Evidence map›Paper›PMID 35669973›Full record

ArticleTransplant international : official journal of the European Society for Organ Transplantation2022

Proposed Definitions of Antibody-Mediated Rejection for Use as a Clinical Trial Endpoint in Kidney Transplantation.

Candice Roufosse, Jan Ulrich Becker, Marion Rabant, Daniel Seron, Maria Irene Bellini, Georg A Böhmig, Klemens Budde, Fritz Diekmann, Denis Glotz, Luuk Hilbrands and 5 more

Open access · goldAbstract readEditorial
In one paragraph

Article in Transplant international : official journal of the European Society for Organ Transplantation, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
2.9field-weighted citation impact, top 9% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 14 citations in OpenAlex.

  1. Review
  2. Kidney transplant arteriopathy revisited.Journal of nephrology · 2025
    Article
  3. Article
  4. Antibody-mediated rejection-treatment standard.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2025
    Review
  5. Article
  6. Review
  7. The Banff 2022 Kidney Meeting Work Plan: Data-driven refinement of the Banff Classification for renal allografts.American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2024
    Article
  8. Article
  9. Rationale for Surrogate Endpoints and Conditional Marketing Authorization of New Therapies for Kidney Transplantation.Transplant international : official journal of the European Society for Organ Transplantation · 2022
    Review
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

15 authors at 10 institutions in 7 countries.

Candice RoufosseDepartment of Immunology and Inflammation, Centre for Inflammatory Disease, Imperial College London, London, United Kingdom.
Jan Ulrich BeckerInstitute of Pathology, University Hospital Cologne, Cologne, Germany.
Marion RabantDepartment of Pathology, Hôpital Necker-Enfants Malades, Paris, France.
Daniel SeronDepartment of Nephrology and Kidney Transplantation, Vall d'Hebrón University Hospital, Barcelona, Spain.
Maria Irene BelliniDepartment of Surgical Sciences, Sapienza University of Rome, Rome, Italy.
Georg A BöhmigDivision of Nephrology and Dialysis, Department of Internal Medicine, Medical University of Vienna, Vienna, Austria.
Klemens BuddeDepartment of Nephrology and Medical Intensive Care, Charité Universitätsmedizin Berlin, Berlin, Germany.
Fritz DiekmannDepartment of Nephrology and Kidney Transplantation, Hospital Clinic Barcelona, Barcelona, Spain.
Denis GlotzParis Translational Research Center for Organ Transplantation, Hôpital Saint Louis, Paris, France.
Luuk HilbrandsDepartment of Nephrology, Radboud University Medical Center, Nijmegen, Netherlands.
Alexandre LoupyParis Translational Research Center for Organ Transplantation, Hôpital Necker, Paris, France.
Rainer OberbauerDivision of Nephrology and Dialysis, Department of Internal Medicine, Medical University of Vienna, Vienna, Austria.
Liset PengelCentre for Evidence in Transplantation, University of Oxford, Oxford, United Kingdom.
Stefan SchneebergerDepartment of General, Transplant and Thoracic Surgery, Medical University of Innsbruck, Innsbruck, Austria.
Maarten NaesensDepartment of Microbiology, Immunology and Transplantation, KU Leuven, Leuven, Belgium.
Translational Research in Oncology · FRCentre for Inflammation Research · GBCharité - Universitätsmedizin Berlin · DEHôpital Necker-Enfants Malades · FRHospital Clínic de Barcelona · ESInstitute of Clinical Cancer Research · DEKU Leuven · BERadboud University Medical Center · NLSapienza University of Rome · ITVall d'Hebron Hospital Universitari · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Antibody-mediated rejection (AMR) is caused by antibodies that recognize donor human leukocyte antigen (HLA) or other targets. As knowledge of AMR pathophysiology has increased, a combination of factors is necessary to confirm the diagnosis and phenotype. However, frequent modifications to the AMR definition have made it difficult to compare data and evaluate associations between AMR and graft outcome. The present paper was developed following a Broad Scientific Advice request from the European Society for Organ Transplantation (ESOT) to the European Medicines Agency (EMA), which explored whether updating guidelines on clinical trial endpoints would encourage innovations in kidney transplantation research. ESOT considers that an AMR diagnosis must be based on a combination of histopathological factors and presence of donor-specific HLA antibodies in the recipient. Evidence for associations between individual features of AMR and impaired graft outcome is noted for microvascular inflammation scores ≥2 and glomerular basement membrane splitting of >10% of the entire tuft in the most severely affected glomerulus. Together, these should form the basis for AMR-related endpoints in clinical trials of kidney transplantation, although modifications and restrictions to the Banff diagnostic definition of AMR are proposed for this purpose. The EMA provided recommendations based on this Broad Scientific Advice request in December 2020; further discussion, and consensus on the restricted definition of the AMR endpoint, is required.

Indexed as

Kidney TransplantationAntibodiesBiopsyGraft RejectionHLA AntigensHumansIsoantibodiesAntibodiesHLA AntigensIsoantibodiesantibody-mediated rejectionbiopsyEMA guidelinehistologykidney transplantationoutcomes

Identifiers

PMID35669973
PMCPMC9163810
OpenAlexW4285744843

What OpenQuestion holds

Textmetadata
LicenceCC BY
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Registered trials

None linked

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.