Clinical trial NCT02675686: Amniotic Biomarkers for the Prediction of Postpartum Renal Function.
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nephropathy
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2016-02-05
Enrollment: 358
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population will be selected from 31 Multidisciplinary Prenatal Diagnosis Centers

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Renal function (according to Schwartz formula)
timeFrame: month 24
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: Hopital Nord
city: Angers
country: France
facility: Chu D Angers
city: Besancon
country: France
facility: Hopital Saint Jacques
city: Bordeaux
country: France
facility: Hopital Pellegrin
city: Brest
country: France
facility: Hopital Morvan
city: Bron
country: France
facility: Hopital Femme-Mere-Enfant
city: Cergy Pontoise
country: France
facility: Ch Rene Dubos Pontoise
city: Clamart
country: France
facility: Hopital Antoine Beclere (Ap Hp)
city: Clermont Ferrand
country: France
facility: Chu Estaing
city: Dijon
country: France
facility: Hopital Du Bocage
city: Grenoble
country: France
facility: Chu Grenoble
city: Lille
country: France
facility: Hopital Jeanne de Flandre
city: Limoges
country: France
facility: Chu Dupuytren
city: Marseille
country: France
facility: Hopital de La Timone (Ap Hm)
city: Montpellier
country: France
facility: Hopital Arnaud de Villeneuve
city: Nancy
country: France
facility: Hopital D'Enfants de Brabois
city: Nantes
country: France
facility: Chu de Nantes
city: Nice
country: France
facility: Hopital Lenval
city: Nimes
country: France
facility: Centre Hospitalier CAREMEAU
city: Paris
country: France
facility: Hopital Robert Debre
city: Paris
country: France
facility: Hopital Armand Trousseau (Ap-Hp)
city: Paris
country: France
facility: Hopital Necker Enfants Malades (Ap Hp)
city: Poitiers
country: France
facility: CHRU De POITIERS LA MILETRIE
city: Reims
country: France
facility: Hopital Maison Blanche
city: Rennes
country: France
facility: Hopital Sud
city: Rouen
country: France
facility: Hopital Charles Nicole
city: St-priest-en-jarez
country: France
facility: Hopital Nord
city: Strasbourg
country: France
facility: Hopital de Hautepierre
city: Talence
country: France
facility: Maison de Sante Protestante de Bagatelle/Bordeaux
city: Toulouse
country: France
facility: Chu Purpan
city: Tours
country: France
facility: Hopital Bretonneau
Study officials:
affiliation: Néphrologie pédiatrique - Hôpital des enfants
name: Stéphane. DECRAMER, MD; PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Klein J, Buffin-Meyer B, Boizard F, Moussaoui N, Lescat O, Breuil B, Fedou C, Feuillet G, Casemayou A, Neau E, Hindryckx A, Decatte L, Levtchenko E, Raaijmakers A, Vayssiere C, Goua V, Lucas C, Perrotin F, Cloarec S, Benachi A, Manca-Pellissier MC, Delmas HL, Bessenay L, Le Vaillant C, Allain-Launay E, Gondry J, Boudailliez B, Simon E, Prieur F, Lavocat MP, Saliou AH, De Parscau L, Bidat L, Noel C, Floch C, Bourdat-Michel G, Favre R, Weingertner AS, Oury JF, Baudouin V, Bory JP, Pietrement C, Fiorenza M, Massardier J, Kessler S, Lounis N, Auriol FC, Marcorelles P, Collardeau-Frachon S, Zurbig P, Mischak H, Magalhaes P, Batut J, Blader P, Saulnier Blache JS, Bascands JL, Schaefer F, Decramer S, Schanstra JP; BIOMAN consortium. Amniotic fluid peptides predict postnatal kidney survival in developmental kidney disease. Kidney Int. 2021 Mar;99(3):737-749. doi: 10.1016/j.kint.2020.06.043. Epub 2020 Aug 1.