IgA Nephropathy, Lymphocyte Homing and IgA Class Switch

IgA Nephropathy Clinical Trial

— NIDOCIGA  

Official title:

IgA Nephropathy, Lymphocyte Homing and IgA Class Switch

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01775527
• Other study ID #: I10 014
• Status: Completed
• Phase: N/A
• First received: January 18, 2013
• Last updated: August 19, 2016
• Start date: February 2013
• Est. completion date: June 2016

Study information

• Verified date: November 2012
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: June 2016
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Glomerulonephritis, IGA
• IgA Nephropathy
• Kidney Diseases

Intervention

Other:
• blood test

Locations

Country	Name	City	State
France	University Hospital, Limoges	Limoges

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Primary Outcome Measure of this study is the level of expression of the molecules of intestinal localization.		30 minutes	No
Secondary	The secondary outcome measure is the level of expression of the homing molecules in lymphocytes B IgA memory		30 minutes	No