Overview

This trial is active, not recruiting.

Condition renal fibrosis
Treatment elastography
Sponsor Assistance Publique Hopitaux De Marseille
Start date January 2011
End date July 2014
Trial size 100 participants
Trial identifier NCT01613625, 2010-10, 2010-A00950-39

Summary

Elastography is a emerging imaging technique that has demonstrated high reliability in the assessment of tissues stiffness and quantification of fibrosis particularly in adult's livers. This ultrasound exploration has no secondary effects. There is no study published in the pediatric population concerning the role of ultrasound elastrography in kidney. The aim of this study is to look for a correlation between the elastography's results and the kidney fibrosis on children who have to undergo a renal biopsy. Elastography may play a potential diagnostic and/or prognostic role in the management of these patients which would limit invasive biopsy procedures.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
elastography

Primary Outcomes

Measure
the elastography
time frame: 30 months

Secondary Outcomes

Measure
The dosage of the créatininémie
time frame: 30 months
the debit of filtration glomérulaire at the child
time frame: 30 MONTHS

Eligibility Criteria

Male or female participants from 5 years up to 18 years old.

Inclusion Criteria: - Male children or feminine from 5 to 18 years old to whom is indicated a renal biopsy by the néphrologue paediatrician whatever is the initial pathology, whatever are one or several current or previous treatments and whatever is their associated comorbidity Exclusion Criteria: - Children of less than 5 years old or more than 18 years - Children for whom a draining renal biopsy is not or more indicated by néphrologues - Refusal or withdrawal of the consent lit by the holders of the exercise of the parental authority or by the child if he is capable of receiving the information - Contraindication in the realization of a draining renal biopsy (current infection, disorder of the coagulation.)

Additional Information

Official title Interest Of Renal Elastography In Children As A Diagnostic Tool Of Renal Fibrosis: Confrontation To Histological Features Of Renal Biopsies
Principal investigator alix RUOCCO
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by Assistance Publique Hopitaux De Marseille.