Transient Pseudohypoaldosteronism Affecting Children With... | NCT06905600

Studies
Transient Pseudohypoaldosteronism Affecting Children With Urinary Tract Malformation

NCT06905600

Sponsor

University Hospital, Strasbourg, France

Status

Recruiting

Last Update Posted

Apr 1, 2025Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Pseudohypoaldosteronism

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

Jul 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 31, 2024Actual

Primary Completion Date

Dec 2025Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Jul 8, 2024

First Submission Date that Met QC Criteria

Mar 25, 2025

First Posted Date

Apr 1, 2025Actual

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

Mar 25, 2025

Last Update Posted Date

Apr 1, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

Pseudohypoaldosteronism is a pathology affecting children under 6 months of age, little known but which can have serious consequences.

There are no real figures on the prevalence of this pathology in France. The exact pathophysiology is not known and the management is not currently codified.

This is why it is interesting to study this pathology and its treatment on a national scale in order to think about the best possible treatment, as well as to raise awareness of this pathology among different health professionals.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
National comparison of clinical and therapeutic practices concerning the management of pseudohypoaldosteronism in children with urinary malformations and/or urinary infections	This study compares clinical and therapeutic practices The retrospective analysis of the data will be carried out using classic statistical tests (Student's test, Fisher's test, ROC curve)	Up to 1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Minor subjects aged less than 6 years at the time of diagnosis
Diagnosis of pseudohypoaldosteronism in the context of urinary malformation and/or urinary infection between January 1, 2018 and December 31, 2023
Subject (and/or their parental authority) having not expressed, after information, their opposition to the reuse of their data for the purposes of this research.

Exclusion Criteria:

Subject (or their parents) having expressed their (their) opposition to participating in the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

6 Years

Standard Ages

Child

Study Population

Minor subjects aged less than 6 years at the time of diagnosis of pseudohypoaldosteronism in the context of urinary malformation and/or urinary infection between January 1, 2018 and December 31, 2023

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ariane ZALOSZYC, MD	Contact	33 3 88 12 77 42		ariane.zaloszyc@chru-strasbourg.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service pédiatrie 1 - CHU de Strasbourg - France	Recruiting	Strasbourg		67091	France

Condition Browse Module

MeSH Terms

ID	Term
D011546	Pseudohypoaldosteronism

Ancestor Terms

ID	Term
D015499	Renal Tubular Transport, Inborn Errors
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided