Thymoglobulin: Presence and Affect in the Central Lymphatic Compartment

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study proposes to examine the effect of TMG therapy upon the cellular elements within the central (bone marrow) and peripheral (lymph node) lymphoid compartments of humans. Briefly, bone marrow aspirates and lymph nodes will be obtained at the time of transplant, from renal transplant recipients receiving TMG induction therapy. For comparative purposes, peripheral blood samples will also be obtained. Lymphocytes from these compartments will be assessed for CD antigen expression, apoptosis, cytokine production following memory immune responses, and functional assays to assess potential regulatory T-cell (Treg) activity.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Swedish Medical Center
• Collaborator: Genzyme, a Sanofi Company
• Treatments: Antilymphocyte Serum; Thymoglobulin

Criteria

Inclusion Criteria:

1. All subjects age 18 years or older who qualify to receive a living (related or unrelated) kidney allograft using steroid free induction immunosuppression.

2. Single organ recipient (kidney only)

3. Subjects receiving first renal transplant

4. Women of childbearing potential should have a negative serum pregnancy test within 1 week prior to beginning study medications

5. Subjects with no prior history of immunosuppression

6. Subjects with no systemic illness (i.e. diabetes, autoimmune disease)

7. Subjects with negative serologies (Hep B, Hep C, HIV)

8. Subjects who are candidates for TMG induction

9. Subjects providing written consent

10. Subjects who are compliant and able to complete all the assessment procedures

Exclusion Criteria:

1. Subjects less than 18 years of age

2. Subjects who do not meet criteria for steroid free protocol

3. Subjects who are pregnant, lactating or nursing

4. Child bearing women not willing to use a reliable form of contraception

5. Subjects with a known allergy to rabbits or rabbit products

6. Subjects receiving other medications considered to be experimental