Sirolimus and Thymoglobulin to Prevent Kidney Transplant Rejection
Kidney Failure
About this trial
This is an interventional treatment trial for Kidney Failure focused on measuring Renal Failure, Anti-rejection, Apoptosis, Polyclonal Antibody, Kidney Transplant
Eligibility Criteria
INCLUSION CRITERIA: Candidates for a kidney transplant performed at the NIH Clinical Center. Willingness and legal ability to give informed consent. Availability of donor tissue for testing. This could include splenic or peripheral blood lymphocytes from a cadaveric donor or a willing living donor enrolled on the Clinical Center Living Donor Protocol who consents to periodic phlebotomy for peripheral blood lymphocyte isolation. EXCLUSION CRITERIA: Immunosuppressive drug therapy at the time of or 2 months prior to enrollment. Specifically, candidates may not be taking prednisone, cyclosporine, tacrolimus, azathioprine, mycophenolate mofetil, anti-lymphocyte agents, cyclophosphamide, methotrexate, or other agents whose therapeutic effect is immunosuppressive. Any active malignancy or any history of a hematogenous malignancy or lymphoma. Patients with primary, cutaneous basal cell or squamous cell cancers may be enrolled providing the lesions are appropriately treated prior to transplant. Significant coagulopathy or requirement for anticoagulation therapy that would contraindicate protocol allograft biopsies. Platelet count less than 100,000/mm(3). Any known immunodeficiency syndrome. Any history of cardiac insufficiency, major vascular disease, symptomatic coronary artery disease. Systemic or pulmonary edema. Inability to be effectively dialyzed. Any condition that would likely increase the risk of protocol participation or confound the interpretation of the data. Any history of sensitization to rabbits or extensive exposure to rabbits. Inability or unwillingness to comply with protocol monitoring and therapy, including, among others, a history of noncompliance, circumstances where compliance with protocol requirements is not feasible due to living conditions, travel restrictions, access to urgent medical services, or access to anti-rejection drugs after the research protocol is completed.
Sites / Locations
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Arms of the Study
Arm 1
Experimental
Sirolimus and Thymoglobulin
Thymoglobulin (Sangstat), a FDA-approved polyclonal rabbit-IgG antithymocyte preparation, will be given for ten days at the time of transplantation to achieve profound lymphocyte depletion. This will be paired with chronic therapy with Sirolimus (rapamycin, Wyeth-Ayerst), an oral immunosuppressant agent recently approved by the FDA.