Nephrotic SyndromeMISS-NNCT03592030
Diagnostic and Prognostic Value of Miss-1 Study in Children and Adult With Nephrotic Syndrome MISSNEPHROTIQUE
An observational study of Nephrotic Syndrome, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The nephrotic syndrome is a rare disease defined by a proteinuria >3g/24h and a hypoalbuminemia < 30g/L. Genetic and immune are the main causes. The acquired idiopathic nephrotic syndrome presents histologically minimal glomerular lesions, sometimes associated with segmental and focal hyalinosis. Read more about this study
- Who is it for?
- Ages 12 months and older
- Conditions the study is for
- Nephrotic Syndrome
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2016to Dec 2018
- 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 12 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All nephrotic patients from the participating centers
Who may be able to join
- All new hospitalized patient
- Presenting a nephrotic syndrome according to its definition
- For which an anatomopathological diagnostic and its evolution can be or will be carried
- Children of any age can be included if they present a nephrotic syndrome
Who cannot join
- Patients already treated with glucocorticoids and/or immunosuppressor
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de Néphrologie et Dialyses Paris, Hôpital Tenon
Paris, 75020
Jean-Jacques BOFFA, Professor, 00 33 1 56 01 60 29, jean-jacques.boffa@aphp.fr
About this study
The nephrotic syndrome is a rare disease defined by a proteinuria >3g/24h and a hypoalbuminemia < 30g/L. Genetic and immune are the main causes. The acquired idiopathic nephrotic syndrome presents histologically minimal glomerular lesions, sometimes associated with segmental and focal hyalinosis. The idiopathic nephrotic syndrome (INS) represents 85% of children's glomerular nephropathy and 25-30% of adult's.
Relapses are frequents, and can be pejorative up to 10% and lead to end-stage kidney failure.
Read more
Another immune cause is the extramembranous glomerulonephritis mediated by molecular targets specific autoantibodies expressed at the podocytes surface.
Other immune causes include lupus nephropathy, ANCA vascularitis, Goodpasture disease, Berger disease.
Easy diagnosis between these causes can be made with the renal biopsy.
Miss-1, a new protein activated during a inflammatory event, could be an actor in nephrotic syndromes by modifying the podocyte's adhesion on the glomerular basal membrane. This would modulate the structure and function of the slit diaphragm, as well as junctions between the podocyte and the glomerular basal membrane, regulating podocytes' apoptosis.
Read the detailed description
This project is meant to propose and validate specific and non-invasive diagnostic and prognostic tests for the acquired idiopathic nephrotic syndrome.
These tests rely on the measure of Miss-1 expression in circulating blood cells on flow cytometry and its plasmatic concentration.
To date, no equivalent tests exist to diagnose idiopathic nephrotic syndrome (INS) from other causes.
These simple tests would allow a quick diagnosis of acquired INS by avoiding an invasive renal biopsy. It would also help anticipate the relapses of the disease and guide the treatment modalities as do nowadays the PLA2R antibodies in idiopathic membranous nephropathy.
We will propose the tests to every consent patient, hospitalized in the participating centers (Néphrologie pédiatrique of Robert Debré hospital, Néphrologie adulte of Tenon hospital) with a nephrotic syndrome.
- Conditions
- Nephrotic Syndrome
- Keywords
- Idiopathic nephrotic syndrome, Minimal change diseases, Primitive FSGS
- Medical subject headings
- Nephrotic Syndrome, Nephrosis, Lipoid
What is being measured
The primary outcome is the main question the study is designed to answer.
Miss1 expression in circulating blood cells on flow cytometry at the time of diagnostic of nephrotic syndrome.
Sensitivity of the Miss1 test: The diagnosis will be made if the expression of Miss1 of circulating leukocytes in flow cytometry at the time of the diagnosis of nephrotic syndrome is> 20 times the mean value of the healthy controls.
Measured: From Day 0 to 1 month
Secondary outcomes (3)
Miss1 plasmatic concentration at the time of the diagnostic of nephrotic syndrome
Sensitivity of plasma Miss1 concentration for INS diagnosis. Specificity, PPV, NPV of the test in the child. Sensitivity, specificity, PPV, NPV of the diagnostic test of the monocyte and granulocyte membrane expression, of lymphocyte subpopulations, Treg and Th17, of the Miss-1 in flow cytometry at the time of the diagnosis of nephrotic syndrome> at a threshold.
Measured: From Day 0 to 1 month
Miss1 expression in circulating blood cells on flow cytometry after remission
Measured: After remission, up to 1 month
Miss1 plasmatic concentration after remission
Measured: After remission, up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study startJan 2016
- Primary completionOct 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Jacques Boffa, Professor, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03592030
- Sponsor's protocol ID
- NI17036
- Acronym
- MISS-N
- Status last verified
- Jun 2018
- First submitted
- 9 Jul 2018
- Last updated
- 19 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shalhoub RJ. Pathogenesis of lipoid nephrosis: a disorder of T-cell function. Lancet. 1974 Sep 7;2(7880):556-60. doi: 10.1016/s0140-6736(74)91880-7.
PubMed 4140273Eddy AA, Symons JM. Nephrotic syndrome in childhood. Lancet. 2003 Aug 23;362(9384):629-39. doi: 10.1016/S0140-6736(03)14184-0.
PubMed 12944064van den Berg JG, Weening JJ. Role of the immune system in the pathogenesis of idiopathic nephrotic syndrome. Clin Sci (Lond). 2004 Aug;107(2):125-36. doi: 10.1042/CS20040095.
PubMed 15157184
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic and Prognostic Value of Miss-1 Study in Children and Adult With Nephrotic Syndrome MISSNEPHROTIQUE
- ClinicalTrials.gov ID
- NCT03592030
- Acronym / sponsor ID
- MISS-N / NI17036
- Conditions
- Nephrotic Syndrome
- Keywords
- Idiopathic nephrotic syndrome, Minimal change diseases, Primitive FSGS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 19 Jul 2018 (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.
The nephrotic syndrome is a rare disease defined by a proteinuria >3g/24h and a hypoalbuminemia < 30g/L. Genetic and immune are the main causes. The acquired idiopathic nephrotic syndrome presents histologically minimal glomerular lesions, sometimes associated with segmental and focal hyalinosis. The idiopathic nephrotic syndrome (INS) represents 85% of children's glomerular nephropathy and 25-30% of adult's.
Relapses are frequents, and can be pejorative up to 10% and lead to end-stage kidney failure.
Another immune cause is the extramembranous glomerulonephritis mediated by molecular targets specific autoantibodies expressed at the podocytes surface.
Other immune causes include lupus nephropathy, ANCA vascularitis, Goodpasture disease, Berger disease.
Easy diagnosis between these causes can be made with the renal biopsy.
Miss-1, a new protein activated during a inflammatory event, could be an actor in nephrotic syndromes by modifying the podocyte's adhesion on the glomerular basal membrane. This would modulate the structure and function of the slit diaphragm, as well as junctions between the podocyte and the glomerular basal membrane, regulating podocytes' apoptosis.
Detailed description
This project is meant to propose and validate specific and non-invasive diagnostic and prognostic tests for the acquired idiopathic nephrotic syndrome.
These tests rely on the measure of Miss-1 expression in circulating blood cells on flow cytometry and its plasmatic concentration.
To date, no equivalent tests exist to diagnose idiopathic nephrotic syndrome (INS) from other causes.
These simple tests would allow a quick diagnosis of acquired INS by avoiding an invasive renal biopsy. It would also help anticipate the relapses of the disease and guide the treatment modalities as do nowadays the PLA2R antibodies in idiopathic membranous nephropathy.
We will propose the tests to every consent patient, hospitalized in the participating centers (Néphrologie pédiatrique of Robert Debré hospital, Néphrologie adulte of Tenon hospital) with a nephrotic syndrome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All nephrotic patients from the participating centers
Key inclusion criteria (4 listed)
- All new hospitalized patient
- Presenting a nephrotic syndrome according to its definition
- For which an anatomopathological diagnostic and its evolution can be or will be carried
- Children of any age can be included if they present a nephrotic syndrome
Key exclusion criteria (1 listed)
- Patients already treated with glucocorticoids and/or immunosuppressor
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
Miss1 expression in circulating blood cells on flow cytometry at the time of diagnostic of nephrotic syndrome.
Time frame: From Day 0 to 1 month
Sensitivity of the Miss1 test: The diagnosis will be made if the expression of Miss1 of circulating leukocytes in flow cytometry at the time of the diagnosis of nephrotic syndrome is> 20 times the mean value of the healthy controls.
3 secondary outcomes
Miss1 plasmatic concentration at the time of the diagnostic of nephrotic syndrome
Time frame: From Day 0 to 1 month
Miss1 expression in circulating blood cells on flow cytometry after remission
Time frame: After remission, up to 1 month
Miss1 plasmatic concentration after remission
Time frame: After remission, up to 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2018.
- Background: PubMed 4140273Shalhoub RJ. Pathogenesis of lipoid nephrosis: a disorder of T-cell function. Lancet. 1974 Sep 7;2(7880):556-60. doi: 10.1016/s0140-6736(74)91880-7.
- Background: PubMed 12944064Eddy AA, Symons JM. Nephrotic syndrome in childhood. Lancet. 2003 Aug 23;362(9384):629-39. doi: 10.1016/S0140-6736(03)14184-0.
- Background: PubMed 15157184van den Berg JG, Weening JJ. Role of the immune system in the pathogenesis of idiopathic nephrotic syndrome. Clin Sci (Lond). 2004 Aug;107(2):125-36. doi: 10.1042/CS20040095.
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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.
Jean-Jacques Boffa, Professor principal investigator
Assistance Publique - Hôpitaux de Paris
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 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 4 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 19 Jul 2018. 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 Jean-Jacques Boffa, Professor (00 33 1 56 01 60 29, jean-jacques.boffa@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Miss1 expression in circulating blood cells on flow cytometry at the time of diagnostic of nephrotic syndrome. (time frame: From Day 0 to 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03592030, which also lists 3 linked publications.
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 19 Jul 2018.