Thymoglobulin Versus Campath-1H Versus Daclizumab in Adult, Primary Deceased Donor Renal Transplantation

Exclusion Criteria

• •1. Patient has previously received or is receiving an organ transplant other than a kidney.
• •2. Patient is receiving an ABO incompatible donor kidney.
• •3. Recipient or donor is seropositive for human immunodeficiency (HIV), or Hepatitis C viruses, or Hepatitis B virus antigenemia.
• •4. Patient has a current malignancy or a history of malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully, or carcinoma in situ of the cervix that has been treated successfully.
• •5. Patients with significant liver disease, defined as having during the past 28 days continuously elevated AST (SGOT) and/or ALT (SGPT) levels greater than 3 times the upper value of the normal range of this center.
• •6. Patient has uncontrolled concomitant infections and/or severe diarrhea, vomiting, active upper gastro-intestinal tract malabsorption or an active peptic ulcer or any other unstable medical condition that could interfere with study objectives.
• •7. Patient is currently participating in another clinical trial and/or is taking or has been taking an investigational drug in the 30 days prior to transplant.
• •8. Patient will be receiving any immunosuppressive agent other that those prescribed in the study.
• •9. Patient is unable to take medications orally or via nasogastric tube by the morning of the second day following completion of the transplant procedure (i.e. skin closure).
• •10. Patient is receiving or may require warfarin, fluvastatin or herbal supplements during the study.
• •11. Concurrent use of astemizole, pimozide, cisapride, terfenadine, or ketoconazole.
• •12. Patient has a known hypersensitivity to tacrolimus, campath 1H, Thymoglobulin, daclizumab (Zenapax), sirolimus, mycophenolate or corticosteroids.
• •13. Patient is pregnant or lactating.
• •14. Patients with a screening/baseline (or within 96 hours of transplant) total white blood cell count \< 4000/mm3; platelet count \< 100,000/mm3; fasting triglycerides \> 400 mg/dl (\> 4.6 mmol/L); fasting total cholesterol \> 300 mg/dl (\> 7.8 mmol/L); fasting HDL-cholesterol \< 30 mg/dl; fasting LDL-cholesterol \> 200mg/dl.
• •15. Patient is unlikely to comply with the visits scheduled in the protocol.
• •16. Patient has any form of substance abuse, psychiatric disorder or a condition that, in opinion of the investigator, may invalidate communication with the investigator.
• •17. If tacrolimus cannot be instituted for longer than 5 days postoperatively.