The ANTENATAL multicentre study to predict postnatal renal outcome in fetuses with posterior urethral valves: objectives and design
Author:
Buffin-Meyer Bénédicte12, Klein Julie12, van der Zanden Loes F M3, Levtchenko Elena4, Moulos Panogiotis5, Lounis Nadia6, Conte-Auriol Françoise6, Hindryckx An7, Wühl Elke8, Persico Nicola910, Oepkes Dick11, Schreuder Michiel F12ORCID, Tkaczyk Marcin13, Ariceta Gema14, Fossum Magdalena15, Parvex Paloma16, Feitz Wout17, Olsen Henning18, Montini Giovanni19, Decramer Stéphane122021, Schanstra Joost P12, Hindryckx An, De Catte Luc, Vayssieres Christophe, Sartor Agnès, Groussolles Marion, Plard Christelle, Guerby Paul, Connan Laure, Morin Mathieu, Simon Elizabeth, Breaud Jean, Saliou Anne-Hélène, De Parscau Loic, Jay Nadine, Germouty Isabelle, Le Bouar Gwenaelle, Ryckewaert Amelie, Manca-Pellissier Marie-Christine, Merrot Thierry, Laurichesse Helene, Gallot Denis, Bessenay Lucie, Bidat Laurent, Boize Philippe, Winer Norbert, Allain-Launey Emma, Le Vaillant Claudine, Prieur Fabienne, Lavocat Marie-Pierre, Coatleven Frederic, Debromez Eric, Harembat Jérôme, Llanas Brigitte, Favre Romain, Moog Raphael, Zaloszyc Ariane, Massardier Jérôme, Demede Delphine, Perrotin Franck, Cloarec Sylvie, Vequeau-Goua Valérie, Descombes Emmanuelle, Boulot Pierre, Morin Denis, Fuchs Florent, Tenenbaum Julie, Ville Yves, Blanc Thomas, Heidet Laurence, Paris Anne, Dobremez Eric, Froute Marie-Françoise, Gondry Jean, Muszynski Charles, Haraux Elodie, Lobelle Fabienne, Chevreau Julien, Rosenblatt Jonathan, Baudoin Véronique, Deschenes Georges, Guigue Virginie, Amblard Florence, Bourdat-Michel Guylhène, Wühl Elke, Schaefer Franz, Elsässer Michael, Persico Nicola, Rossi Federica, Manzoni Gianantonio, De Marco Erika A, Montini Giovanni, Capone Valentina, Caforio Leonardo, Zaccara Antonio, Innocenzi Michele, Bagolan Pietro, Capozza Nicola, Castagnetti Marco, Mancini Mariangela, Oepkes Dick, van Scheltema Phebe Adama, Feitz Wout, Kortmann Barbara, Schreuder Michiel, Tkaczyk Marcin, Stańczyk Małgorzata, Szaflik Krzysztof, Wojtera Justyna, Krzeszowski Waldemar, Talar Tomasz, Pawłowska Barbara, Fortecka-Piestrzeniewicz Katarzyna, Olejniczak Dariusz, Ariceta Gema, Arevalo Silvia, Rodo Carlota, Fossum Magdalena, Lindgren Peter, Parvex Paloma, Chehade Hassib,
Affiliation:
1. Institut National de la Santé et de la Recherche Médicale (INSERM), U1048, Institut of Cardiovascular and Metabolic Disease, Toulouse, France 2. Université Toulouse III Paul-Sabatier, Toulouse, France 3. Department for Health Evidence, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands 4. Department of Development & Regeneration, KU Leuven, Leuven, Belgium 5. HybridStat Predictive Analytics, Athens, Greece 6. Unité de Recherche Clinique Pédiatrique, Module Plurithématique Pédiatrique du Centre D'Investigation Clinique Toulouse 1436, Hôpital des Enfants, CHU Toulouse, Toulouse, France 7. Department of Obstetrics and Gynaecology, University Hospitals Leuven, Leuven, Belgium 8. Division of Pediatric Nephrology, Center for Pediatrics and Adolescent Medicine, University Hospital Heidelberg, Heidelberg, Germany 9. Department of Clinical Science and Community Health, University of Milan, Milan, Italy 10. Sergio Bonelli Centre for the Prevention of Renal Failure from Fetal to Pediatric Age, Fondazione Ca’ Granda Ospedale Maggiore Policlinico, Milan, Italy 11. Department of Prenatal Diagnosis and Therapy, Leiden University Medical Center, Leiden, The Netherlands 12. Department of Pediatric Nephrology, Radboudumc Amalia Children’s Hospital, Radboud Institute for Molecular Life Sciences, Nijmegen, The Netherlands 13. Department of Pediatrics, Immunology and Nephrology, Polish Mother’s Memorial Hospital Research Institute, Lodz, Poland 14. Servei de Nefrologia Pediátrica Hospital, Universitario Vall d’Hebron, Universitat Autónoma de Barcelona, Barcelona, Spain 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, Stockholm, Sweden 16. Pediatric Nephrology, Unité Romande de Néphrologie Pédiatrique, Hôpitaux Universitaire Genève (HUG), Genève, Switzerland 17. For ERN eUROGEN, Department of Urology, Radboudumc Amalia Children's Hospital, Radboud University Medical Center, Nijmegen, The Netherlands 18. For ERN eUROGEN, Paediatric Urology, Department of Urology, Aarhus University Hospital & Aarhus University, Aarhus, Denmark 19. For ERN ERKNet, Pediatric Nephrology—Centro Sergio Bonelli for the Prevention and Treatment of Urinary Tract Malformations, Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico, Milan, Italy 20. Service de Néphrologie Pédiatrique, Hôpital des Enfants, CHU Toulouse, Toulouse, France 21. Centre De Référence des Maladies Rénales Rares du Sud-Ouest (SORARE), Toulouse, France
Abstract
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.
Funder
Programme Hospitalier de Recherche Clinique La Foundation de la Recherche Médicale Polish Mothers Memorial Hospital Research Institute Dutch Kidney Foundation Netherlands Organisation for Scientific Research European Union
Publisher
Oxford University Press (OUP)
Subject
Transplantation,Nephrology
Cited by
22 articles.
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