NCT01775527

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 25, 2013

Completed
7 days until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

August 22, 2016

Status Verified

November 1, 2012

Enrollment Period

1 year

First QC Date

January 18, 2013

Last Update Submit

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

OTHER
Other: blood test

Interventions

blood test

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Glomerulonephritis, IGA

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

GlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Ahmed Boumediene, doctor

    University Hospital, Limoges

    PRINCIPAL INVESTIGATOR

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

Locations