Improve in-depth immunological risk assessment to optimize genetic-compatibility and clinical outcomes in child and adolescent recipients of parental donor kidney transplants: protocol for the INCEPTION study.

Adolescent Child Donor Selection Histocompatibility Humans Kidney Transplantation Patient Selection Risk Assessment Treatment Outcome
Adolescents Allograft loss Antibody Children Human leukocyte antigen Immunological profile Kidney transplant Parental donor Rejection

Journal

BMC nephrology
ISSN: 1471-2369
Titre abrégé: BMC Nephrol
Pays: England
ID NLM: 100967793

Informations de publication

Date de publication:
19 12 2021
Historique:
received: 22 09 2021
accepted: 23 11 2021
entrez: 20 12 2021
pubmed: 21 12 2021
medline: 11 3 2022
Statut: epublish

Résumé

Parental donor kidney transplantation is the most common treatment option for children and adolescents with kidney failure. Emerging data from observational studies have reported improved short- and medium-term allograft outcomes in recipients of paternal compared to maternal donors. The INCEPTION study aims to identify potential differences in immunological compatibility between maternal and paternal donor kidneys and ascertain how this affects kidney allograft outcomes in children and adolescents with kidney failure. This longitudinal observational study will recruit kidney transplant recipients aged ≤18 years who have received a parental donor kidney transplant across 4 countries (Australia, New Zealand, United Kingdom and the Netherlands) between 1990 and 2020. High resolution human leukocyte antigen (HLA) typing of both recipients and corresponding parental donors will be undertaken, to provide an in-depth assessment of immunological compatibility. The primary outcome is a composite of de novo donor-specific anti-HLA antibody (DSA), biopsy-proven acute rejection or allograft loss up to 60-months post-transplantation. Secondary outcomes are de novo DSA, biopsy-proven acute rejection, acute or chronic antibody mediated rejection or Chronic Allograft Damage Index (CADI) score of > 1 on allograft biopsy post-transplant, allograft function, proteinuria and allograft loss. Using principal component analysis and Cox proportional hazards regression modelling, we will determine the associations between defined sets of immunological and clinical parameters that may identify risk stratification for the primary and secondary outcome measures among young people accepting a parental donor kidney for transplantation. This study design will allow us to specifically investigate the relative importance of accepting a maternal compared to paternal donor, for families deciding on the best option for donation. The INCEPTION study findings will explore potentially differential immunological risks of maternal and paternal donor kidneys for transplantation among children and adolescents. Our study will provide the evidence base underpinning the selection of parental donor in order to achieve the best projected long-term kidney transplant and overall health outcomes for children and adolescents, a recognized vulnerable population. The INCEPTION study has been registered with the Australian New Zealand Clinical Trials Registry, with the trial registration number of ACTRN12620000911998 (14th September 2020).

Sections du résumé

BACKGROUND
Parental donor kidney transplantation is the most common treatment option for children and adolescents with kidney failure. Emerging data from observational studies have reported improved short- and medium-term allograft outcomes in recipients of paternal compared to maternal donors. The INCEPTION study aims to identify potential differences in immunological compatibility between maternal and paternal donor kidneys and ascertain how this affects kidney allograft outcomes in children and adolescents with kidney failure.
METHODS
This longitudinal observational study will recruit kidney transplant recipients aged ≤18 years who have received a parental donor kidney transplant across 4 countries (Australia, New Zealand, United Kingdom and the Netherlands) between 1990 and 2020. High resolution human leukocyte antigen (HLA) typing of both recipients and corresponding parental donors will be undertaken, to provide an in-depth assessment of immunological compatibility. The primary outcome is a composite of de novo donor-specific anti-HLA antibody (DSA), biopsy-proven acute rejection or allograft loss up to 60-months post-transplantation. Secondary outcomes are de novo DSA, biopsy-proven acute rejection, acute or chronic antibody mediated rejection or Chronic Allograft Damage Index (CADI) score of > 1 on allograft biopsy post-transplant, allograft function, proteinuria and allograft loss. Using principal component analysis and Cox proportional hazards regression modelling, we will determine the associations between defined sets of immunological and clinical parameters that may identify risk stratification for the primary and secondary outcome measures among young people accepting a parental donor kidney for transplantation. This study design will allow us to specifically investigate the relative importance of accepting a maternal compared to paternal donor, for families deciding on the best option for donation.
DISCUSSION
The INCEPTION study findings will explore potentially differential immunological risks of maternal and paternal donor kidneys for transplantation among children and adolescents. Our study will provide the evidence base underpinning the selection of parental donor in order to achieve the best projected long-term kidney transplant and overall health outcomes for children and adolescents, a recognized vulnerable population.
TRIAL REGISTRATION
The INCEPTION study has been registered with the Australian New Zealand Clinical Trials Registry, with the trial registration number of ACTRN12620000911998 (14th September 2020).

Identifiants

DOI: 10.1186/s12882-021-02619-0 PMID: 34923958 PMC: PMC8684542
pubmed: 34923958
doi: 10.1186/s12882-021-02619-0
pii: 10.1186/s12882-021-02619-0
pmc: PMC8684542
doi:

Types de publication

Clinical Trial Protocol Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

416

Informations de copyright

© 2021. The Author(s).

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Auteurs

Wai H Lim (WH)

Department of Renal Medicine, Sir Charles Gairdner Hospital, Perth, Western Australia, 6009, Australia. wai.lim@health.wa.gov.au.
Medical School, University of Western Australia, Perth, Australia. wai.lim@health.wa.gov.au.
ORCID: 0000-0002-3410-3572

Brigitte Adams (B)

Department of Pediatric Nephrology, Hôpital Universitaire des Enfants-Reine Fabiola, Brussels, Belgium.

Stephen Alexander (S)

Department of Nephrology, Westmead Children's Hospital, Sydney, Australia.
Faculty of Medicine and Health, University of Sydney, Sydney, Australia.

Antonia H M Bouts (AHM)

Department of Pediatric Nephrology, Emma Children's Hospital, Amsterdam University Medical Center, Amsterdam, The Netherlands.

Frans Claas (F)

Department of Immunology, Leiden University Medical Centre, Leiden, The Netherlands.

Michael Collins (M)

Department of Renal Medicine, Auckland District Health Board, Auckland City Hospital, Auckland, New Zealand.
Department of Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.

Elisabeth Cornelissen (E)

Department of Pediatric Nephrology, Radboud University Medical Center, Amalia Children's Hospital, Nijmegen, The Netherlands.

Heather Dunckley (H)

New Zealand Transplantation and Immunogenetics Laboratory, New Zealand Blood Service, Auckland, New Zealand.

Huib de Jong (H)

Erasmus Medical Center, Rotterdam, The Netherlands.

Lloyd D'Orsogna (L)

Faculty of Health and Medical Sciences, Pathology & Laboratory Medicine, University of Western Australia, Perth, Australia.
Department of Clinical Immunology, Fiona Stanley Hospital, Perth, Australia.
National Pancreas Unit, Westmead Hospital, Sydney, Australia.

Anna Francis (A)

School of Medicine, University of Queensland, Brisbane, Queensland, Australia.
Child and Adolescent Renal Service, Children's Health Queensland, Brisbane, Queensland, Australia.

Sebastiaan Heidt (S)

Department of Immunology, Leiden University Medical Centre, Leiden, The Netherlands.

Jean Herman (J)

Department of Pediatric Nephrology and Solid Organ Transplantation, University Hospitals Leuven, Leuven, Belgium.

Rhonda Holdsworth (R)

Victoria Transplant and Immunogenetics Service, Australian Red Cross Blood Service, West Melbourne, Victoria, Australia.

Joshua Kausman (J)

Department of Nephrology, Royal Children's Hospital Melbourne, Parkville, Victoria, Australia.
Murdoch Children's Research Institute, Melbourne, Victoria, Australia.
University of Melbourne, Melbourne, Victoria, Australia.

Rabia Khalid (R)

Sydney School of Public Health, The University of Sydney, Sydney, Australia.
Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney, Australia.

Jon Jin Kim (JJ)

Department of Paediatric Nephrology, Nottingham University Hospital, Nottingham, UK.
Department of Paediatric Nephrology, Great Ormond Street Hospital for Children NHS Foundation Trust, London, WC1N 3JH, UK.
MRC Centre for Transplantation, Guy's Hospital, London, UK.

Siah Kim (S)

Department of Nephrology, Westmead Children's Hospital, Sydney, Australia.

Noël Knops (N)

Department of Pediatric Nephrology and Solid Organ Transplantation, University Hospitals Leuven, Leuven, Belgium.
Department of Development and Regeneration (Woman and Child), KU Leuven, Leuven, Belgium.

Vasilis Kosmoliaptsis (V)

Department of Surgery, University of Cambridge, Addenbrooke's Hospital, Hills Road, Cambridge, UK.
UK and NIHR Blood and Transplant Research Unit in Organ Donation and Transplantation, University of Cambridge, Hills Road, Cambridge, UK.
NIHR Cambridge Biomedical Research Centre, Hills Road, Cambridge, UK.

Cynthia Kramer (C)

Department of Immunology, Leiden University Medical Centre, Leiden, The Netherlands.

Dirk Kuypers (D)

Department of Nephrology and Renal Transplantation, University Hospitals Leuven, Leuven, Belgium.
Department of Microbiology and Immunology, KU Leuven, University of Leuven, Leuven, Belgium.

Nicholas Larkins (N)

Medical School, University of Western Australia, Perth, Australia.
Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney, Australia.
Department of Nephrology, Perth Children's Hospital, Perth, Australia.

Suetonia C Palmer (SC)

University of Otago Christchurch, Christchurch, New Zealand.

Chanel Prestidge (C)

Starship Children's Hospital, Auckland Health Board, Auckland, New Zealand.

Agnieszka Prytula (A)

Department of Pediatric Nephrology and Rheumatology, Ghent University Hospital, Ghent, Belgium.

Ankit Sharma (A)

Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney, Australia.
Department of Renal Medicine, Westmead Hospital, Sydney, Australia.

Meena Shingde (M)

NSW Health Pathology, Institute of Clinical Pathology and Medical Research, Westmead Hospital, Westmead, Sydney, Australia.

Anne Taverniti (A)

Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney, Australia.

Armando Teixeira-Pinto (A)

Sydney School of Public Health, The University of Sydney, Sydney, Australia.

Peter Trnka (P)

School of Medicine, University of Queensland, Brisbane, Queensland, Australia.
Child and Adolescent Renal Service, Children's Health Queensland, Brisbane, Queensland, Australia.

Francis Willis (F)

Medical School, University of Western Australia, Perth, Australia.
Department of Nephrology, Perth Children's Hospital, Perth, Australia.
School of Medicine, University of Notre Dame (Fremantle), Perth, Australia.

Daniel Wong (D)

Medical School, University of Western Australia, Perth, Australia.
Anatomical Pathology, PathWest, QEII Medical Centre, Perth, Australia.

Germaine Wong (G)

Sydney School of Public Health, The University of Sydney, Sydney, Australia.
Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney, Australia.
Department of Renal Medicine, Westmead Hospital, Sydney, Australia.

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Classifications MeSH

questionsmedicales.fr › Personnes › Tranches d'âge › Adolescent › Improve in-depth immunological risk assessment...
questionsmedicales.fr › Personnes › Tranches d'âge › Enfant › Improve in-depth immunological risk assessment...
questionsmedicales.fr › Établissements, main d'oeuvre et services de soins de santé › Services de santé › Acquisition d'organes et de tissus › Sélection de donneurs › Improve in-depth immunological risk assessment...
questionsmedicales.fr › Phénomènes du système immunitaire › Immunologie en transplantation › Histocompatibilité › Improve in-depth immunological risk assessment...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Improve in-depth immunological risk assessment...
questionsmedicales.fr › Procédures de chirurgie opératoire › Procédures de chirurgie urogénitale › Procédures de chirurgie urologique › Transplantation rénale › Improve in-depth immunological risk assessment...
questionsmedicales.fr › Administration des services de santé › Gestion des soins aux patients › Sélection de patients › Improve in-depth immunological risk assessment...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Statistiques comme sujet › Probabilité › Risque › Appréciation des risques › Improve in-depth immunological risk assessment...
questionsmedicales.fr › Qualité, accès, évaluation des soins de santé › Qualité des soins de santé › Mécanismes d'évaluation des soins de santé › Évaluation des résultats et des processus en soins de santé › Évaluation de résultat (soins) › Résultat thérapeutique › Improve in-depth immunological risk assessment...