- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02829164
Tonsillectomy and Primitive IgA Nephropathy in Children: Strasbourg Cohort and Assessment Practices in Inter North East Region
May 19, 2017 updated by: University Hospital, Strasbourg, France
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.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Laetitia HIGEL, MD
- Phone Number: 33 (0)3.88.12.77.40
- Email: laetitia.higel@chru-strasbourg.fr
Study Contact Backup
- Name: Eléonore FEUGEAS, MD
- Phone Number: 33 (0)3.88.12.77.40
- Email: Eleonore.feugeas@chru-strasbourg.fr
Study Locations
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-
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Strasbourg, France, 67098
- Recruiting
- Service de Pédiatrie 1 Hôpital de Hautepierre
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Sub-Investigator:
- Eléonore FEUGEAS, MD
-
Contact:
- Laetitia HIGEL, MD
- Phone Number: 33 (0)3.88.12.77.40
- Email: laetitia.higel@chru-strasbourg.fr
-
Contact:
- Eléonore FEUGEAS, MD
- Phone Number: 33 (0)3.88.12.77.40
- Email: Eleonore.feugeas@chru-strasbourg.fr
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Principal Investigator:
- Laetitia HIGEL, MD
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Children with a clinical diagnosis and / or histological evidence of primary IgA nephropathy
Description
Inclusion criteria:
- 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
Exclusion criteria:
- Children whose holders of parental authority are opposed to the use of clinical data from their child for research purposes
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evaluation of the management of the tonsillectomy at the CHU of Strasbourg by a standardized questionnaire
Time Frame: since January 2009
|
since January 2009
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Laetitia HIGEL, MD, University Hospital, Strasbourg, France
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2016
Primary Completion (Anticipated)
September 1, 2017
Study Completion (Anticipated)
September 1, 2017
Study Registration Dates
First Submitted
June 16, 2016
First Submitted That Met QC Criteria
July 7, 2016
First Posted (Estimate)
July 12, 2016
Study Record Updates
Last Update Posted (Actual)
May 23, 2017
Last Update Submitted That Met QC Criteria
May 19, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6402
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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