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Thymoglobulin: Presence and Affect in the Central Lymphatic Compartment

NCT00714480 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2011-08-04

No results posted yet for this study

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

Interventions

DRUG

anti-thymocyte globulin

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

DRUG

anti-thymocyte globulin

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

DRUG

anti-thymocyte globulin

Post-operative days 0, 2, 4 and 6

Sponsors & Collaborators

  • Genzyme, a Sanofi Company

    collaborator INDUSTRY

  • Swedish Medical Center

    lead OTHER

Principal Investigators

  • William H Marks, MD PhD · Swedish Medical Center

  • Paul Warner, PhD · Bloodworks

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00714480 on ClinicalTrials.gov