NCT02829164

Brief Summary

Primitive kidney disease IgA, represented by Berger's disease and rheumatoid purpura nephropathy, are the first cause of kidney failure from chronic glomerulonephritis: changes in 20 years to end-stage renal failure is described in 10 to 30 % of cases in Berger's disease and in 15 to 20% of cases in nephropathy HSP. These two pathological entities share biological and histological characteristics, as well as common pathophysiological mechanisms, particularly the production of abnormally glycosylated IgA1 promoting their proliferation in the mesangium. Tonsils part of Iga abnormal production sites that would be associated with an infectious stimulus, tonsillectomy has been studied as a possible treatment in primitive IgA nephropathy. The benefit of tonsillectomy is controversial: many Japanese studies demonstrate its effectiveness in terms of reduction of proteinuria, improved renal function in the long term regression of histological lesions and reduced risk of relapse following clinical remission whereas European studies do not suggest its effectiveness in treating IgA nephropathy. In this context, the aim of our study is to describe the scope of practice of tonsillectomy in the treatment of primary renal disease in IgA child in the inter East region and describe the short renal become Strasbourg end of the cohort that received this treatment.

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
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2016

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2016

Completed
26 days until next milestone

First Posted

Study publicly available on registry

July 12, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

May 23, 2017

Status Verified

May 1, 2017

Enrollment Period

1.4 years

First QC Date

June 16, 2016

Last Update Submit

May 19, 2017

Conditions

Keywords

Tonsillectomyprimary IgA nephropathyprimary nephropathyIgABerger's diseasePurpura rheumatoidkidney failure

Outcome Measures

Primary Outcomes (1)

  • Evaluation of the management of the tonsillectomy at the CHU of Strasbourg by a standardized questionnaire

    since January 2009

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children with a clinical diagnosis and / or histological evidence of primary IgA nephropathy

You may qualify if:

  • Children with a clinical diagnosis and / or histological evidence of primary IgA nephropathy
  • Follow the University Hospital of Strasbourg since 2009
  • Having received a tonsillectomy in their care
  • Children whose holders of parental authority does not oppose the use of clinical data from their child for research purposes

You may not qualify if:

  • Children whose holders of parental authority are opposed to the use of clinical data from their child for research purposes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Pédiatrie 1 Hôpital de Hautepierre

Strasbourg, 67098, France

RECRUITING

MeSH Terms

Conditions

Glomerulonephritis, IGAIgA VasculitisRenal Insufficiency

Condition Hierarchy (Ancestors)

GlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAutoimmune DiseasesImmune System DiseasesVasculitisVascular DiseasesCardiovascular DiseasesPurpuraBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemostatic DisordersHemorrhagic DisordersSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesImmune Complex DiseasesHypersensitivityHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and Symptoms

Study Officials

  • Laetitia HIGEL, MD

    University Hospital, Strasbourg, France

    STUDY DIRECTOR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

June 16, 2016

First Posted

July 12, 2016

Study Start

April 1, 2016

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

May 23, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations