Influence of Thymoglobuline on Phenotypic and Functional Profiles of B Lymphocytes in Renal Transplant Recipients

Renal Transplant Clinical Trial

— THYMO B  

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02894606
• Other study ID #: THYMO B (RB 13.072)
• Status: Recruiting
• Phase: N/A
• First received: August 30, 2016
• Last updated: September 8, 2016
• Start date: February 2015
• Est. completion date: February 2018

Study information

• Verified date: September 2016
• Source: University Hospital, Brest
• Contact: Yannick LE MEUR, MD PhD
• Email: yannick.lemeur[@]chu-brest.fr
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertésFrance: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéFrance: Ministère de l'Enseignement supérieur et de la Recherche
• Study type: Observational

Clinical Trial Summary

The investigators expect to better characterise B cell subpopulation and functional properties early after graft, to analyse effect of induction therapy (thymoglobulin versus basiliximab) on B cells, and to compare this B cell profiles with those obtained in our previous study in patients with chronic Antibody Mediated Rejection (cAMR)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age >18 years old

• Recipient of a renal allograft

• Patient receiving either basiliximab or thymoglobulin as in induction therapy for renal transplant

• Patient presenting a low immunologic risk

• Patient not opposed to his (her) study participation

Exclusion Criteria:

• Patient participating in a clinical trial

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Renal Transplant

Intervention

Drug:
• Thymoglobulin Induction
The choice of the induction therapy is not a procedure of the study. This choice is made by the practioner, based on the graft recipient profile. This is a predefined group, the Thymoglobulin treatment is not an intervention in the study but must be considered as an exposure that is defined before the patient enters the study.
• Basiliximab Induction
The choice of the induction therapy is not a procedure of the study. This choice is made by the practioner, based on the graft recipient profile. This is a predefined group, the Basiliximab treatment is not an intervention in the study but must be considered as an exposure that is defined before the patient enters the study.

Locations

Country	Name	City	State
France	CHU Brest	Brest
France	Tours University Hospital	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The distribution of mature blood B cells subpopulations will be compared between the 2 groups		one year after renal transplant	No
Primary	Proliferation of freshly isolated cells T in presence of autologous B cells will be compared between the 2 groups.		one year after renal transplant	No
Secondary	Serum B-cell activating factor (BAFF) concentration comparison between the two groups		one year after renal transplant	No