Amniotic Biomarkers for the Prediction of Postpartum Renal Function.

NCT02675686 | Completed

• 2 other identifiers: 10 138 012010-A01151-38
• Study Type: observational
• Target: 358
• Locations: 1 country
• Sites: 31

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.

Conditions

Nephropathy

Outcome Measures

Primary Outcomes (1)

• Renal function (according to Schwartz formula)

  Renal function (according to Schwartz formula)

  month 24

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The population will be selected from 31 Multidisciplinary Prenatal Diagnosis Centers

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (31)

Hopital Nord

Amiens, France

Location

Chu D Angers

Angers, 49933, France

Location

Hopital Saint Jacques

Besançon, 25030, France

Location

Hopital Pellegrin

Bordeaux, 33076, France

Location

Hopital Morvan

Brest, 29609, France

Location

Hopital Femme-Mere-Enfant

Bron, 69500, France

Location

Ch Rene Dubos Pontoise

Cergy-Pontoise, 95303, France

Location

Hopital Antoine Beclere (Ap Hp)

Clamart, 92141, France

Location

Chu Estaing

Clermont-Ferrand, 63003, France

Location

Hopital Du Bocage

Dijon, 21000, France

Location

Chu Grenoble

Grenoble, 38043, France

Location

Hopital Jeanne de Flandre

Lille, 59037, France

Location

Chu Dupuytren

Limoges, 87000, France

Location

Hopital de La Timone (Ap Hm)

Marseille, 13385, France

Location

Hopital Arnaud de Villeneuve

Montpellier, 34295, France

Location

Hopital D'Enfants de Brabois

Nancy, France

Location

Chu de Nantes

Nantes, 44093, France

Location

Hopital Lenval

Nice, 06200, France

Location

Centre Hospitalier CAREMEAU

Nîmes, 30029, France

Location

Hopital Robert Debre

Paris, 75019, France

Location

Hopital Armand Trousseau (Ap-Hp)

Paris, 75571, France

Location

Hopital Necker Enfants Malades (Ap Hp)

Paris, 75743, France

Location

CHRU De POITIERS LA MILETRIE

Poitiers, 86021, France

Location

Hopital Maison Blanche

Reims, 51092, France

Location

Hopital Sud

Rennes, 35203, France

Location

Hopital Charles Nicole

Rouen, 76031, France

Location

Hopital Nord

Saint-Priest-en-Jarez, 42277, France

Location

Hopital de Hautepierre

Strasbourg, 67098, France

Location

Maison de Sante Protestante de Bagatelle/Bordeaux

Talence, 33401, France

Location

Chu Purpan

Toulouse, 31059, France

Location

Hopital Bretonneau

Tours, 37000, France

Location

Related Publications (1)

• 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.

  PMID: 32750455 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Amniotic fluid, obtained during routine clinical management. Whole blood from live born children for renal function determination obtained during routine clinical management.

MeSH Terms

Conditions

Kidney Diseases

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Stéphane. DECRAMER, MD; PHD

  Néphrologie pédiatrique - Hôpital des enfants

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2015
• First Posted: February 5, 2016
• Study Start: December 1, 2010
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: November 29, 2024

Record last verified: 2024-11

Locations

FR (31)