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Diagnostic and Prognostic Value of Miss-1 Study in Children and Adult With Nephrotic Syndrome MISSNEPHROTIQUE (MISS-N)

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ClinicalTrials.gov Identifier: NCT03592030
Recruitment Status : Recruiting
First Posted : July 19, 2018
Last Update Posted : July 19, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief 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. 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.


Condition or disease
Nephrotic Syndrome

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.


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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Diagnostic and Prognostic Value of Miss-1 Study in Children and Adult With Nephrotic Syndrome MISSNEPHROTIQUE
Actual Study Start Date : January 2016
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : December 2018





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Miss1 plasmatic concentration at the time of the diagnostic of nephrotic syndrome [ Time Frame: From Day 0 to 1 month ]
    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.

  2. Miss1 expression in circulating blood cells on flow cytometry after remission [ Time Frame: After remission, up to 1 month ]
  3. Miss1 plasmatic concentration after remission [ Time Frame: After remission, up to 1 month ]


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Ages Eligible for Study:   12 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All nephrotic patients from the participating centers
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

- Patients already treated with glucocorticoids and/or immunosuppressor


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03592030


Contacts
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Contact: Jean-Jacques Boffa, Professor 00 33 1 56 01 60 29 jean-jacques.boffa@aphp.fr

Locations
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France
Service de Néphrologie et Dialyses Paris, Hôpital Tenon Recruiting
Paris, France, 75020
Contact: Jean-Jacques BOFFA, Professor    00 33 1 56 01 60 29    jean-jacques.boffa@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Jean-Jacques Boffa, Professor Assistance Publique - Hôpitaux de Paris

Publications:
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03592030     History of Changes
Other Study ID Numbers: NI17036
First Posted: July 19, 2018    Key Record Dates
Last Update Posted: July 19, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Idiopathic nephrotic syndrome
Minimal change diseases
Primitive FSGS

Additional relevant MeSH terms:
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Syndrome
Nephrotic Syndrome
Nephrosis
Disease
Pathologic Processes
Kidney Diseases
Urologic Diseases