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
BMC Nephrology, vol. 22, pp. 416
Abstract
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).
Authors 34
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Wai H. Lim corresponding
The University of Western Australia · Sir Charles Gairdner Hospital
Affiliation as printed
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
Department of Renal Medicine, Sir Charles Gairdner Hospital, Perth, Western Australia, 6009, Australia
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Queen Fabiola Children's University Hospital
Affiliation as printed
Department of Pediatric Nephrology, Hôpital Universitaire des Enfants-Reine Fabiola, Brussels, Belgium
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The University of Sydney · Children's Hospital at Westmead · Westmead Hospital
Affiliation as printed
Department of Nephrology, Westmead Children's Hospital, Sydney, Australia
Faculty of Medicine and Health, University of Sydney, Sydney, Australia
Department of Nephrology, Westmead Children’s Hospital, Sydney, Australia
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Emma Kinderziekenhuis · Amsterdam University Medical Centers
Affiliation as printed
Department of Pediatric Nephrology, Emma Children's Hospital, Amsterdam University Medical Center, Amsterdam, The Netherlands
Department of Pediatric Nephrology, Emma Children’s Hospital, Amsterdam University Medical Center, Amsterdam, The Netherlands
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Leiden University · Leiden University Medical Center
Affiliation as printed
Department of Immunology, Leiden University Medical Centre, Leiden, The Netherlands
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University of Auckland · Auckland City Hospital · Auckland District Health Board
Affiliation as printed
Department of Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand
Department of Renal Medicine, Auckland District Health Board, Auckland City Hospital, Auckland, New Zealand
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Radboud University Nijmegen · Radboud University Medical Center · Amalia Kinderziekenhuis
Affiliation as printed
Department of Pediatric Nephrology, Radboud University Medical Center, Amalia Children's Hospital, Nijmegen, The Netherlands
Department of Pediatric Nephrology, Radboud University Medical Center, Amalia Children’s Hospital, Nijmegen, The Netherlands
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Affiliation as printed
New Zealand Transplantation and Immunogenetics Laboratory, New Zealand Blood Service, Auckland, New Zealand
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Affiliation as printed
Erasmus Medical Center, Rotterdam, The Netherlands
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The University of Western Australia · Fiona Stanley Hospital · Westmead Hospital
Affiliation as printed
Department of Clinical Immunology, Fiona Stanley Hospital, Perth, Australia
Faculty of Health and Medical Sciences, Pathology & Laboratory Medicine, University of Western Australia, Perth, Australia
National Pancreas Unit, Westmead Hospital, Sydney, Australia
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The University of Queensland · Children's Health Queensland Hospital and Health Service
Affiliation as printed
Child and Adolescent Renal Service, Children's Health Queensland, Brisbane, Queensland, Australia
School of Medicine, University of Queensland, Brisbane, Queensland, Australia
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Leiden University · Leiden University Medical Center
Affiliation as printed
Department of Immunology, Leiden University Medical Centre, Leiden, The Netherlands
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Universitair Ziekenhuis Leuven
Affiliation as printed
Department of Pediatric Nephrology and Solid Organ Transplantation, University Hospitals Leuven, Leuven, Belgium
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Australian Red Cross Lifeblood
Affiliation as printed
Victoria Transplant and Immunogenetics Service, Australian Red Cross Blood Service, West Melbourne, Victoria, Australia
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Royal Children's Hospital · The University of Melbourne · Murdoch Children's Research Institute
Affiliation as printed
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
Department of Nephrology, Royal Children’s Hospital Melbourne, Parkville, Victoria, Australia
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The University of Sydney · Children's Hospital at Westmead · Westmead Hospital
Affiliation as printed
Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney, Australia
Sydney School of Public Health, The University of Sydney, Sydney, Australia
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Guy's Hospital · Nottingham University Hospitals NHS Trust · Great Ormond Street Hospital · Great Ormond Street Hospital for Children NHS Foundation Trust · Medical Research Council
Affiliation as printed
Department of Paediatric Nephrology, Great Ormond Street Hospital for Children NHS Foundation Trust, London, WC1N 3JH, UK
Department of Paediatric Nephrology, Nottingham University Hospital, Nottingham, UK
MRC Centre for Transplantation, Guy's Hospital, London, UK
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Children's Hospital at Westmead · Westmead Hospital
Affiliation as printed
Department of Nephrology, Westmead Children's Hospital, Sydney, Australia
Department of Nephrology, Westmead Children’s Hospital, Sydney, Australia
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Universitair Ziekenhuis Leuven · KU Leuven
Affiliation as printed
Department of Development and Regeneration (Woman and Child), KU Leuven, Leuven, Belgium
Department of Pediatric Nephrology and Solid Organ Transplantation, University Hospitals Leuven, Leuven, Belgium
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University of Cambridge · National Institute for Health and Care Research · Addenbrooke's Hospital · NIHR Cambridge Biomedical Research Centre
Affiliation as printed
Department of Surgery, University of Cambridge, Addenbrooke's Hospital, Hills Road, Cambridge, UK
NIHR Cambridge Biomedical Research Centre, Hills Road, Cambridge, UK
UK and NIHR Blood and Transplant Research Unit in Organ Donation and Transplantation, University of Cambridge, Hills Road, Cambridge, UK
Department of Surgery, University of Cambridge, Addenbrooke’s Hospital, Hills Road, Cambridge, UK
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Leiden University · Leiden University Medical Center
Affiliation as printed
Department of Immunology, Leiden University Medical Centre, Leiden, The Netherlands
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Universitair Ziekenhuis Leuven · KU Leuven
Affiliation as printed
Department of Microbiology and Immunology, KU Leuven, University of Leuven, Leuven, Belgium
Department of Nephrology and Renal Transplantation, University Hospitals Leuven, Leuven, Belgium
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The University of Western Australia · Princess Margaret Hospital for Children · Children's Hospital at Westmead · Westmead Hospital · Perth Children's Hospital
Affiliation as printed
Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney, Australia
Department of Nephrology, Perth Children's Hospital, Perth, Australia
Medical School, University of Western Australia, Perth, Australia
Centre for Kidney Research, The Children’s Hospital at Westmead, Westmead, Sydney, Australia
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Affiliation as printed
University of Otago Christchurch, Christchurch, New Zealand
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Affiliation as printed
Starship Children's Hospital, Auckland Health Board, Auckland, New Zealand
Starship Children’s Hospital, Auckland Health Board, Auckland, New Zealand
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Affiliation as printed
Department of Pediatric Nephrology and Rheumatology, Ghent University Hospital, Ghent, Belgium
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Children's Hospital at Westmead · Westmead Hospital
Affiliation as printed
Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney, Australia
Department of Renal Medicine, Westmead Hospital, Sydney, Australia
Centre for Kidney Research, The Children’s Hospital at Westmead, Westmead, Sydney, Australia
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Westmead Hospital · NSW Health Pathology
Affiliation as printed
NSW Health Pathology, Institute of Clinical Pathology and Medical Research, Westmead Hospital, Westmead, Sydney, Australia
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Children's Hospital at Westmead · Westmead Hospital
Affiliation as printed
Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney, Australia
Centre for Kidney Research, The Children’s Hospital at Westmead, Westmead, Sydney, Australia
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Affiliation as printed
Sydney School of Public Health, The University of Sydney, Sydney, Australia
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The University of Queensland · Children's Health Queensland Hospital and Health Service
Affiliation as printed
Child and Adolescent Renal Service, Children's Health Queensland, Brisbane, Queensland, Australia
School of Medicine, University of Queensland, Brisbane, Queensland, Australia
Child and Adolescent Renal Service, Children’s Health Queensland, Brisbane, Queensland, Australia
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The University of Western Australia · Princess Margaret Hospital for Children · Perth Children's Hospital · The University of Notre Dame Australia
Affiliation as printed
Department of Nephrology, Perth Children's Hospital, Perth, Australia
Medical School, University of Western Australia, Perth, Australia
School of Medicine, University of Notre Dame (Fremantle), Perth, Australia
Department of Nephrology, Perth Children’s Hospital, Perth, Australia
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The University of Western Australia · Queen Elizabeth II Medical Centre
Affiliation as printed
Anatomical Pathology, PathWest, QEII Medical Centre, Perth, Australia
Medical School, University of Western Australia, Perth, Australia
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The University of Sydney · Children's Hospital at Westmead · Westmead Hospital
Affiliation as printed
Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney, Australia
Department of Renal Medicine, Westmead Hospital, Sydney, Australia
Sydney School of Public Health, The University of Sydney, Sydney, Australia
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