Evidence map›Paper›PMID 35669974›Full record

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

Surrogate Endpoints for Late Kidney Transplantation Failure.

Maarten Naesens, Klemens Budde, Luuk Hilbrands, Rainer Oberbauer, Maria Irene Bellini, Denis Glotz, Josep Grinyó, Uwe Heemann, Ina Jochmans, Liset Pengel and 3 more

Abstract 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 20 papers.

0numbers the graph read from it
0cells of the map it votes in
20citing 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.

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

20 citing papers in PubMed.

  1. Selective impact on regulatory T cells with sustained functional phenotypes by the interleukin-2 mutein VIS171 in a nonhuman primate model.American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2026
    Article
  2. Article
  3. Article
  4. Article
  5. Article
  6. Review
  7. Competing and Noncompeting Risk Models for Predicting Kidney Allograft Failure.Journal of the American Society of Nephrology : JASN · 2025
    Article
  8. Early Post-Transplant Urinary EGF as a Potential Predictor of Long-Term Allograft Loss in Kidney Transplant Recipients.Transplant international : official journal of the European Society for Organ Transplantation · 2025
    Article
  9. Article
  10. 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
  11. Comparison of Kidney Graft Function and Survival in an Emulated Trial With Living Donors and Brain-Dead Donors.Transplant international : official journal of the European Society for Organ Transplantation · 2024
    Article
  12. Article
  13. Validation of a prediction system for risk of kidney allograft failure in pediatric kidney transplant recipients: An international observational study.American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2023
    Observational
  14. Embracing the Wisdom of Ancient Greece in the Era of Personalized Medicine-Uncertainty, Probabilistic Reasoning, and Democratic Consensus.Transplant international : official journal of the European Society for Organ Transplantation · 2023
    Article
  15. Article
  16. Qualifying a Novel Clinical Trial Endpoint (iBOX) Predictive of Long-Term Kidney Transplant Outcomes.Transplant international : official journal of the European Society for Organ Transplantation · 2023
    Article
  17. 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
  18. Review
  19. Allograft Function as Endpoint for Clinical Trials in Kidney Transplantation.Transplant international : official journal of the European Society for Organ Transplantation · 2022
    Article
  20. 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

13 authors.

Maarten NaesensDepartment of Microbiology, Immunology and Transplantation, KU Leuven, Leuven, Belgium.
Klemens BuddeDepartment of Nephrology and Medical Intensive Care, Charité Universitätsmedizin Berlin, Berlin, Germany.
Luuk HilbrandsDepartment of Nephrology, Radboud University Medical Center, Nijmegen, Netherlands.
Rainer OberbauerDepartment of Nephrology and Dialysis, Medical University of Vienna, Vienna, Austria.
Maria Irene BelliniDepartment of Surgical Sciences, Sapienza University of Rome, Rome, Italy.
Denis GlotzParis Translational Research Center for Organ Transplantation, Hôpital Saint Louis, Paris, France.
Josep GrinyóUniversity of Barcelona, Barcelona, Spain.
Uwe HeemannDepartment of Nephrology, Technical University of Munich, Munich, Germany.
Ina JochmansDepartment of Microbiology, Immunology and Transplantation, KU Leuven, Leuven, Belgium.
Liset PengelCentre for Evidence in Transplantation, Nuffield Department of Surgical Sciences, University of Oxford, Oxford, United Kingdom.
Marlies ReindersDepartment of Internal Medicine, Erasmus MC Transplant Institute, University Medical Center Rotterdam, Rotterdam, Netherlands.
Stefan SchneebergerDepartment of General, Transplant and Thoracic Surgery, Medical University of Innsbruck, Innsbruck, Austria.
Alexandre LoupyParis Translational Research Center for Organ Transplantation, Hôpital Necker, Paris, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In kidney transplant recipients, late graft failure is often multifactorial. In addition, primary endpoints in kidney transplantation studies seek to demonstrate the short-term efficacy and safety of clinical interventions. Although such endpoints might demonstrate short-term improvement in specific aspects of graft function or incidence of rejection, such findings do not automatically translate into meaningful long-term graft survival benefits. Combining many factors into a well-validated model is therefore more likely to predict long-term outcome and better reflect the complexity of late graft failure than using single endpoints. If conditional marketing authorization could be considered for therapies that aim to improve long-term outcomes following kidney transplantation, then the surrogate endpoint for graft failure in clinical trial settings needs clearer definition. This Consensus Report considers the potential benefits and drawbacks of several candidate surrogate endpoints (including estimated glomerular filtration rate, proteinuria, histological lesions, and donor-specific anti-human leukocyte antigen antibodies) and composite scoring systems. The content was created from information prepared by a working group within the European Society for Organ Transplantation (ESOT). The group submitted a Broad Scientific Advice request to the European Medicines Agency (EMA), June 2020: the request focused on clinical trial design and endpoints in kidney transplantation. Following discussion and refinement, the EMA made final recommendations to ESOT in December 2020 regarding the potential to use surrogate endpoints in clinical studies that aim to improving late graft failure.

Indexed as

Kidney TransplantationRenal InsufficiencyBiomarkersGlomerular Filtration RateGraft RejectionGraft SurvivalHLA AntigensHumansKidneyTransplant RecipientsBiomarkersHLA Antigensconditional marketing authorizationgraft functioniBoxoutcomerejection

Identifiers

PMID35669974
PMCPMC9163814

What OpenQuestion holds

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Registered trials

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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.