The ANTENATAL multicentre study to predict postnatal renal outcome in fetuses with posterior urethral valves: objectives and design.
development
kidney disease
obstructive uropathy
prediction
prenatal biomarkers
Journal
Clinical kidney journal
ISSN: 2048-8505
Titre abrégé: Clin Kidney J
Pays: England
ID NLM: 101579321
Informations de publication
Date de publication:
Jun 2020
Jun 2020
Historique:
received:
09
07
2019
accepted:
18
07
2019
entrez:
24
7
2020
pubmed:
24
7
2020
medline:
24
7
2020
Statut:
epublish
Résumé
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 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. 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. Accurate risk assessment in the prenatal period should strongly improve the management of fetuses with PUV.
Sections du résumé
BACKGROUND
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
METHODS
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
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
CONCLUSIONS
Accurate risk assessment in the prenatal period should strongly improve the management of fetuses with PUV.
Identifiants
pubmed: 32699617
doi: 10.1093/ckj/sfz107
pii: sfz107
pmc: PMC7367108
doi:
Types de publication
Journal Article
Langues
eng
Pagination
371-379Investigateurs
An Hindryckx
(A)
Luc De Catte
(L)
Christophe Vayssieres
(C)
Agnès Sartor
(A)
Marion Groussolles
(M)
Christelle Plard
(C)
Paul Guerby
(P)
Laure Connan
(L)
Mathieu Morin
(M)
Elizabeth Simon
(E)
Jean Breaud
(J)
Anne-Hélène Saliou
(AH)
Loic De Parscau
(L)
Nadine Jay
(N)
Isabelle Germouty
(I)
Gwenaelle Le Bouar
(G)
Amelie Ryckewaert
(A)
Marie-Christine Manca-Pellissier
(MC)
Thierry Merrot
(T)
Helene Laurichesse
(H)
Denis Gallot
(D)
Lucie Bessenay
(L)
Laurent Bidat
(L)
Philippe Boize
(P)
Norbert Winer
(N)
Emma Allain-Launey
(E)
Claudine Le Vaillant
(C)
Fabienne Prieur
(F)
Marie-Pierre Lavocat
(MP)
Frederic Coatleven
(F)
Eric Debromez
(E)
Jérôme Harembat
(J)
Brigitte Llanas
(B)
Romain Favre
(R)
Raphael Moog
(R)
Ariane Zaloszyc
(A)
Jérôme Massardier
(J)
Delphine Demede
(D)
Franck Perrotin
(F)
Sylvie Cloarec
(S)
Valérie Vequeau-Goua
(V)
Emmanuelle Descombes
(E)
Pierre Boulot
(P)
Denis Morin
(D)
Florent Fuchs
(F)
Julie Tenenbaum
(J)
Yves Ville
(Y)
Thomas Blanc
(T)
Laurence Heidet
(L)
Anne Paris
(A)
Eric Dobremez
(E)
Marie-Françoise Froute
(MF)
Jean Gondry
(J)
Charles Muszynski
(C)
Elodie Haraux
(E)
Fabienne Lobelle
(F)
Julien Chevreau
(J)
Jonathan Rosenblatt
(J)
Véronique Baudoin
(V)
Georges Deschenes
(G)
Virginie Guigue
(V)
Florence Amblard
(F)
Guylhène Bourdat-Michel
(G)
Elke Wühl
(E)
Franz Schaefer
(F)
Michael Elsässer
(M)
Nicola Persico
(N)
Federica Rossi
(F)
Gianantonio Manzoni
(G)
Erika A De Marco
(EA)
Giovanni Montini
(G)
Valentina Capone
(V)
Leonardo Caforio
(L)
Antonio Zaccara
(A)
Michele Innocenzi
(M)
Pietro Bagolan
(P)
Nicola Capozza
(N)
Marco Castagnetti
(M)
Mariangela Mancini
(M)
Dick Oepkes
(D)
Phebe Adama van Scheltema
(PA)
Wout Feitz
(W)
Barbara Kortmann
(B)
Michiel Schreuder
(M)
Marcin Tkaczyk
(M)
Małgorzata Stańczyk
(M)
Krzysztof Szaflik
(K)
Justyna Wojtera
(J)
Waldemar Krzeszowski
(W)
Tomasz Talar
(T)
Barbara Pawłowska
(B)
Katarzyna Fortecka-Piestrzeniewicz
(K)
Dariusz Olejniczak
(D)
Gema Ariceta
(G)
Silvia Arevalo
(S)
Carlota Rodo
(C)
Magdalena Fossum
(M)
Peter Lindgren
(P)
Paloma Parvex
(P)
Hassib Chehade
(H)
Informations de copyright
© The Author(s) 2019. Published by Oxford University Press on behalf of ERA-EDTA.
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