Predicting kidney function in newborns with urinary tract issues using fetal urine analysis
Multicentre Validation of a Fetal Urine Peptidome-based Classifier to Predict Post-natal Renal Function in Posterior Urethral Valves
University Hospital, Toulouse · NCT03116217
This study is testing if analyzing fetal urine can help predict kidney function in newborns with urinary tract problems.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Female |
| Sponsor | University Hospital, Toulouse (other) |
| Locations | 29 sites (Leuven and 28 other locations) |
| Trial ID | NCT03116217 on ClinicalTrials.gov |
What this trial studies
This observational study aims to validate a classifier based on fetal urine peptidome analysis to predict post-natal renal function in fetuses diagnosed with Posterior Urethral Valves. It involves collecting fetal urine, post-natal urine, post-natal serum, and possibly amniotic fluid to explore potential biomarkers. The analysis will be conducted at the Institute of Metabolic and Cardiovascular Diseases in Toulouse or through fee-for-service suppliers. The goal is to improve the stratification of affected fetuses for better clinical outcomes.
Who should consider this trial
Good fit: Ideal candidates include male singleton fetuses diagnosed with megabladder and urinary tract anomalies confirmed by ultrasound.
Not a fit: Patients who do not have urinary tract anomalies or those who refuse to participate in the study may not benefit.
Why it matters
Potential benefit: If successful, this study could lead to improved predictions of renal function in newborns, allowing for better management and treatment strategies.
How similar studies have performed: While this approach is innovative, similar studies have not been widely reported, indicating a novel exploration in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * male singleton fetus with megabladder associated with urinary tract anomalies with or without dysplastic or hyperechogenic parenchyma detected in a first ultrasound; * megabladder confirmed in a second ultrasound; * collection of fetal urine taken during the routine management of the disease for the dosage of ß2-microglobulin; * written informed consent. Exclusion Criteria: * refusal to participate in the study; * person protected by law.
Where this trial is running
Leuven and 28 other locations
- UZ Leuven — Leuven, Belgium (NOT_YET_RECRUITING)
- CHU Pellegrin-Bordeaux — Bordeaux, France (ACTIVE_NOT_RECRUITING)
- CHRU de Brest - Hôpital Morvan — Brest, France (ACTIVE_NOT_RECRUITING)
- Hôpital Femme Mère Enfant-Lyon — Bron, France (ACTIVE_NOT_RECRUITING)
- CH René-Dubos — Cergy Pontoise, France (ACTIVE_NOT_RECRUITING)
- CHU Estaing — Clermont-Ferrand, France (NOT_YET_RECRUITING)
- CHU de Grenoble - Hôpital Couple-Enfant - Département de la Génétique — Grenoble, France (ACTIVE_NOT_RECRUITING)
- CHU de la Timone — Marseille, France (ACTIVE_NOT_RECRUITING)
- Centre Hospitalier Universitaire de Montpellier — Montpellier, France (ACTIVE_NOT_RECRUITING)
- Hôpital mère-enfant pédiatrie — Nantes, France (RECRUITING)
- CHU Lenval — Nice, France (NOT_YET_RECRUITING)
- AP-HP - Hôpital Necker Enfants malades — Paris, France (NOT_YET_RECRUITING)
- Hôpital Robert-Debré — Paris, France (NOT_YET_RECRUITING)
- CHU Poitiers — Poitiers, France (ACTIVE_NOT_RECRUITING)
- CHU Rennes Hôpital Sud — Rennes, France (ACTIVE_NOT_RECRUITING)
- CHU Hôpitaux de St-Etienne-Hôpital Nord — Saint Etienne, France (ACTIVE_NOT_RECRUITING)
- Centre hospitalier universitaire Chu Amiens Salouël Hôpital sud — Salouel, France (ACTIVE_NOT_RECRUITING)
- Sihcus-Cmco — Schiltigheim, France (RECRUITING)
- Hôpital Bagatelle (Talence) - CHU Pellegrin (Bordeaux) — Talence, France (NOT_YET_RECRUITING)
- Hôpital Paule de Viguier-Hôpital des enfants- Site Purpan — Toulouse, France (RECRUITING)
- Centre Olympe de Gouges du CHRU de Tours — Tours, France (NOT_YET_RECRUITING)
- Heidelberg University Hospital — Heidelberg, Germany (NOT_YET_RECRUITING)
- Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico — Milan, Italy (NOT_YET_RECRUITING)
- Leiden University Medical Center Dept of prenatal diagnosis and therapy — Leiden, The Netherlands, Netherlands (NOT_YET_RECRUITING)
- Radboudumc Amalia Children's Hospital — Nijmegen, The Netherlands, Netherlands (NOT_YET_RECRUITING)
- Polish Mothers Memorial Hospital Research Institute — Lodz, Poland (NOT_YET_RECRUITING)
- Hospital Universitari Vall d'Hebron — Barcelona, Spain (NOT_YET_RECRUITING)
- Hôpital des Enfants Hôpitaux universitaire Genève (HUG) — Geneve, Switserland, Switzerland (NOT_YET_RECRUITING)
- FetalMedicine Centre Birmingham Women's Hospital — Birmingham, United Kingdom (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Stéphane DECRAMER, Pr — CHU Toulouse
- Study coordinator: Stéphane DECRAMER, Pr
- Email: decramer.s@chu-toulouse.fr
- Phone: 5 34 55 84 58
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Posterior Urethral Valves, renal function, post natal, peptidome