Evidence map›Paper›PMID 35669978›Full record

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

Evolution of the Definition of Rejection in Kidney Transplantation and Its Use as an Endpoint in Clinical Trials.

Jan Ulrich Becker, Daniel Seron, Marion Rabant, Candice Roufosse, Maarten Naesens

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 13 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 2 pooled it
3.3field-weighted citation impact, top 8% 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

13 citing papers in PubMed, 2 syntheses or guidelines pooled it, 17 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. 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
  9. Article
  10. Article
  11. Alloimmune Risk Stratification for Kidney Transplant Rejection.Transplant international : official journal of the European Society for Organ Transplantation · 2022
    Article
  12. 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
  13. Proposed Definitions of T Cell-Mediated Rejection and Tubulointerstitial Inflammation as Clinical Trial Endpoints in Kidney Transplantation.Transplant international : official journal of the European Society for Organ Transplantation · 2022
    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

5 authors at 5 institutions in 5 countries.

Jan Ulrich BeckerInstitute of Pathology, University Hospital Cologne, Cologne, Germany.
Daniel SeronDepartment of Nephrology and Kidney Transplantation, Vall d'Hebrón University Hospital, Barcelona, Spain.
Marion RabantDepartment of Pathology, Hôpital Necker-Enfants Malades, Paris, France.
Candice RoufosseCentre for Inflammatory Disease, Department of Immunology and Inflammation, Imperial College London, London, United Kingdom.
Maarten NaesensDepartment of Microbiology, Immunology and Transplantation, KU Leuven, Leuven, Belgium.
Hôpital Necker-Enfants Malades · FRImperial College London · GBKU Leuven · BEUniversity Hospital Cologne · DEVall d'Hebron Hospital Universitari · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This article outlines the evolving definition of rejection following kidney transplantation. The viewpoints and evidence presented were included in documentation prepared for a Broad Scientific Advice request to the European Medicines Agency (EMA), relating to clinical trial endpoints in kidney transplantation. This request was initiated by the European Society for Organ Transplantation (ESOT) in 2016 and finalized following discussions between the EMA and ESOT in 2020. In ESOT's opinion, the use of "biopsy-proven acute rejection" as an endpoint for clinical trials in kidney transplantation is no longer accurate, although it is still the approved histopathological endpoint. The spectrum of rejection is now divided into the phenotypes of borderline changes, T cell-mediated rejection, and antibody-mediated rejection, with the latter two phenotypes having further subclassifications. Rejection is also described in relation to graft (dys)function, diagnosed because of protocol (surveillance) or indication (for-cause) biopsies. The ongoing use of outdated terminology has become a potential barrier to clinical research in kidney transplantation. This article presents these perspectives and issues, and provides a foundation on which subsequent articles within this Special Issue of Transplant International build.

Indexed as

Kidney TransplantationAntibodiesBiopsyGraft RejectionHumansKidneyT-LymphocytesAntibodiesantibody-mediated rejectionbiopsyborderline changeskidney transplantation outcomesubclinical rejectionT cell-mediated rejection

Identifiers

PMID35669978
PMCPMC9163319
OpenAlexW4280589088

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.