Amniotic fluid protein test to predict newborn kidney function in pregnancies with fetal kidney abnormalities
Official title: Proteomic Analysis of Amniotic Fluid to Predict Postnatal Renal Function in Fetuses With Renal and Urinary Tract Malformations
Run by University Hospital, Toulouse · NCT06912490 · Data updated 2026-11-12
This project will test whether a 98-peptide signature measured in amniotic fluid can predict postnatal kidney function in fetuses with bilateral renal and urinary tract malformations.
Quick facts
| Study type | Interventional |
|---|---|
| Sex | Women only |
| Enrollment | 78 (estimated) |
| Sponsor | University Hospital, Toulouse Academic / other |
| Locations | 1 site (Toulouse) |
| Status | Recruiting |
| Started | July 18, 2025 |
| Main results expected | December 20, 2029 |
| Study ends | December 20, 2029 |
| Registry record updated | May 4, 2026 |
| Trial ID | NCT06912490 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Pregnant people carrying a singleton fetus with bilateral kidney parenchymal abnormalities (with or without urinary tract anomalies) who can undergo amniocentesis and provide informed consent are ideal candidates.
✕Probably not a fit
People with unilateral renal abnormalities, twin pregnancies, pregnancies where amniocentesis is contraindicated, or those under legal protection (guardianship/curatorship) are unlikely to benefit from this test.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Researchers will enroll pregnancies with prenatally diagnosed bilateral renal parenchymal abnormalities at participating French centers and collect amniotic fluid during clinically indicated amniocentesis. Samples will be shipped to a central laboratory for proteomic analysis using capillary electrophoresis–mass spectrometry to measure a previously identified 98-peptide signature. The study will compare the signature results to actual postnatal kidney function to measure predictive performance and determine clinical added value. The trial will also test the feasibility of sample collection, transport, and returning results within a clinically useful timeframe across multiple centers in France.
Why it matters
Potential benefit: If successful, the test could give parents and clinicians more accurate prenatal prognosis, helping guide decisions about pregnancy management and preparation for dialysis, transplantation, or palliative care.
How similar studies have gone: A prior single-center report (Klein et al., Kidney International 2021) showed that the 98-peptide amniotic fluid signature predicted postnatal kidney function with high sensitivity and specificity, and this study aims to validate that finding across multiple centers.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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)
Where it's running
-
Children Hospital
Toulouse, France Recruiting
Study contacts
- Study coordinator: Thomas SIMON
- Email: simon.t@chu-toulouse.fr
- Phone: 05 34 55 84 58
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.