Primary HyperoxaluriaPHENO-HOPLANCT05107830
Phenotyping of Primary Hyperoxaluria
An observational study of Primary Hyperoxaluria, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
985 / 5000 Résultats de traduction Primary hyperoxaluria is a rare autosomal recessive disease with an estimated prevalence of around 1 to 3 cases per million population. The most frequent attacks are urolithiasis disease and nephrocalcinosis, ultimately leading to end-stage chronic renal failure. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Primary Hyperoxaluria
- How many people
- 186 participants
- Where
- 1 siteFrance
- Study dates
- 22 Jan 2021to Jan 2023
- 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 and older
- All sexes
- Child, Adult, Older adult
Study population: Major or minor subject having undergone genetic research for primary hyperoxaluria between 01/01/2015 and 31/12/2019
Who may be able to join
- Major or minor subject having undergone genetic research for primary hyperoxaluria between 01/01/2015 and 31/12/2019
- Major subject not having expressed, after information, the reuse of his data for the purposes of this research
- Child and holders of parental authority who have not expressed, after information, the reuse of their data for the purposes of this research
Who cannot join
- Subject (or his parental authority if he is a minor) who has expressed his opposition to participating in the study
- Subject not residing in France
- Subject of foreign nationality
- Subject under tutorship or curatorship
- Subject under safeguard of justice
Trial locations and contacts
1 site in 1 country.
Saïd CHAYER, PhD, HDR contact
France1 site, 1 recruiting
- Recruiting
Service de Néphrologie et Transplantation - Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Bruno MOULIN, MD, PhD, 33 3 69 55 05 11, Bruno.Moulin@chru-strasbourg.fr
Saïd CHAYER, PhD, HDR, said.chayer@chru-strasbourg.fr
About this study
Official title: Phenotyping of Primary Hyperoxaluria in Children and Adults
985 / 5000 Résultats de traduction Primary hyperoxaluria is a rare autosomal recessive disease with an estimated prevalence of around 1 to 3 cases per million population. The most frequent attacks are urolithiasis disease and nephrocalcinosis, ultimately leading to end-stage chronic renal failure. The phenotype of this pathology is very heterogeneous, making the diagnosis difficult.
There is currently a significant diagnostic delay. This is potentially due to atypical forms, or to insufficient clinicians' awareness of its research.
Read more
However, the early diagnosis of this pathology is essential, since end-stage chronic renal failure can be avoided or at least delayed with early and appropriate management.
The objective of the study is to describe the phenotype of currently diagnosed primary hyperoxaluria, in order to identify the classic presentations but also the characteristics of atypical presentations
- Conditions
- Primary Hyperoxaluria
- Keywords
- Primary hyperoxaluria, Autosomal recessive, Urolithiasis., Nephrocalcinosis, Renal failure
- Medical subject headings
- Hyperoxaluria, Primary, Urolithiasis, Nephrocalcinosis, Renal Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Retropsective study of classic presentations of atypical presentations of primitive hyperoxaluria and its characteristics of atypical presentations
Measured: Files analysed retrospectively from January 01, 2015 to December 31, 2019 will be examined]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study start22 Jan 2021
- Primary completionJan 2023 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary HyperoxaluriaStudies of the same condition, open and under way.
- 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
- 186 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
- NCT05107830
- Sponsor's protocol ID
- 8071
- Acronym
- PHENO-HOPLA
- Status last verified
- Oct 2021
- First submitted
- 13 Oct 2021
- Last updated
- 4 Nov 2021
- 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 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenotyping of Primary Hyperoxaluria in Children and Adults
- ClinicalTrials.gov ID
- NCT05107830
- Acronym / sponsor ID
- PHENO-HOPLA / 8071
- Conditions
- Primary Hyperoxaluria
- Keywords
- Primary hyperoxaluria, Autosomal recessive, Urolithiasis., Nephrocalcinosis, Renal failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 22 Jan 2021 (actual)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 4 Nov 2021 (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.
985 / 5000 Résultats de traduction Primary hyperoxaluria is a rare autosomal recessive disease with an estimated prevalence of around 1 to 3 cases per million population. The most frequent attacks are urolithiasis disease and nephrocalcinosis, ultimately leading to end-stage chronic renal failure. The phenotype of this pathology is very heterogeneous, making the diagnosis difficult.
There is currently a significant diagnostic delay. This is potentially due to atypical forms, or to insufficient clinicians' awareness of its research.
However, the early diagnosis of this pathology is essential, since end-stage chronic renal failure can be avoided or at least delayed with early and appropriate management.
The objective of the study is to describe the phenotype of currently diagnosed primary hyperoxaluria, in order to identify the classic presentations but also the characteristics of atypical presentations
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Major or minor subject having undergone genetic research for primary hyperoxaluria between 01/01/2015 and 31/12/2019
Key inclusion criteria (3 listed)
- Major or minor subject having undergone genetic research for primary hyperoxaluria between 01/01/2015 and 31/12/2019
- Major subject not having expressed, after information, the reuse of his data for the purposes of this research
- Child and holders of parental authority who have not expressed, after information, the reuse of their data for the purposes of this research
Key exclusion criteria (5 listed)
- Subject (or his parental authority if he is a minor) who has expressed his opposition to participating in the study
- Subject not residing in France
- Subject of foreign nationality
- Subject under tutorship or curatorship
- Subject under safeguard of justice
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
Retropsective study of classic presentations of atypical presentations of primitive hyperoxaluria and its characteristics of atypical presentations
Time frame: Files analysed retrospectively from January 01, 2015 to December 31, 2019 will be examined]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2021.
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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.
Saïd CHAYER, PhD, HDR contact
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 Primary Hyperoxaluria, 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 5 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 4 Nov 2021. 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 Bruno MOULIN, MD, PhD (33 3 69 55 05 11, Bruno.Moulin@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retropsective study of classic presentations of atypical presentations of primitive hyperoxaluria and its characteristics of atypical presentations (time frame: Files analysed retrospectively from January 01, 2015 to December 31, 2019 will be examined]). 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 4 Nov 2021.