Clinical Trial: Validation of a Fetal Urine Peptidome-based Classifier to Predict Post-natal Renal Function in Posterior Urethral Valves

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Multicentre Validation of a Fetal Urine Peptidome-based Classifier to Predict Post-natal Renal Function in Posterior Urethral Valves

Brief Summary: Validate the use of fetal urine peptidome-analysis for the stratification of fetuses with Posterior Urethral Valve for post-natal renal function.

Detailed Summary:

The ANTENATAL project requires the use of fetal urine as well as post-natal urine, post-natal serum and, possibly, amniotic liquid. We will take an additional tube during the takings collected for routine management of the disease.

The analysis of samples will be carried out in Toulouse at the Institute of Metabolic and Cardiovascular Diseases or with fee-for-service suppliers.


Sponsor: University Hospital, Toulouse

Current Primary Outcome: Renal/patient survival at 2 years post-natally. [ Time Frame: Year 2 ]

Defined by the need for dialysis or death.


Original Primary Outcome: Same as current

Current Secondary Outcome: Renal function of the survivors at day 4 and 6 and 12 month post-natally. [ Time Frame: Year 1 ]

This post-natal renal function, estimated via serum cystatin C concentrations, will be analysed centrally in Toulouse to homogenise the analysis.


Original Secondary Outcome: Same as current

Information By: University Hospital, Toulouse

Dates:
Date Received: March 10, 2017
Date Started: May 1, 2017
Date Completion: August 31, 2022
Last Updated: April 28, 2017
Last Verified: April 2017