Thymoglobulin: Presence and Affect in the Central Lymphatic Compartment

NCT00714480 | Completed DMC

• 1 other identifier: TMG 617
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Renal Transplantation; Immunosuppression

Keywords

Thymoglobulin; Renal Transplant; Kidney Transplant; Immunosuppression; Induction therapy

Outcome Measures

Primary Outcomes (1)

• The primary objectives of this pilot study are to examine lymphocyte marker expression, quantitate specific lymphocyte subsets and apoptosis, and assess immune function in subjects receiving TMG.

  Pretransplant days -6, -4, -2, 0; Post-transplant days 2, 4, 6

Study Arms (3)

Group I

OTHER

Administration of anti-thymocyte globulin post-operative days -6,-4,-2, and 0

Drug: anti-thymocyte globulin

Group II

OTHER

Administration of anti-thymoglobulin post-operative days -2, 0, 2 and 4

Drug: anti-thymocyte globulin

Group III

OTHER

Administration of anti-thymocyte globulin post-operative days 0, 2, 4 and 6

Drug: anti-thymocyte globulin

Interventions

anti-thymocyte globulin DRUG

Administration of anti-thymocyte globulin at post-operative days -6, -4, -2 and 0

Also known as: Thymoglobulin

Group I

Eligibility Criteria

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

You may qualify if:

• All subjects age 18 years or older who qualify to receive a living (related or unrelated) kidney allograft using steroid free induction immunosuppression.
• Single organ recipient (kidney only)
• Subjects receiving first renal transplant
• Women of childbearing potential should have a negative serum pregnancy test within 1 week prior to beginning study medications
• Subjects with no prior history of immunosuppression
• Subjects with no systemic illness (i.e. diabetes, autoimmune disease)
• Subjects with negative serologies (Hep B, Hep C, HIV)
• Subjects who are candidates for TMG induction
• Subjects providing written consent
• Subjects who are compliant and able to complete all the assessment procedures

You may not qualify if:

• Subjects less than 18 years of age
• Subjects who do not meet criteria for steroid free protocol
• Subjects who are pregnant, lactating or nursing
• Child bearing women not willing to use a reliable form of contraception
• Subjects with a known allergy to rabbits or rabbit products
• Subjects receiving other medications considered to be experimental

Sponsors & Collaborators

• Swedish Medical Center: lead
• Genzyme, a Sanofi Company: collaborator

Study Sites (1)

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

MeSH Terms

Interventions

Antilymphocyte Serum; thymoglobulin

Intervention Hierarchy (Ancestors)

Immune Sera; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Biological Products; Complex Mixtures

Study Officials

• William H Marks, MD PhD

  Swedish Medical Center

  PRINCIPAL INVESTIGATOR

• Paul Warner, PhD

  Bloodworks

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 9, 2008
• First Posted: July 14, 2008
• Study Start: July 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: August 4, 2011

Record last verified: 2011-08

Locations

US (1)