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The ANTENATAL multicentre study to predict postnatal renal outcome in fetuses with posterior urethral valves: objectives and design

Authors
  • Buffin-Meyer, Bénédicte1, 2
  • Klein, Julie1, 2
  • van der Zanden, Loes F M3
  • Levtchenko, Elena4
  • Moulos, Panogiotis5
  • Lounis, Nadia6
  • Conte-Auriol, Françoise6
  • Hindryckx, An7
  • Wühl, Elke8
  • Persico, Nicola9, 10
  • Oepkes, Dick11
  • Schreuder, Michiel F12
  • Tkaczyk, Marcin13
  • Ariceta, Gema14
  • Fossum, Magdalena15
  • Parvex, Paloma16
  • Feitz, Wout17
  • Olsen, Henning18
  • Montini, Giovanni19
  • Decramer, Stéphane1, 2, 20, 21
  • And 1 more
  • 1 Institut National de la Santé et de la Recherche Médicale (INSERM), U1048, Institut of Cardiovascular and Metabolic Disease
  • 2 Université Toulouse III Paul-Sabatier
  • 3 Department for Health Evidence, Radboud Institute for Health Sciences, Radboud University Medical Center
  • 4 Department of Development & Regeneration
  • 5 HybridStat Predictive Analytics
  • 6 Unité de Recherche Clinique Pédiatrique, Module Plurithématique Pédiatrique du Centre D'Investigation Clinique Toulouse 1436
  • 7 Department of Obstetrics and Gynaecology, University Hospitals Leuven
  • 8 Division of Pediatric Nephrology, Center for Pediatrics and Adolescent Medicine, University Hospital Heidelberg
  • 9 Department of Clinical Science and Community Health, University of Milan
  • 10 Sergio Bonelli Centre for the Prevention of Renal Failure from Fetal to Pediatric Age
  • 11 Department of Prenatal Diagnosis and Therapy, Leiden University Medical Center
  • 12 Department of Pediatric Nephrology, Radboudumc Amalia Children’s Hospital, Radboud Institute for Molecular Life Sciences
  • 13 Department of Pediatrics, Immunology and Nephrology, Polish Mother’s Memorial Hospital Research Institute
  • 14 Servei de Nefrologia Pediátrica Hospital, Universitario Vall d’Hebron, Universitat Autónoma de Barcelona
  • 15 Section of Pediatric Urology, Department of Highly Specialized Pediatric Surgery and Pediatric Medicine, Karolinska University Hospital and Department of Women’s and Children’s Health, Karolinska Institutet
  • 16 Pediatric Nephrology, Unité Romande de Néphrologie Pédiatrique, Hôpitaux Universitaire Genève (HUG)
  • 17 For ERN eUROGEN, Department of Urology, Radboudumc Amalia Children's Hospital, Radboud University Medical Center
  • 18 For ERN eUROGEN, Paediatric Urology, Department of Urology, Aarhus University Hospital & Aarhus University
  • 19 For ERN ERKNet, Pediatric Nephrology—Centro Sergio Bonelli for the Prevention and Treatment of Urinary Tract Malformations
  • 20 Service de Néphrologie Pédiatrique, Hôpital des Enfants
  • 21 Centre De Référence des Maladies Rénales Rares du Sud-Ouest (SORARE)
Type
Published Article
Journal
Clinical Kidney Journal
Publisher
Oxford University Press
Publication Date
Sep 26, 2019
Volume
13
Issue
3
Pages
371–379
Identifiers
DOI: 10.1093/ckj/sfz107
PMID: 32699617
PMCID: PMC7367108
Source
PubMed Central
Keywords
License
Unknown

Abstract

Background Posterior urethral valves (PUV) account for 17% of paediatric end-stage renal disease. A major issue in the management of PUV is prenatal prediction of postnatal renal function. Fetal ultrasound and fetal urine biochemistry are currently employed for this prediction, but clearly lack precision. We previously developed a fetal urine peptide signature that predicted in utero with high precision postnatal renal function in fetuses with PUV. We describe here the objectives and design of the prospective international multicentre ANTENATAL (multicentre validation of a fetal urine peptidome-based classifier to predict postnatal renal function in posterior urethral valves) study, set up to validate this fetal urine peptide signature. Methods Participants will be PUV pregnancies enrolled from 2017 to 2021 and followed up until 2023 in >30 European centres endorsed and supported by European reference networks for rare urological disorders (ERN eUROGEN) and rare kidney diseases (ERN ERKNet). The endpoint will be renal/patient survival at 2 years postnatally. Assuming α = 0.05, 1–β = 0.8 and a mean prevalence of severe renal outcome in PUV individuals of 0.35, 400 patients need to be enrolled to validate the previously reported sensitivity and specificity of the peptide signature. Results In this largest multicentre study of antenatally detected PUV, we anticipate bringing a novel tool to the clinic. Based on urinary peptides and potentially amended in the future with additional omics traits, this tool will be able to precisely quantify postnatal renal survival in PUV pregnancies. The main limitation of the employed approach is the need for specialized equipment. Conclusions Accurate risk assessment in the prenatal period should strongly improve the management of fetuses with PUV.

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