Protective Immunity Project 01

Completed

Conditions studied: Kidney Transplantation, Immunity, Immunosuppression

In brief

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.

Key facts

Study ID

NCT00788021

Run by

Emory University

People needed

124

Starts

2006-09-01

Expected to finish

2011-10-01

Last updated by the study team

2013-11-25

Who can join

Age: 18 and older, up to 59. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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). -

Where it is running

• Emory University — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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