IgA Nephropathy, Lymphocyte Homing and IgA Class Switch
NIDOCIGA
1 other identifier
interventional
72
1 country
1
Brief Summary
IgA nephropathy (IgAN) is the most common primary glomerulonephritis in the world and it represents an important cause of end-stage kidney failure. This disease was described as a distinct entity in 1968 by J Berger and N Hinglais. The aetiology and the pathogenesis remain still obscure. Clinical observations and immunisation studies indicate that IgAN represents a dysregulation of the immune system, rather than an intrinsic renal abnormality. Twenty years ago, some authors proposed the mucosa-bone marrow axis to explain the pathogenesis of the disease. Mucosal IgA plasmocytes are displaced and take up residence in systemic sites. The unusual characteristics featured by the IgA produced by these cells (charge, size, glycosylation) drive their accumulation, deposition and mesangial activation characteristic of IgAN. Evidence is emerging that altered lymphocyte homing may ultimately explain this aberrant localization.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2013
Longer than P75 for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
January 18, 2013
CompletedFirst Posted
Study publicly available on registry
January 25, 2013
CompletedStudy Start
First participant enrolled
February 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedAugust 22, 2016
November 1, 2012
1 year
January 18, 2013
August 19, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
The Primary Outcome Measure of this study is the level of expression of the molecules of intestinal localization.
30 minutes
Secondary Outcomes (1)
The secondary outcome measure is the level of expression of the homing molecules in lymphocytes B IgA memory
30 minutes
Study Arms (1)
blood test
OTHERInterventions
Eligibility Criteria
You may qualify if:
- Age \> 18 and \< 70 years
- Glomerular filtration rate (MDRD formula as simplified) \< 90 ml/mn and \> 30 ml/mn/1,73 m2
- Consent form signed
You may not qualify if:
- Patients with cirrhosis or chronic liver disease
- Patients with a history of Crohn's disease or celiac disease
- Patients who received treatment with corticosteroids or affiliates for six months
- Patients who received a live attenuated vaccine during the past 4 weeks
- Patients with a known infection such as HIV, hepatitis B or C
- Patients who presented with a serious infection during the last month
- Breastfeeding women
- Patients not affiliated with a social security scheme
- Under guardianship patient
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital, Limoges
Limoges, 87 042, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ahmed Boumediene, doctor
University Hospital, Limoges
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 18, 2013
First Posted
January 25, 2013
Study Start
February 1, 2013
Primary Completion
February 1, 2014
Study Completion
June 1, 2016
Last Updated
August 22, 2016
Record last verified: 2012-11