- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01775527
IgA Nephropathy, Lymphocyte Homing and IgA Class Switch (NIDOCIGA)
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.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Limoges, France, 87 042
- University Hospital, Limoges
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age > 18 and < 70 years
- IgA nephropathy documented by the kidney biopsy in the six months preceding the inclusion
- Glomerular filtration rate (MDRD formula as simplified) < 90 ml/mn and > 30 ml/mn/1,73 m2
- Consent form signed
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: blood test
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The Primary Outcome Measure of this study is the level of expression of the molecules of intestinal localization.
Time Frame: 30 minutes
|
30 minutes
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The secondary outcome measure is the level of expression of the homing molecules in lymphocytes B IgA memory
Time Frame: 30 minutes
|
30 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ahmed Boumediene, doctor, University Hospital, Limoges
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- I10 014
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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