Amniotic Biomarkers for the Prediction of Postpartum Renal Function.

Nephropathy Clinical Trial

— BIOMAN  

Official title:

Amniotic Fluid Biomarker Research for Prediction of Postnatal Renal Function in Fetus With a Bilateral Abnormal Renal Development: National, Multicenter, Prospective and Non-interventional Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02675686
• Other study ID #: 10 138 01
• Secondary ID: 2010-A01151-38
• Status: Completed
• Start date: December 2010
• Est. completion date: December 2016

Study information

• Verified date: June 2018
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The discovery of antenatal bilateral renal anomaly poses an essential question: can we predict postnatal renal function? Ultrasound is insufficiently precise to predict postnatal renal function evolution.

The objective of this study is to estimate the specificity and sensitivity of amniotic fluid biomarkers to predict postnatal renal function in fetuses with bilateral developmental nephropathies.

Both fetuses with bilateral renal anomalies and control (healthy) fetuses will be included.

For this study amniotic fluid will only be collected according to routine clinical practice and only excess amniotic fluid sample will be used for the study.

The potentially identified biomarkers will not change routine management of the pregnancies in the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 358
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Nephropathy

Locations

Country	Name	City	State
France	Hopital Nord	Amiens
France	Chu D Angers	Angers
France	Hopital Saint Jacques	Besancon
France	Hopital Pellegrin	Bordeaux
France	Hopital Morvan	Brest
France	Hopital Femme-Mere-Enfant	Bron
France	Ch Rene Dubos Pontoise	Cergy Pontoise
France	Hopital Antoine Beclere (Ap Hp)	Clamart
France	Chu Estaing	Clermont Ferrand
France	Hopital Du Bocage	Dijon
France	Chu Grenoble	Grenoble
France	Hopital Jeanne de Flandre	Lille
France	Chu Dupuytren	Limoges
France	Hopital de La Timone (Ap Hm)	Marseille
France	Hopital Arnaud de Villeneuve	Montpellier
France	Hopital D'Enfants de Brabois	Nancy
France	Chu de Nantes	Nantes
France	Hopital Lenval	Nice
France	Centre Hospitalier CAREMEAU	Nimes
France	Hopital Armand Trousseau (Ap-Hp)	Paris
France	Hopital Necker Enfants Malades (Ap Hp)	Paris
France	Hopital Robert Debre	Paris
France	CHRU De POITIERS LA MILETRIE	Poitiers
France	Hopital Maison Blanche	Reims
France	Hopital Sud	Rennes
France	Hopital Charles Nicole	Rouen
France	Hopital Nord	St-priest-en-jarez
France	Hopital de Hautepierre	Strasbourg
France	Maison de Sante Protestante de Bagatelle/Bordeaux	Talence
France	Chu Purpan	Toulouse
France	Hopital Bretonneau	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Renal function (according to Schwartz formula)	Renal function (according to Schwartz formula)	month 24