NCT00714480|CompletedDMC
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Sponsor study identifier
interventional
3
1 country
1
Study Start
July 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2009
Actual (reported)Study Completion
December 2009
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2009
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2008
Date type not reportedThis date has not been verified as actual or estimated.
July 9, 2008
Actual (reported)July 14, 2008
Actual (reported)December 2009
Actual (reported)December 2009
Actual (reported)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
Administration of anti-thymocyte globulin post-operative days -6,-4,-2, and 0
Administration of anti-thymoglobulin post-operative days -2, 0, 2 and 4
Administration of anti-thymocyte globulin post-operative days 0, 2, 4 and 6
Administration of anti-thymocyte globulin at post-operative days -6, -4, -2 and 0
anti-thymocyte globulin post-operative days -2, 0, 2 and 4
Swedish Medical Center
Seattle, Washington, 98122, United States
William H Marks, MD PhD
Swedish Medical Center
Paul Warner, PhD
Bloodworks
3 participants (actual enrollment reported by the registry).
First Submitted
July 9, 2008
First Posted
July 14, 2008
Study Start
July 2008
Date type not reportedThis date has not been verified as actual or estimated.
Renal Transplantation With Immune Monitoring
Post-operative days 0, 2, 4 and 6
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Primary Completion
December 2009
Actual (reported)Study Completion
December 2009
Actual (reported)Last Updated
August 4, 2011
Record last verified: 2011-08
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Source: ClinicalTrials.gov.
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