Proteomic Analysis of Amniotic Fluid to Predict Postnatal Renal Function in Fetuses With Renal and Urinary Tract Malformations

NCT06912490 | Recruiting

• 2 other identifiers: RC31/24/0291ID-RCB : 2024-A01612-45
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this project is to validate a previously established amniotic fluid 98 peptide signature predictive of post-natal outcome in fetuses with congenital anomalies of the kidney and the urinary tract (CAKUT) in a "real" clinical context. It includes the feasibility of collecting, transporting and analyzing the amniotic fluid peptidome from clinical centers all over France and of providing the result in a clinically accepted time-frame. Therefore, this multicenter study will not only allow to determine the added value of such new prenatal test but also to ensure the feasibility of its introduction in the management of CAKUT pregnancies.

Conditions

Kidney Diseases

Keywords

Antenatal; fetal bilateral nephropathies; renal function; prognosis; proteomic analysis; renal ultrasound

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity of the test in the evaluation of renal survival (need for dialysis) and patient survival at 2 years of life.

  Renal survival is defined as the absence of end-stage renal disease (ESRD) requiring dialysis by 2 years of age. Patient survival is defined as the child being alive at 2 years. Renal function is assessed through clinical follow-up, including serum creatinine measurements and estimated glomerular filtration rate (eGFR) using the Schwartz formula. Dialysis initiation is determined based on standard clinical criteria for ESRD. Survival status is confirmed through medical records and follow-up visits. This outcome aims to validate the predictive value of the 98-peptide amniotic fluid signature for postnatal kidney function in CAKUT fetuses.

  2 years of age

Secondary Outcomes (2)

• Sensitivity and specificity of the test in the evaluation of postnatal renal function estimated by the Schwartz formula and his serum creatinine

  At months 1, 6, 12, and 24 postnatally

• Severity score result rendering time

  up to 2 weeks after sample collection

Study Arms (1)

Proteomic-Based Prediction of Postnatal Kidney Function in Fetuses with Bilateral CAKUT

EXPERIMENTAL

Other: Amniotic Fluid Proteomic Analysis Using Capillary Electrophoresis-Mass Spectrometry (CE-MS)

Interventions

Amniotic Fluid Proteomic Analysis Using Capillary Electrophoresis-Mass Spectrometry (CE-MS) OTHER

This intervention consists of analyzing the amniotic fluid proteome using capillary electrophoresis coupled with mass spectrometry (CE-MS). The goal is to evaluate a predefined 98-peptide signature that predicts postnatal kidney function in fetuses with bilateral congenital anomalies of the kidney and urinary tract. Unlike standard prenatal assessments based on ultrasound and fetal biochemistry, this method provides a molecular-based prognostic tool to improve decision-making regarding pregnancy management and neonatal care

Proteomic-Based Prediction of Postnatal Kidney Function in Fetuses with Bilateral CAKUT

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All fetuses with bilateral renal development anomalies with structural changes in the parenchyma, with or without associated urinary tract anomalies;
• Signed informed consent of the mother
• Non-opposition of the father.

You may not qualify if:

• Unilateral abnormality of renal development
• Any pregnancy for which amniocentesis may represent a risk for the fetus or the mother
• Twin pregnancies
• Pregnant woman protected by law (guardianship, curatorship)

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Children Hospital

Toulouse, 31059, France

RECRUITING

MeSH Terms

Conditions

Kidney Diseases

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Thomas SIMON

CONTACT

05 34 55 84 58; simon.t@chu-toulouse.fr

Nadège Algans

CONTACT

+33 05 61 77 72 04; algans.n@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: April 4, 2025
• Study Start: July 18, 2025
• Primary Completion (Estimated): December 20, 2029
• Study Completion (Estimated): December 20, 2029
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

FR (1)