Evidence map›Paper›PMID 35669976›Full record

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

Allograft Function as Endpoint for Clinical Trials in Kidney Transplantation.

Luuk Hilbrands, Klemens Budde, Maria Irene Bellini, Fritz Diekmann, Lucrezia Furian, Josep Grinyó, Uwe Heemann, Dennis A Hesselink, Alexandre Loupy, Rainer Oberbauer and 4 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 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
5.4field-weighted citation impact, top 4% 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

14 citing papers in PubMed, 1 synthesis or guideline pooled it, 27 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. A Retrospective Post-Marketing Surveillance Study on TGlobulin25Iranian journal of medical sciences · 2026
    Article
  4. Article
  5. Article
  6. Article
  7. Review
  8. Article
  9. Article
  10. Review
  11. Article
  12. Article
  13. 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
  14. Surrogate Endpoints for Late Kidney Transplantation Failure.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

14 authors at 12 institutions in 8 countries.

Luuk HilbrandsDepartment of Nephrology, Radboud University Medical Center, Nijmegen, Netherlands.
Klemens BuddeDepartment of Nephrology and Medical Intensive Care, Charité Universitätsmedizin Berlin, Berlin, Germany.
Maria Irene BelliniDepartment of Surgical Sciences, Sapienza University of Rome, Rome, Italy.
Fritz DiekmannDepartment of Nephrology and Kidney Transplantation, Vall d'Hebrón University Hospital, Barcelona, Spain.
Lucrezia FurianKidney and Pancreas Transplantation Unit, University of Padua, Padua, Italy.
Josep GrinyóDepartment of Clinical Sciences, University of Barcelona, Barcelona, Spain.
Uwe HeemannDepartment of Nephrology, Technical University of Munich, Munich, Germany.
Dennis A HesselinkDepartment of Internal Medicine, Erasmus MC Transplant Institute, University Medical Center Rotterdam, Rotterdam, Netherlands.
Alexandre LoupyParis Translational Research Center for Organ Transplantation, Hôpital Necker, Paris, France.
Rainer OberbauerDepartment of Nephrology and Dialysis, Medical University of Vienna, Vienna, Austria.
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.
Maarten NaesensDepartment of Microbiology, Immunology and Transplantation, KU Leuven, Leuven, Belgium.
Netherlands School of Public Administration · NLCharité - Universitätsmedizin Berlin · DEKU Leuven · BEMedical University of Vienna · ATNuffield Orthopaedic Centre · GBRadboud University Nijmegen · NLSapienza University of Rome · ITTechnical University of Munich · DETranslational Research in Oncology · FRUniversitat de Barcelona · ESUniversity of Padua · ITVall d'Hebron Hospital Universitari · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Clinical study endpoints that assess the efficacy of interventions in patients with chronic renal insufficiency can be adopted for use in kidney transplantation trials, given the pathophysiological similarities between both conditions. Kidney dysfunction is reflected in the glomerular filtration rate (GFR), and although a predefined (e.g., 50%) reduction in GFR was recommended as an endpoint by the European Medicines Agency (EMA) in 2016, many other endpoints are also included in clinical trials. End-stage renal disease is strongly associated with a change in estimated (e)GFR, and eGFR trajectories or slopes are increasingly used as endpoints in clinical intervention trials in chronic kidney disease (CKD). Similar approaches could be considered for clinical trials in kidney transplantation, although several factors should be taken into account. The present Consensus Report was developed from documentation produced by the European Society for Organ Transplantation (ESOT) as part of a Broad Scientific Advice request that ESOT submitted to the EMA in 2020. This paper provides a contemporary discussion of primary endpoints used in clinical trials involving CKD, including proteinuria and albuminuria, and evaluates the validity of these concepts as endpoints for clinical trials in kidney transplantation.

Indexed as

Kidney TransplantationRenal Insufficiency, ChronicAlbuminuriaAllograftsDisease ProgressionGlomerular Filtration RateHumansclinical studyendpointsgraft dysfunctiongraft functionkidney transplantation

Identifiers

PMID35669976
PMCPMC9163811
OpenAlexW4280633059

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.