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

NCT02894606 | Unknown

• 1 other identifier: THYMO B (RB 13.072)
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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)

Conditions

Renal Transplant

Keywords

Kidney Transplant; Immunology

Outcome Measures

Primary Outcomes (2)

• The distribution of mature blood B cells subpopulations will be compared between the 2 groups

  one year after renal transplant

• Proliferation of freshly isolated cells T in presence of autologous B cells will be compared between the 2 groups.

  one year after renal transplant

Secondary Outcomes (1)

• Serum B-cell activating factor (BAFF) concentration comparison between the two groups

  one year after renal transplant

Study Arms (2)

Thymoglobulin Induction

Patient receiving thymoglobulin as an induction therapy for renal transplant

Drug: Thymoglobulin Induction

Basiliximab Induction

Patient receiving basiliximab as an induction therapy for renal transplant

Drug: Basiliximab Induction

Interventions

Thymoglobulin Induction DRUG

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.

Thymoglobulin Induction

Basiliximab Induction DRUG

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.

Basiliximab Induction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

kidney graft recipients from two French renal transplantation centers

You may qualify if:

• 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

You may not qualify if:

• Patient participating in a clinical trial

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (2)

CHU Brest

Brest, 29200, France

RECRUITING

Tours University Hospital

Tours, 37000, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

Study Officials

• Yannick Le meur

  University Hospital, Brest

  STUDY DIRECTOR

Central Study Contacts

Yannick LE MEUR, MD PhD

CONTACT

yannick.lemeur@chu-brest.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2016
• First Posted: September 9, 2016
• Study Start: February 1, 2015
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: September 9, 2016

Record last verified: 2016-09

Locations

FR (2)