This trial is active, not recruiting.

Condition nephropathy
Treatment amniocentesis
Sponsor University Hospital, Toulouse
Start date December 2010
End date December 2016
Trial size 358 participants
Trial identifier NCT02675686, 10 138 01, 2010-A01151-38


The discovery of antenatal bilateral renal anomaly poses an essential question: can we predict postnatal renal function in short, medium and long term? Ultrasound appears sufficient in severe or mild forms. In the "Intermediaries" form (normal size dysplastic kidneys with persistence of amniotic fluid), ultrasound and current markers do not predict postnatal renal function evolution.

The objective of this study is to estimate the specificity and sensitivity of amniotic biomarkers profile in the diagnosis of renal functionality in fetuses with bilateral nephropathy development.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
Primary purpose diagnostic
(Active Comparator)
amniotic fluid sample by amniocentesis of fetuses with renal abnormality
amniotic fluid sample by amniocentesis
(Sham Comparator)
amniotic fluid sample by amniocentesis of healthy fetuses
amniotic fluid sample by amniocentesis

Primary Outcomes

renal function (according to Schwartz formula)
time frame: month 24

Eligibility Criteria

Male or female participants of any age.

INCLUSION CRITERIA: All fetuses with a bilateral abnormal renal development (structure modification of the parenchyma with or without urinary tract abnormalities associated) The following sonographic criteria are used: - Fetal kidney size <2.5ep or <2 standard deviation (SD) defining renal hypoplasia or renal size> 97.5ep or> 2 SD defining nephromegaly - And / or hyperechogenicity (more echogenic than the liver kidney) - And / or cysts - And / or abnormal cortico-medullary differentiation (decrease or lack thereof) - And / or bilateral cortical thinning - And / or the possibility of an initial unilateral renal disease in the case of a pathology on which kidney damage is usually to become bilateral during evolution EXCLUSION CRITERIA: - Foetuses with severe malformations that can change the amniotic or urine proteome: complex heart disease, digestive stenosis, fetal immobility. - Fetus whose mother has chronic infectious diseases (HIV, hepatitis B and C) or acute infectious diseases such chorioamnionitis. - Parental Refusal.

Additional Information

Official title Amniotic Biomarkers Research for Prediction of Postnatal Renal Function in Fetus With a Bilateral Abnormal Renal Development: National, Multicenter, Prospective and Non-interventional Study of Diagnostic Validation.
Principal investigator Stéphane. DECRAMER, MD; PHD
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by University Hospital, Toulouse.