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

Clinical Kidney Journal
Bénédicte Buffin-MeyerANTENATAL Consortium

Abstract

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. 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 spe...Continue Reading

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Citations

Nov 9, 2019·Pediatric Nephrology : Journal of the International Pediatric Nephrology Association·Bénédicte Buffin-MeyerJoost P Schanstra
Jul 28, 2020·Proteomics. Clinical Applications·Agnieszka LatosinskaJoost P Schanstra

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Clinical Trials Mentioned

NCT03116217
NCT02675686

Software Mentioned

ANTENATAL

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