Evidence map›Paper›PMID 35450886›Full record

ArticleBMJ open2022

Study protocol: the TRAnsplant BIOpsies (TRABIO) study - a prospective, observational, multicentre cohort study to assess the treatment of kidney graft rejections.

Friedrich Alexander von Samson-Himmelstjerna, Grit Esser, Kevin Schulte, Benedikt Kolbrink, Markus Krautter, Vedat Schwenger, Julia Weinmann-Menke, Julia Matschkal, Florian Schraml, Anne Pahl and 7 more

Abstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Review
  2. 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.

Friedrich Alexander von Samson-Himmelstjerna *Department of Nephrology & Hypertension, University Hospital Schleswig-Holstein - Campus Kiel, Kiel, Germany friedrich.vonsamson-himmelstjerna@uksh.de.ORCID 0000-0002-4492-696X
Grit Esser *Department of Nephrology & Hypertension, University Hospital Schleswig-Holstein - Campus Kiel, Kiel, Germany.
Kevin SchulteDepartment of Nephrology & Hypertension, University Hospital Schleswig-Holstein - Campus Kiel, Kiel, Germany.
Benedikt KolbrinkDepartment of Nephrology & Hypertension, University Hospital Schleswig-Holstein - Campus Kiel, Kiel, Germany.
Markus KrautterTransplant Center, Department of Nephrology, Klinikum Stuttgart, Stuttgart, Germany.
Vedat SchwengerTransplant Center, Department of Nephrology, Klinikum Stuttgart, Stuttgart, Germany.
Julia Weinmann-MenkeDepartment of Nephrology, University Medical Center Mainz, Department of Internal Medicine I, Mainz, Germany.
Julia MatschkalDepartment of Nephrology, Klinikum rechts der Isar, Technical University of Munich, School of Medicine, München, Germany.
Florian SchramlDepartment of Nephrology, Klinikum rechts der Isar, Technical University of Munich, School of Medicine, München, Germany.
Anne PahlDepartment of Nephrology, Klinikum rechts der Isar, Technical University of Munich, School of Medicine, München, Germany.
Matthias BraunischDepartment of Nephrology, Klinikum rechts der Isar, Technical University of Munich, School of Medicine, München, Germany.
Kerstin AmannDepartment of Nephropathology, University Hospital Erlangen, University of Erlangen-Nürnberg, Erlangen, Germany.
Thorsten FeldkampDepartment of Nephrology & Hypertension, University Hospital Schleswig-Holstein - Campus Kiel, Kiel, Germany.
Ulrich KunzendorfDepartment of Nephrology & Hypertension, University Hospital Schleswig-Holstein - Campus Kiel, Kiel, Germany.
Lutz RendersDepartment of Nephrology, Klinikum rechts der Isar, Technical University of Munich, School of Medicine, München, Germany.
Uwe HeemannDepartment of Nephrology, Klinikum rechts der Isar, Technical University of Munich, School of Medicine, München, Germany.
TRABIO Study Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionDespite continued efforts, long-term outcomes of kidney transplantation remain unsatisfactory. Kidney graft rejections are independent risk factors for graft failure. At the participating centres of the TRAnsplant BIOpsies study group, a common therapeutic standard has previously been defined for the treatment of graft rejections. The outcomes of this strategy will be assessed in a prospective, observational cohort study. METHODS AND ANALYSIS: A total of 800 kidney transplantation patients will be enrolled who undergo a graft biopsy because of deteriorating kidney function. Patients will be stratified according to the Banff classification, and the influence of the treatment strategy on end points will be assessed using regression analysis. Primary end points will be all-cause mortality and graft survival. Secondary end points will be worsening of kidney function (≥30% decline of estimated Glomerular Filtration Rate [eGFR] or new-onset large proteinuria), recurrence of graft rejection and treatment response. Baseline data and detailed histopathology data will be entered into an electronic database on enrolment. During a first follow-up period (within 14 days) and subsequent yearly follow-ups (for 5 years), treatment strategies and clinical course will be recorded. Recruitment at the four participating centres started in September 2016. As of August 2020, 495 patients have been included. ETHICS AND DISSEMINATION: Ethical approval for the study has been obtained from the ethics committee of Kiel (AZ B 278/16) and was confirmed by the committees of Munich, Mainz and Stuttgart. The results will be reported in a peer-reviewed journal, according to the Strengthening the Reporting of Observational Studies in Epidemiology criteria. TRIAL REGISTRATION NUMBER: ISRCTN78772632; Pre-results.

Indexed as

Graft RejectionGraft SurvivalAntibodies, Monoclonal, HumanizedBiopsyHumansKidneyMulticenter Studies as TopicObservational Studies as TopicProspective StudiesAntibodies, Monoclonal, HumanizedLerdelimumabNephrologyRenal transplantationTRANSPLANT MEDICINETransplant pathology

Identifiers

PMID35450886
PMCPMC9024278

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.