Evidence map›Paper›PMID 31378695›Full record

ArticleEBioMedicine2019

Development and validation of a peripheral blood mRNA assay for the assessment of antibody-mediated kidney allograft rejection: A multicentre, prospective study.

Elisabet Van Loon, Stéphane Gazut, Saleh Yazdani, Evelyne Lerut, Henriette de Loor, Maarten Coemans, Laure-Hélène Noël, Lieven Thorrez, Leentje Van Lommel, Frans Schuit and 7 more

2 registry-linked trialsAbstract readMulticenter Study
In one paragraph

Article in EBioMedicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 42 papers.

0numbers the graph read from it
0cells of the map it votes in
42citing papers in PubMed
–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.

NCT01331668 recruitingnot on this map

Biobank Renal Transplantation University Hospitals Leuven

TypeobservationalSponsorUniversitaire Ziekenhuizen KU LeuvenRan2004 to 2099Enrolled5,000ConditionsKidney Failure
NCT02832661 unknown statusnot on this map

BIOMARGIN European, Ambispective Cohort of Adult and Paediatric Renal Transplant Patients for the Evaluation of the Diagnostic and Prognostic Performance of Biomarkers of Renal Graft Injuries

TypeobservationalSponsorUniversity Hospital, LimogesRan2015 to 2020Enrolled500ConditionsKidney Transplantation
3 · Its place in the literature

Who cites it

42 citing papers in PubMed.

  1. Review
  2. Article
  3. Noninvasive Diagnosis of Kidney Allograft Rejection.Journal of the American Society of Nephrology : JASN · 2025
    Review
  4. Review
  5. [Therapeutic response and monitoring of antibody-mediated renal graft rejection].Revista medica del Instituto Mexicano del Seguro Social · 2025
    Article
  6. Biomarkers of Rejection in Kidney Transplantation.American journal of kidney diseases : the official journal of the National Kidney Foundation · 2025
    Review
  7. Immune Landscape in Kidney Transplantation.Journal of inflammation research · 2025
    Review
  8. Review
  9. Article
  10. Article
  11. Article
  12. Review
  13. Review
  14. European Society of Organ Transplantation Consensus Statement on Testing for Non-Invasive Diagnosis of Kidney Allograft Rejection.Transplant international : official journal of the European Society for Organ Transplantation · 2023
    Article
  15. Review
  16. Peripheral blood immune cell profiling of acute corneal transplant rejection.American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2022
    Article
  17. Article
  18. Article
  19. Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors.

Elisabet Van LoonDepartment of Microbiology, Immunology and Transplantation, Nephrology and Renal Transplantation Research Group, Leuven, Belgium; University Hospitals Leuven, Department of Nephrology and Renal Transplantation, Leuven, Belgium.
Stéphane GazutCEA, LIST, Laboratory for Data Analysis and Systems' Intelligence, Gif-sur-Yvette, France.
Saleh YazdaniDepartment of Microbiology, Immunology and Transplantation, Nephrology and Renal Transplantation Research Group, Leuven, Belgium.
Evelyne LerutUniversity Hospitals Leuven, Department of Morphology and Molecular Pathology, Leuven, Belgium.
Henriette de LoorDepartment of Microbiology, Immunology and Transplantation, Nephrology and Renal Transplantation Research Group, Leuven, Belgium.
Maarten CoemansDepartment of Microbiology, Immunology and Transplantation, Nephrology and Renal Transplantation Research Group, Leuven, Belgium.
Laure-Hélène NoëlNecker-Enfants Malades Institute, French National Institute of Health and Medical Research U1151, France.
Lieven ThorrezKU Leuven Department of Development and Regeneration, campus KULAK, Kortrijk, Belgium.
Leentje Van LommelKU Leuven Gene Expression Unit, Department of Cellular and Molecular Medicine, Leuven, Belgium.
Frans SchuitKU Leuven Gene Expression Unit, Department of Cellular and Molecular Medicine, Leuven, Belgium.
Ben SprangersDepartment of Microbiology, Immunology and Transplantation, Nephrology and Renal Transplantation Research Group, Leuven, Belgium; University Hospitals Leuven, Department of Nephrology and Renal Transplantation, Leuven, Belgium; KU Leuven Laboratory of Molecular Immunology, Rega Institute, Leuven, Belgium.
Dirk KuypersDepartment of Microbiology, Immunology and Transplantation, Nephrology and Renal Transplantation Research Group, Leuven, Belgium; University Hospitals Leuven, Department of Nephrology and Renal Transplantation, Leuven, Belgium.
Marie EssigCHU Limoges, Department of Nephrology, Dialysis and Transplantation, Univ. Limoges, U850 INSERM, Limoges, France.
Wilfried GwinnerDepartment of Nephrology, Hannover Medical School, Hannover, Germany.
Dany AnglicheauParis Descartes, Sorbonne Paris Cité University, INSERM U1151, Paris, France; Department of Nephrology and Kidney Transplantation, RTRS Centaure, Necker Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France.
Pierre MarquetCHU Limoges, Univ. Limoges, U850 INSERM, Limoges, France.
Maarten NaesensDepartment of Microbiology, Immunology and Transplantation, Nephrology and Renal Transplantation Research Group, Leuven, Belgium; University Hospitals Leuven, Department of Nephrology and Renal Transplantation, Leuven, Belgium. Electronic address: maarten.naesens@kuleuven.be.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAntibody-mediated rejection, a leading cause of renal allograft graft failure, is diagnosed by histological assessment of invasive allograft biopsies. Accurate non-invasive biomarkers are not available.

methodsIn the multicentre, prospective BIOMARGIN study, blood samples were prospectively collected at time of renal allograft biopsies between June 2011 and August 2016 and analyzed in three phases. The discovery and derivation phases of the study (N = 117 and N = 183 respectively) followed a case-control design and included whole genome transcriptomics and targeted mRNA expression analysis to construct and lock a multigene model. The primary end point was the diagnostic accuracy of the locked multigene assay for antibody-mediated rejection in a third validation cohort of serially collected blood samples (N = 387). This trial is registered with ClinicalTrials.gov, number NCT02832661.

findingsWe identified and locked an 8-gene assay (CXCL10, FCGR1A, FCGR1B, GBP1, GBP4, IL15, KLRC1, TIMP1) in blood samples from the discovery and derivation phases for discrimination between cases with (N = 49) and without (N = 134) antibody-mediated rejection. In the validation cohort, this 8-gene assay discriminated between cases with (N = 41) and without antibody-mediated rejection (N = 346) with good diagnostic accuracy (ROC AUC 79·9%; 95% CI 72·6 to 87·2, p < 0·0001). The diagnostic accuracy of the 8-gene assay was retained both at time of stable graft function and of graft dysfunction, within the first year and also later after transplantation. The 8-gene assay is correlated with microvascular inflammation and transplant glomerulopathy, but not with the histological lesions of T-cell mediated rejection.

interpretationWe identified and validated a novel 8-gene expression assay that can be used for non-invasive diagnosis of antibody-mediated rejection.

fundingThe Seventh Framework Programme (FP7) of the European Commission.

Indexed as

BiomarkersCell-Free Nucleic AcidsAdultAntibodiesFemaleGraft RejectionHumansKidney TransplantationLiquid BiopsyMaleMiddle AgedPrognosisProspective StudiesReproducibility of ResultsRNA, MessengerROC CurveAntibodiesBiomarkersCell-Free Nucleic AcidsRNA, MessengerAntibody-mediated rejectionBiomarkerKidney transplantation

Identifiers

PMID31378695
PMCPMC6710906

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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.