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Sponsored by: |
Emory University |
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Information provided by: | Emory University |
ClinicalTrials.gov Identifier: | NCT00788021 |
Patients who undergo kidney transplant must take medications to prevent organ rejection. There are standard immunosuppressant medications such as prednisone, tacrolimus (Prograf), mycophenolate mofetil(Cellcept) or sirolimus (Rapamune) that are given to patients to prevent rejection. It is well known that patients on immunosuppressant medications are at increased risk from viral infections, such as influenza. However, it is not well understood how immunosuppressive medications may uniquely affect the immune response to infection. This study will determine whether there are unique differences in the effects on the immune system by these different immunosuppressive medications, particularly differences between tacrolimus and sirolimus.
Condition |
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Kidney Transplantation Immunity Immunosuppression |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Characterization of the Impact of Chronic Immunosuppressive Regimens on Protective Immunity Over Time in Renal Transplant Recipients |
Whole blood, serum, PBMCs
Estimated Enrollment: | 120 |
Study Start Date: | September 2006 |
Estimated Study Completion Date: | November 2010 |
Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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Tacrolimus
Recipients of deceased or living donor renal transplant maintained on immunosuppressive regimen utilizing tacrolimus
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Sirolimus
Recipients of deceased or living donor renal transplants maintained on immunosuppressive regimen using sirolimus
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Healthy controls
Age, race and gender-matched individuals not on immunosuppressive regimens. Whenever possible an transplant recipient's donor may be recruited to serve as healthy control
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While the benefits of transplantation to society are substantial, the ever-growing population of immunosuppressed recipients poses a unique challenge in development of immunization and containment strategies to protect the population from communicable pathogens and weaponized infectious agents. The immunosuppressive regimens that have allowed the emergence of successful transplant therapy not only inhibit T cell-dependent rejection but also cause systemic immunosuppression, which attenuates the response to vaccines in general and precludes the use of live attenuated vaccines. To date, there has been relatively little detailed systematic study of the immune alterations that accompany either the short- or long-term immunosuppressive regimens used in clinical organ transplantation. Despite the recent development of increasingly effective, but also increasingly complex, regimens using drugs with very distinct molecular targets, current policies on vaccination of transplant recipients are generic and remain based on old concepts rather than on any new understanding of the cellular and molecular effects of these therapies on the human immune system. This proposal seeks to improve our understanding of the biological mechanisms that underlie the distinct immunosuppressive regimens in practice today (calcineurin-inhibitor, or CNI, and sirolimus-based regimens) and in emerging regimens that employ agents with novel mechanisms of action, such as the CD28 costimulation blockers, and/or JAK3 kinase inhibitors. Such knowledge will be critical to strategies for enhancing desirable immune responses while not precipitating rejection.
Ages Eligible for Study: | 18 Years to 59 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Patients undergoing deceased or living donor renal transplant
Inclusion Criteria:
Exclusion Criteria:
Contact: Rivka S. Elbein, RN | 404-712-1114 | rivka.elbein@emoryhealthcare.org |
Contact: Beth Begley, RN | 404-712-1114 | beth.begley@emoryhealthcare.org |
United States, Georgia | |
Emory University | Recruiting |
Atlanta, Georgia, United States, 30322 |
Principal Investigator: | Christian P. Larsen, MD, DPhil | Emory University |
Principal Investigator: | Kenneth E. Kokko, MD, PhD | Emory University |
Responsible Party: | Emory University ( Christian P. Larsen, MD, DPhil ) |
Study ID Numbers: | PIP-01 |
Study First Received: | November 7, 2008 |
Last Updated: | November 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00788021 |
Health Authority: | United States: Institutional Review Board |
Transplant Immunity Immunosuppression |