08)

Funding

Transplantation GroupUM2AI117870 · NIAID · RHO FEDERAL SYSTEMS DIVISION, INC. · PI DAVID, GLORIA · 2015 to 2023
$208.1M
Noninvasive Markers and Transplant Outcome in HumansU01AI063594 · NIAID · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · PI HEEGER, PETER SCOTT · 2004 to 2022
$66.5M
Quantitative Biology CoreU19AI063603 · NIAID · SCRIPPS RESEARCH INSTITUTE, THE · PI SCHORK, NICHOLAS JOSEPH · 2004 to 2015
$26.4M
Coordinating Center for Organ Transplant Clinical Trials (U01)U01AI088635 · NIAID · RHO FEDERAL SYSTEMS DIVISION, INC. · PI IKLE, DAVID N. · 2010 to 2014
$18.8M
Proteogenomics for Organ Transplantation: Prediction, Diagnosis, InterventionU01AI084146 · NIAID · NORTHWESTERN UNIVERSITY AT CHICAGO · PI ABECASSIS, MICHAEL M · 2009 to 2013
$10.5M
Effectiveness, Safety and Value of Integrating Molecular Diagnostics into the Post-Transplant Management of Kidney Transplant Recipients - The Next Frontier of Biomarker ResearchR34AI118493 · NIAID · NORTHWESTERN UNIVERSITY AT CHICAGO · PI ABECASSIS, MICHAEL M · 2015 to 2015
$280k
Comprehensive Transplant CenterNIAID NIH HHS R34 AI118493NIAID NIH HHS U01 AI063594NIAID NIH HHS U01 AI084146NIAID NIH HHS U01 AI088635NIAID NIH HHS U19 AI063603NIAID NIH HHS UM2 AI117870Transplant Genomics, Inc.
6 · The paper itself

Abstract

Noninvasive biomarkers are needed to monitor stable patients after kidney transplant (KT), because subclinical acute rejection (subAR), currently detectable only with surveillance biopsies, can lead to chronic rejection and graft loss. We conducted a multicenter study to develop a blood-based molecular biomarker for subAR using peripheral blood paired with surveillance biopsies and strict clinical phenotyping algorithms for discovery and validation. At a predefined threshold, 72% to 75% of KT recipients achieved a negative biomarker test correlating with the absence of subAR (negative predictive value: 78%-88%), while a positive test was obtained in 25% to 28% correlating with the presence of subAR (positive predictive value: 47%-61%). The clinical phenotype and biomarker independently and statistically correlated with a composite clinical endpoint (renal function, biopsy-proved acute rejection, ≥grade 2 interstitial fibrosis, and tubular atrophy), as well as with de novo donor-specific antibodies. We also found that <50% showed histologic improvement of subAR on follow-up biopsies despite treatment and that the biomarker could predict this outcome. Our data suggest that a blood-based biomarker that reduces the need for the indiscriminate use of invasive surveillance biopsies and that correlates with transplant outcomes could be used to monitor KT recipients with stable renal function, including after treatment for subAR, potentially improving KT outcomes.

Indexed as

Kidney TransplantationAdultAgedAlgorithmsBiomarkersBiopsyFemaleFibrosisGlomerular Filtration RateGraft RejectionGraft SurvivalHumansMaleMiddle AgedPhenotypePredictive Value of TestsBiomarkersalloantibodybiomarkerclinical research/practiceclinical trialgenomicskidney transplantation/nephrologyrejection: subclinicaltranslational research/science

Identifiers

PMID29985559
PMCPMC6387870

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.