NCT03592030

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

July 9, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 19, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

July 19, 2018

Status Verified

June 1, 2018

Enrollment Period

2.8 years

First QC Date

July 9, 2018

Last Update Submit

July 9, 2018

Conditions

Nephrotic Syndrome

Keywords

Idiopathic nephrotic syndromeMinimal change diseasesPrimitive FSGS

Outcome Measures

Primary Outcomes (1)

  • 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.

    From Day 0 to 1 month

Secondary Outcomes (3)

  • Miss1 plasmatic concentration at the time of the diagnostic of nephrotic syndrome

    From Day 0 to 1 month

  • Miss1 expression in circulating blood cells on flow cytometry after remission

    After remission, up to 1 month

  • Miss1 plasmatic concentration after remission

    After remission, up to 1 month

Eligibility Criteria

Age12 Months+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All nephrotic patients from the participating centers

You may qualify if:

  • 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

You may not qualify if:

  • \- Patients already treated with glucocorticoids and/or immunosuppressor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Néphrologie et Dialyses Paris, Hôpital Tenon

Paris, 75020, France

RECRUITING

Related Publications (3)

  • 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.

    PMID: 4140273BACKGROUND

  • Eddy AA, Symons JM. Nephrotic syndrome in childhood. Lancet. 2003 Aug 23;362(9384):629-39. doi: 10.1016/S0140-6736(03)14184-0.

    PMID: 12944064BACKGROUND

  • van 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.

    PMID: 15157184BACKGROUND

MeSH Terms

Conditions

Nephrotic SyndromeNephrosis, Lipoid

Condition Hierarchy (Ancestors)

NephrosisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Jean-Jacques Boffa, Professor

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Jacques Boffa, Professor

CONTACT

00 33 1 56 01 60 29jean-jacques.boffa@aphp.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2018

First Posted

July 19, 2018

Study Start

January 1, 2016

Primary Completion

October 1, 2018

Study Completion

December 1, 2018

Last Updated

July 19, 2018

Record last verified: 2018-06

Locations

FR(1)