PseudohypoaldosteronismTPHANCT06905600
Transient Pseudohypoaldosteronism Affecting Children With Urinary Tract Malformation
An observational study of Pseudohypoaldosteronism, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 6 years
- Conditions the study is for
- Pseudohypoaldosteronism
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 31 Jan 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 6 years
- All sexes
- No healthy volunteers
- 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
Who may be able to join
- 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.
Who cannot join
- Subject (or their parents) having expressed their (their) opposition to participating in the study
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service pédiatrie 1 - CHU de Strasbourg - France
Strasbourg, 67091
Ariane ZALOSZYC, MD, 33 3 88 12 77 42, ariane.zaloszyc@chru-strasbourg.fr
Ariane ZALOSZYC, MD
About this study
Official title: Transient Pseudohypoaldosteronism Affecting Children With Urinary Tract Malformation: Diagnosis and Management in a French Retrospective Study
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.
- Conditions
- Pseudohypoaldosteronism
- Keywords
- Pseudohypoaldosteronism, pseudohypoaldosteronism in children
- Medical subject headings
- Pseudohypoaldosteronism
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start31 Jan 2024
- Primary completionDec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PseudohypoaldosteronismStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06905600
- Sponsor's protocol ID
- 9139
- Acronym
- TPHA
- Status last verified
- Jul 2024
- First submitted
- 8 Jul 2024
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transient Pseudohypoaldosteronism Affecting Children With Urinary Tract Malformation: Diagnosis and Management in a French Retrospective Study
- ClinicalTrials.gov ID
- NCT06905600
- Acronym / sponsor ID
- TPHA / 9139
- Conditions
- Pseudohypoaldosteronism
- Keywords
- Pseudohypoaldosteronism, pseudohypoaldosteronism in children
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 31 Jan 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 1 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Subject (or their parents) having expressed their (their) opposition to participating in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
National comparison of clinical and therapeutic practices concerning the management of pseudohypoaldosteronism in children with urinary malformations and/or urinary infections
Time frame: Up to 1 year
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pseudohypoaldosteronism, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ariane ZALOSZYC, MD (33 3 88 12 77 42, ariane.zaloszyc@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
National comparison of clinical and therapeutic practices concerning the management of pseudohypoaldosteronism in children with urinary malformations and/or urinary infections (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.