Idiopathic Nephrotic SyndromeNEPHROVIR-2NCT01609426
Factors of Steroid Dependency in Idiopathic Nephrotic Syndrome
An observational study of Idiopathic Nephrotic Syndrome, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The primary purpose of the study is to identify the factors of steroid dependency in childhood idiopathic nephrotic syndrome. The steroid dependency is defined by a relapse of nephrotic syndrome within the 3 weeks that follow the withdrawal of steroid therapy after the first manifestation. Read more about this study
- Who is it for?
- Ages 6 months to 16 years
- Conditions the study is for
- Idiopathic Nephrotic Syndrome
- What is being tested?
- DNA chip dedicated to the pharmacogenetic of steroids
- How many people
- 351 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2012to Jun 2016
- 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 6 months to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Any children below 16 years of age with a first manifestation of idiopathic nephrotic syndrome commencing or having commenced in the Paris area
Who may be able to join
- children below 16 years
- first manifestation of nephrotic syndrome
- steroid sensitivity according to the recommendations of the french "pediatric society nephrology"
Who cannot join
- patients who don't stay in Paris during the study
Trial locations and contacts
1 site in 1 country.
France1 site
APHP Robert-Debré, Department of Pediatric Nephrology
Paris, 75020
About this study
The primary purpose of the study is to identify the factors of steroid dependency in childhood idiopathic nephrotic syndrome. The steroid dependency is defined by a relapse of nephrotic syndrome within the 3 weeks that follow the withdrawal of steroid therapy after the first manifestation. Different clinical and biological factors will be analyzed: age of first manifestation, delay of remission, ethnicity, and preceding viral infection, geolocalization in the Parisian area, genoprevalence of herpes viruses and polymorphisms in the genes involved in the response to steroid therapy.
Read the detailed description
Patients with a steroid dependent nephrotic syndrome will be compared to those with a non steroid dependent form of nephrotic syndrome at the end of the first manifestation. An additional blood volume will be sampled in patients and controls during a scheduled biological check-up for the initial disease. Genetics factors will be checked using a DNA chips devoted to the response to steroid therapy and viral genome of EBV, CMV, HHV7 will be searched for using PCR reaction in total blood DNA extract.
- Conditions
- Idiopathic Nephrotic Syndrome
- Being tested
- DNA chip dedicated to the pharmacogenetic of steroids
- Keywords
- Proteinuria, idiopathic, nephrotic syndrome, herpesvirus, epidemiology, immune response, interferon, steroid dependency, nephrotic disease: Idiopathic nephrotic syndrome
- Medical subject headings
- Nephrosis, Lipoid, Proteinuria, Nephrotic Syndrome, Herpes Simplex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA chip dedicated to the pharmacogenetic of steroidsGenetic
direct DNA extraction from peripheral blood cells
| Study group | Role | What they receive |
|---|---|---|
| children with idiopathic nephrotic syndrome | children below 16 years of age with a steroid dependent nephrotic syndrome Receives: Genetic: DNA chip dedicated to the pharmacogenetic of steroids |
What is being measured
The primary outcome is the main question the study is designed to answer.
define pharmacogenetic factors of steroid dependency
Measured: 28.5 months
Secondary outcomes (4)
parameters of the immune response against herpesvirus, specially the cellular production of interferon induced by specific viral peptides
Measured: 28.5 months
Dynamic of the epidemiology of idiopathic nephrotic syndrome in the Paris Area
Number of participants with idiopathic nephrotic syndrome in Paris Area to determinate if clusters cases exist.
Measured: 28.5 months
Analysis of cortico-dependence factors
Comparison of polymorphisms of cortico-dependent patients with non- cortico-dependent patients
Measured: Day 1
Analysis of susceptibility factors that generate the appearance of the Idiopathic Nephrotic Syndrome
Comparison of polymorphisms of all patients suffering from the Idiopathic Nephrotic Syndrome, with general population
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2012 (estimated)
- Study startSep 2012
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Nephrotic SyndromeStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 only
- Time perspective
- Other
- Enrolment
- 351 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Georges Deschênes, MD-PhD, Principal investigator, Assistance Publique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01609426
- Sponsor's protocol ID
- NI11021
- Other IDs
- AOM 11002
- Acronym
- NEPHROVIR-2
- Status last verified
- Mar 2017
- First submitted
- 25 Apr 2012
- Last updated
- 27 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors of Steroid Dependency in Idiopathic Nephrotic Syndrome
- ClinicalTrials.gov ID
- NCT01609426
- Acronym / sponsor ID
- NEPHROVIR-2 / NI11021
- Conditions
- Idiopathic Nephrotic Syndrome
- Keywords
- Proteinuria, idiopathic, nephrotic syndrome, herpesvirus, epidemiology, immune response, interferon, steroid dependency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 351 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Sep 2012 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 1 Jun 2012 (estimated)
- 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.
The primary purpose of the study is to identify the factors of steroid dependency in childhood idiopathic nephrotic syndrome. The steroid dependency is defined by a relapse of nephrotic syndrome within the 3 weeks that follow the withdrawal of steroid therapy after the first manifestation. Different clinical and biological factors will be analyzed: age of first manifestation, delay of remission, ethnicity, and preceding viral infection, geolocalization in the Parisian area, genoprevalence of herpes viruses and polymorphisms in the genes involved in the response to steroid therapy.
Detailed description
Patients with a steroid dependent nephrotic syndrome will be compared to those with a non steroid dependent form of nephrotic syndrome at the end of the first manifestation. An additional blood volume will be sampled in patients and controls during a scheduled biological check-up for the initial disease. Genetics factors will be checked using a DNA chips devoted to the response to steroid therapy and viral genome of EBV, CMV, HHV7 will be searched for using PCR reaction in total blood DNA extract.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| children with idiopathic nephrotic syndrome | – | Genetic: DNA chip dedicated to the pharmacogenetic of steroidschildren below 16 years of age with a steroid dependent nephrotic syndrome |
Who may qualify
- Ages
- 6 months to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Any children below 16 years of age with a first manifestation of idiopathic nephrotic syndrome commencing or having commenced in the Paris area
Key inclusion criteria (3 listed)
- children below 16 years
- first manifestation of nephrotic syndrome
- steroid sensitivity according to the recommendations of the french "pediatric society nephrology"
Key exclusion criteria (1 listed)
- patients who don't stay in Paris during 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DNA chip dedicated to the pharmacogenetic of steroidsdirect DNA extraction from peripheral blood cells | Genetic | children with idiopathic nephrotic syndrome |
Primary outcome
define pharmacogenetic factors of steroid dependency
Time frame: 28.5 months
4 secondary outcomes
parameters of the immune response against herpesvirus, specially the cellular production of interferon induced by specific viral peptides
Time frame: 28.5 months
Dynamic of the epidemiology of idiopathic nephrotic syndrome in the Paris Area
Time frame: 28.5 months
Analysis of cortico-dependence factors
Time frame: Day 1
Analysis of susceptibility factors that generate the appearance of the Idiopathic Nephrotic Syndrome
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2017.
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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.
Georges Deschênes, MD-PhD principal investigator
Assistance Publique
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 Idiopathic Nephrotic Syndrome, run by Assistance Publique - Hôpitaux de Paris 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: finished, as of the sponsor's last update on 27 Mar 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
define pharmacogenetic factors of steroid dependency (time frame: 28.5 months). 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 27 Mar 2017.