Research Project

Project Title:

ANTENATAL - Multicenter Validation of a Fetal urine Peptidome-based Classifier to Predict Post-Natal Renal Function in Posterior Urethral Valves

Project Type:

Translational research

Disease group(s):

Congenital malformations & ciliopathies

Project Summary:

Posterior urethral valves (PUV), although a rare disease (1 in 5000–8000 children), is the major cause of severe obstructive nephropathy in male children and accounts for 17% of paediatric end-stage renal disease (ESRD). Despite the severity of the disease and its impact on mortality and morbidity, the molecular basis of this condition is largely unknown.
The current clinical practice of predicting the severity of PUV pre-natally is based on pre-natal ultrasound and fetal urine biochemistry. However, as exemplified by the consortium partners and others, the tools currently used in the clinic are clearly insufficient to predict post-natal renal outcome with any accuracy in PUV patients. In the past this lack of efficient prognostic methods has led to many parents opting for termination of pregnancy and significantly hampered efficient stratification of patients that would potentially benefit from pre-natal intervention (vesico-amniotic shunting or laser ablation of valves).
In a proof-of concept study (Klein et al., Sci Transl Med. 2013), we were the first to identify a fetal urine peptidome-based classifier that predicts in utero with high sensitivity and specificity post-natal renal function in fetuses with PUV. This classifier significantly outperformed the routine ultrasound and fetal urine biochemistry. It is anticipated that scoring with this classifier will improve the stratification of patients that will benefit from intervention in PUV.
The aim of ANTENATAL is to validate the fetal urine based classifier in a multicentre context.

Lead principal investigator(s):

Stephane Decramer, Toulouse
Joost Schanstra, Toulouse

Co-investigator(s):

Giovanni Montini, Milan
Elena Levtchenko, Amsterdam
Gema Ariceta, Barcelona
,
Franz Schaefer, Heidelberg
Elke Wühl, Heidelberg
many Others, Europe

Project Period:

06/2017   -   08/2022

Sponsors:

Local resources

ClinicalTrials.gov:

NCT03116217

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