Effect of Thymoglobulin Versus Basiliximab on Regulatory T Cell Function in Live Donor Kidney Transplant Recipients
NCT ID: NCT02730715
Last Updated: 2022-09-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
30 participants
OBSERVATIONAL
2010-11-30
2020-04-30
Brief Summary
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Detailed Description
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T cell depletion by antibody has become standard of care in the majority of renal transplant programs in the country (including Penn) and this may have reduced short term acute rejection episodes within the first year of transplant. There have unfortunately not been corresponding improvements in long term outcomes and, in fact, the average half life of a renal graft is minimally changed in 2010 compared to 1995. This has been attributed to unresolved issues in diagnosing and treating what is described as "chronic allograft nephropathy" - which in real terms, is probably a longstanding chronic rejection that may be in part due to a mixed T and B cell antigraft response. Despite the fact that these agents are used regularly in clinical transplantation, little is known about their effects on regulatory T cell (Treg) numbers and suppressive activity and nothing is known about effects on the methylation status of Tregs, which seems to correlate with their function. These are novel questions that are a) relevant to clinical practice since these agents are being used in renal transplantation already, b) may yield information that could alter best practices, and c) will yield more basic information about Tregs in human transplantation that will be relevant to future study. There have been few papers that have looked predominantly at a few immunosuppressive agents and numbers of Tregs (this is a low quality statistic since the markers of Tregs are shared by other cell types and thus the "numbers" can be hard to interpret) but little about function or methylation. The investigators propose to randomize 30 live donor kidney recipients to receive either thymoglobulin or basiliximab immunosuppression and thereafter receive standard of care maintenance immunosuppression determined by the clinical team. Both of these regimens are used as standard of care in this hospital. The investigators will enroll only patients with low immunological risk (0-10% PRA) and who are receiving an Blood Type (ABO) compatible transplant. After the initial randomization, all further decisions regarding immunosuppression will be made by the clinical team independent of the study. The investigators will draw blood samples pre-transplant, 3 months after transplant, and 6 months and 12 months after transplant.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Thymoglobulin
blood specimen collection
Thymoglobulin
Periodic blood collection to monitor Treg cells
Basiliximab
blood specimen collection
Basiliximab
Periodic blood collection to monitor Treg cells
Interventions
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Basiliximab
Periodic blood collection to monitor Treg cells
Thymoglobulin
Periodic blood collection to monitor Treg cells
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
70 Years
ALL
No
Sponsors
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University of Pennsylvania
OTHER
Responsible Party
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Principal Investigators
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Matthew L Levine, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Locations
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University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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811893
Identifier Type: -
Identifier Source: org_study_id
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