Status:
COMPLETED
Thymoglobulin: Presence and Affect in the Central Lymphatic Compartment
Lead Sponsor:
Swedish Medical Center
Collaborating Sponsors:
Genzyme, a Sanofi Company
Conditions:
Renal Transplantation
Immunosuppression
Eligibility:
All Genders
18+ years
Phase:
NA
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 a...
Detailed Description
Polyclonal anti-thymocyte globulins are used with increasing frequency to induce immunosuppression in organ transplant recipients. Induction therapy is used for the majority of persons receiving kidne...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00714480
Start Date
July 1 2008
End Date
December 1 2009
Last Update
August 4 2011
Active Locations (1)
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1
Swedish Medical Center
Seattle, Washington, United States, 98122