IgA Nephropathy, Lymphocyte Homing and IgA Class Switch (NIDOCIGA)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
IgA Nephropathy |
Other: blood test |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | IgA Nephropathy, Lymphocyte Homing and IgA Class Switch |
- The Primary Outcome Measure of this study is the level of expression of the molecules of intestinal localization. [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
- The secondary outcome measure is the level of expression of the homing molecules in lymphocytes B IgA memory [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 72 |
| Study Start Date: | February 2013 |
| Estimated Study Completion Date: | July 2014 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| blood test | Other: blood test |
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| France | |
| University Hospital, Limoges | Recruiting |
| Limoges, France, 87 042 | |
| Contact: Ahmed BOUMEDIENE, MD 05 55 05 11 40 ahmed.boumediene@chu-limoges.fr | |
| Principal Investigator: Ahmed BOUMEDIENE, MD | |
| Principal Investigator: | Ahmed Boumediene, doctor | University Hospital, Limoges |
More Information
No publications provided
| Responsible Party: | University Hospital, Limoges |
| ClinicalTrials.gov Identifier: | NCT01775527 History of Changes |
| Other Study ID Numbers: | I10 014 |
| Study First Received: | January 18, 2013 |
| Last Updated: | March 26, 2013 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Additional relevant MeSH terms:
|
Glomerulonephritis, IGA Kidney Diseases Glomerulonephritis Nephritis |
Urologic Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013