Effectiveness of the Investigational Drug Campath-1H in Preventing Rejection of Transplanted Kidneys
Graft Rejection, Kidney Disease
About this trial
This is an interventional treatment trial for Graft Rejection focused on measuring Immunosuppression, Tolerance, DSG, Alemtuzumab
Eligibility Criteria
INCLUSION CRITERIA: Candidates for a kidney transplant performed at the Warren G. Magnuson Clinical Center. Willingness and legal ability to give informed consent, or permission from a legal guardian. Willingness to travel to the Clinical Center for protocol specific samples to be taken, or in some cases, the ability to send samples via overnight mail. 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 Clinic 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 must not be taking prednisone, cyclosporine, tacrolimus, azathioprine, mycophenolate mofetil, antilymphocyte agents, cyclophosphamide, methotrexate, or other agents whose therapeutic effect is immunosuppressive. Any condition that precludes serial follow-up. 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). Hemoglobin less than 9.0 mg/dl. Patients may be on erythropoietin therapy, but will not be placed on therapy solely to facilitate research sample acquisition. Any known immunodeficiency syndrome. HLA identical status with a living donor. Any history of uncompensated cardiac insufficiency, major vascular disease, or symptomatic coronary artery disease. Systemic or pulmonary edema. Inability to be effectively dialyzed. Chronic hypotension (SBP less than 100 mmHg). Any condition that would likely increase the risk of protocol participation or confound the interpretation of the data. CMV negative status receiving an organ from a known CMV positive donor. EBV negative status receiving an organ from a known EBV positive donor. Panel reactive antibody greater than 20% due to HLA antibodies.
Sites / Locations
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Arms of the Study
Arm 1
Experimental
Alemtuzumab and DSG
The recipients of live donor kidneys were treated perioperatively with alemtuzumab and DSG and followed postoperatively without maintenance immunosuppression.