Renal HYPODYSPLASIA : Genetic and Familial Assessment | NCT00925379

Studies
Renal HYPODYSPLASIA : Genetic and Familial Assessment

NCT00925379

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Completed

Last Update Posted

Nov 20, 2025Actual

Enrollment

342Actual

Phase

Not provided

Conditions

Renal HYPODYSPLASIA, Nonsyndromic, 1

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

Apr 2013Actual

Completion Date

Jul 2014Actual

First Submitted Date

Jun 19, 2009

First Submission Date that Met QC Criteria

Jun 19, 2009

First Posted Date

Jun 22, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 17, 2025

Last Update Posted Date

Nov 20, 2025Actual

Name	Class
URC-CIC Paris Descartes Necker Cochin	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Evaluation of the frequency of familial cases of renal HYPODYSPLASIA

Detailed Description

DNA collection from the propositus and its family. A questionnaire will be filled by the parents to seek other affected individual in the family.With another affected member, DNA collection will be collected from the whole family.

A renal ultrasound will be prescribed for the parents, brothers and sisters.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

342Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluation of the heritability of renal HYPODYSPLASIA (on the renal ultra sound) and DNA collection to make possible identification of predisposing genes		the same day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria :

- Children aged more than 3 months and less than 18 years old with a renal bilateral HYPODYSPLASIA set by renal ultrasound examination :

renal size < -2DS
with/or hyperechogenicity or lack of cortical-medullary differentiation
with/or renal cysts

Exclusion criteria :

Bladder uropathy or sus-bladder uropathy
Recessive or dominant renal polycystic disease
Bardet-Biedl syndrome and other malformative syndromes except renal coloboma syndrome, Renal cysts and diabetes syndrome RCAD
Lack of written informed consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Months

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Children with a bilateral renal hypodysplasia

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Remi Salomon, MD, PhD	Assistance Publique - Hôpitaux de Paris	Principal Investigator
Vincent Guigonis, MD, PhD	University Hospital, Limoges	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Necker Hospital		Paris		75015	France

Condition Browse Module

MeSH Terms

ID	Term
C563661	Renal Hypodysplasia, Nonsyndromic, 1

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided