Role of Regulatory T Cells in Pathogenesis of Primary IgA Nephropathy

Glomerulonephritis, IGA Clinical Trial

Official title:

Role of CD4+CD25+FoxP3+ Regulatory T Cells in Pathogenesis of Primary IgA Nephropathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00521508
• Other study ID #: 0608118
• Secondary ID: 2007-A00129-44DG
• Status: Completed
• Phase: N/A
• First received: August 27, 2007
• Last updated: September 28, 2010
• Start date: April 2008
• Est. completion date: September 2010

Study information

• Verified date: September 2010
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: French Data Protection Authority
• Study type: Interventional

Clinical Trial Summary

Along structural IgA abnormalities, hyperproduction of IgA is thought to play a role in the pathogenesis of primary IgA nephropathy. CD4+CD25+Fox3P regulatory T cells are instrumental in suppressing adaptative immune responses, including B cells production of immunoglobulins. We, the researchers at Centre Hospitalier Universitaire de Saine Etienne, will test the hypothesis that IgA production in patients with IgA nephropathy is dysregulated because of a quantitative and/or qualitative defect of CD4+CD25+FoxP3+ regulatory T cells.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: September 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients with pathogenesis of Berger's disease confirmed by renal biopsy

• Glomerular filtration > 60 ml/min/1,73m2

• Written informed consent

• Patient affiliated to social insurance

Exclusion Criteria:

• Immunosuppressor treatment within 6 months before the study inclusion

• Clinical infection within 2 months before the study inclusion

• C-reactive protein (CRP) > 10 mgL-1

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Glomerulonephritis
• Glomerulonephritis, IGA

Intervention

Procedure:
• gene transcription and cytometry
samply of 30 ml of blood

Locations

Country	Name	City	State
France	Nephrology Unit Hôpital Nord CHU de Saint-Etienne	Saint-Etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

References & Publications (3)

Laville M, Alamartine E. Treatment options for IgA nephropathy in adults: a proposal for evidence-based strategy. Nephrol Dial Transplant. 2004 Aug;19(8):1947-51. Epub 2004 May 25. — View Citation

Mariat C Degauque N et al. TIM-1 strengthens Th-1 polarization and weakens CD4+CD25 T cells. Am J Transplant 6(suppl 2): 557, 2006

Mariat C, Sánchez-Fueyo A, Alexopoulos SP, Kenny J, Strom TB, Zheng XX. Regulation of T cell dependent immune responses by TIM family members. Philos Trans R Soc Lond B Biol Sci. 2005 Sep 29;360(1461):1681-5. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proportion averages of cells CD4+CD25+CD127 low T in peripheral blood		inclusion	No
Secondary	average relative expression of genes FoxP3, CTLA4, GITR, IL10, TGF-B, OX40, TIM-1, and TIM-3		inclusion	No