PMID- 34923958 OWN - NLM STAT- MEDLINE DCOM- 20220310 LR - 20220310 IS - 1471-2369 (Electronic) IS - 1471-2369 (Linking) VI - 22 IP - 1 DP - 2021 Dec 19 TI - 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. PG - 416 LID - 10.1186/s12882-021-02619-0 [doi] LID - 416 AB - 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 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). CI - (c) 2021. The Author(s). FAU - Lim, Wai H AU - Lim WH AUID- ORCID: 0000-0002-3410-3572 AD - Department of Renal Medicine, Sir Charles Gairdner Hospital, Perth, Western Australia, 6009, Australia. wai.lim@health.wa.gov.au. AD - Medical School, University of Western Australia, Perth, Australia. wai.lim@health.wa.gov.au. FAU - Adams, Brigitte AU - Adams B AD - Department of Pediatric Nephrology, Hopital Universitaire des Enfants-Reine Fabiola, Brussels, Belgium. FAU - Alexander, Stephen AU - Alexander S AD - Department of Nephrology, Westmead Children's Hospital, Sydney, Australia. AD - Faculty of Medicine and Health, University of Sydney, Sydney, Australia. FAU - Bouts, Antonia H M AU - Bouts AHM AD - Department of Pediatric Nephrology, Emma Children's Hospital, Amsterdam University Medical Center, Amsterdam, The Netherlands. FAU - Claas, Frans AU - Claas F AD - Department of Immunology, Leiden University Medical Centre, Leiden, The Netherlands. FAU - Collins, Michael AU - Collins M AD - Department of Renal Medicine, Auckland District Health Board, Auckland City Hospital, Auckland, New Zealand. AD - Department of Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand. FAU - Cornelissen, Elisabeth AU - Cornelissen E AD - Department of Pediatric Nephrology, Radboud University Medical Center, Amalia Children's Hospital, Nijmegen, The Netherlands. FAU - Dunckley, Heather AU - Dunckley H AD - New Zealand Transplantation and Immunogenetics Laboratory, New Zealand Blood Service, Auckland, New Zealand. FAU - de Jong, Huib AU - de Jong H AD - Erasmus Medical Center, Rotterdam, The Netherlands. FAU - D'Orsogna, Lloyd AU - D'Orsogna L AD - Faculty of Health and Medical Sciences, Pathology & Laboratory Medicine, University of Western Australia, Perth, Australia. AD - Department of Clinical Immunology, Fiona Stanley Hospital, Perth, Australia. AD - National Pancreas Unit, Westmead Hospital, Sydney, Australia. FAU - Francis, Anna AU - Francis A AD - School of Medicine, University of Queensland, Brisbane, Queensland, Australia. AD - Child and Adolescent Renal Service, Children's Health Queensland, Brisbane, Queensland, Australia. FAU - Heidt, Sebastiaan AU - Heidt S AD - Department of Immunology, Leiden University Medical Centre, Leiden, The Netherlands. FAU - Herman, Jean AU - Herman J AD - Department of Pediatric Nephrology and Solid Organ Transplantation, University Hospitals Leuven, Leuven, Belgium. FAU - Holdsworth, Rhonda AU - Holdsworth R AD - Victoria Transplant and Immunogenetics Service, Australian Red Cross Blood Service, West Melbourne, Victoria, Australia. FAU - Kausman, Joshua AU - Kausman J AD - Department of Nephrology, Royal Children's Hospital Melbourne, Parkville, Victoria, Australia. AD - Murdoch Children's Research Institute, Melbourne, Victoria, Australia. AD - University of Melbourne, Melbourne, Victoria, Australia. FAU - Khalid, Rabia AU - Khalid R AD - Sydney School of Public Health, The University of Sydney, Sydney, Australia. AD - Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney, Australia. FAU - Kim, Jon Jin AU - Kim JJ AD - Department of Paediatric Nephrology, Nottingham University Hospital, Nottingham, UK. AD - Department of Paediatric Nephrology, Great Ormond Street Hospital for Children NHS Foundation Trust, London, WC1N 3JH, UK. AD - MRC Centre for Transplantation, Guy's Hospital, London, UK. FAU - Kim, Siah AU - Kim S AD - Department of Nephrology, Westmead Children's Hospital, Sydney, Australia. FAU - Knops, Noel AU - Knops N AD - Department of Pediatric Nephrology and Solid Organ Transplantation, University Hospitals Leuven, Leuven, Belgium. AD - Department of Development and Regeneration (Woman and Child), KU Leuven, Leuven, Belgium. FAU - Kosmoliaptsis, Vasilis AU - Kosmoliaptsis V AD - Department of Surgery, University of Cambridge, Addenbrooke's Hospital, Hills Road, Cambridge, UK. AD - UK and NIHR Blood and Transplant Research Unit in Organ Donation and Transplantation, University of Cambridge, Hills Road, Cambridge, UK. AD - NIHR Cambridge Biomedical Research Centre, Hills Road, Cambridge, UK. FAU - Kramer, Cynthia AU - Kramer C AD - Department of Immunology, Leiden University Medical Centre, Leiden, The Netherlands. FAU - Kuypers, Dirk AU - Kuypers D AD - Department of Nephrology and Renal Transplantation, University Hospitals Leuven, Leuven, Belgium. AD - Department of Microbiology and Immunology, KU Leuven, University of Leuven, Leuven, Belgium. FAU - Larkins, Nicholas AU - Larkins N AD - Medical School, University of Western Australia, Perth, Australia. AD - Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney, Australia. AD - Department of Nephrology, Perth Children's Hospital, Perth, Australia. FAU - Palmer, Suetonia C AU - Palmer SC AD - University of Otago Christchurch, Christchurch, New Zealand. FAU - Prestidge, Chanel AU - Prestidge C AD - Starship Children's Hospital, Auckland Health Board, Auckland, New Zealand. FAU - Prytula, Agnieszka AU - Prytula A AD - Department of Pediatric Nephrology and Rheumatology, Ghent University Hospital, Ghent, Belgium. FAU - Sharma, Ankit AU - Sharma A AD - Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney, Australia. AD - Department of Renal Medicine, Westmead Hospital, Sydney, Australia. FAU - Shingde, Meena AU - Shingde M AD - NSW Health Pathology, Institute of Clinical Pathology and Medical Research, Westmead Hospital, Westmead, Sydney, Australia. FAU - Taverniti, Anne AU - Taverniti A AD - Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney, Australia. FAU - Teixeira-Pinto, Armando AU - Teixeira-Pinto A AD - Sydney School of Public Health, The University of Sydney, Sydney, Australia. FAU - Trnka, Peter AU - Trnka P AD - School of Medicine, University of Queensland, Brisbane, Queensland, Australia. AD - Child and Adolescent Renal Service, Children's Health Queensland, Brisbane, Queensland, Australia. FAU - Willis, Francis AU - Willis F AD - Medical School, University of Western Australia, Perth, Australia. AD - Department of Nephrology, Perth Children's Hospital, Perth, Australia. AD - School of Medicine, University of Notre Dame (Fremantle), Perth, Australia. FAU - Wong, Daniel AU - Wong D AD - Medical School, University of Western Australia, Perth, Australia. AD - Anatomical Pathology, PathWest, QEII Medical Centre, Perth, Australia. FAU - Wong, Germaine AU - Wong G AD - Sydney School of Public Health, The University of Sydney, Sydney, Australia. AD - Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney, Australia. AD - Department of Renal Medicine, Westmead Hospital, Sydney, Australia. LA - eng PT - Clinical Trial Protocol PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20211219 PL - England TA - BMC Nephrol JT - BMC nephrology JID - 100967793 SB - IM MH - Adolescent MH - Child MH - *Donor Selection MH - *Histocompatibility MH - Humans MH - *Kidney Transplantation MH - *Patient Selection MH - Risk Assessment MH - Treatment Outcome PMC - PMC8684542 OTO - NOTNLM OT - Adolescents OT - Allograft loss OT - Antibody OT - Children OT - Human leukocyte antigen OT - Immunological profile OT - Kidney transplant OT - Parental donor OT - Rejection COIS- The authors declare that they have no competing interests. EDAT- 2021/12/21 06:00 MHDA- 2022/03/11 06:00 PMCR- 2021/12/19 CRDT- 2021/12/20 05:31 PHST- 2021/09/22 00:00 [received] PHST- 2021/11/23 00:00 [accepted] PHST- 2021/12/20 05:31 [entrez] PHST- 2021/12/21 06:00 [pubmed] PHST- 2022/03/11 06:00 [medline] PHST- 2021/12/19 00:00 [pmc-release] AID - 10.1186/s12882-021-02619-0 [pii] AID - 2619 [pii] AID - 10.1186/s12882-021-02619-0 [doi] PST - epublish SO - BMC Nephrol. 2021 Dec 19;22(1):416. doi: 10.1186/s12882-021-02619-0.