Status:
COMPLETED
Protective Immunity Project 01
Lead Sponsor:
Emory University
Conditions:
Kidney Transplantation
Immunity
Eligibility:
All Genders
18-59 years
Brief Summary
Patients who undergo kidney transplant must take medications to prevent organ rejection. There are standard immunosuppressant medications such as prednisone, tacrolimus (Prograf), mycophenolate mofeti...
Detailed Description
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 str...
Eligibility Criteria
Inclusion
- Male or female patients between 18 and 59 years of age
- Patients capable of understanding the purposes and risks of the study, who can give written informed consent and who are willing to participate in and comply with the study.
- Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to enrollment and must not be breast-feeding.
Exclusion
- Patients with any prior organ transplant or multi-organ transplant recipients
- Patients that require induction immunosuppression beyond the immunosuppressive regimen proposed in this study. For example, patients that receive anti-lymphocyte antibody therapy or plasmapheresis as a result of pre-formed immunologic reactivity to the transplanted organ.
- Patients with evidence of an active systemic infection requiring the continued use of antibiotics, evidence of an HIV infection, or the presence of a chronic active hepatitis B or C.
- Patients with history of malignancy in the last 5 years (except successfully treated localized non-melanotic skin cancer)
- Patients with severe anemia (hemoglobin \< 8 g/dL), leukopenia (WBC \< 3000/mm3). -
Key Trial Info
Start Date :
September 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT00788021
Start Date
September 1 2006
End Date
October 1 2011
Last Update
November 25 2013
Active Locations (1)
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1
Emory University
Atlanta, Georgia, United States, 30322