ABOUT THIS STUDY
- Non-HLA identical living donor kidney transplant patients
- Patient has previously received or is receiving an organ transplant other than a
- Patient is receiving an ABO incompatible donor kidney.
- Recipient or donor is known seropositive for human immunodeficiency (HIV) or Hepatitis
C virus, or Hepatitis B virus antigenemia.
- 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
- 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 at our center.
- 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.
- Patient is currently participating in another clinical trial of an investigational
drug in the 30 days prior to transplant.
- Patient will be receiving any immunosuppressive agent other than those prescribed in
- 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).
- Patient is receiving or may require Warfarin, Fluvastatin, or herbal supplements
during the study.
- Concurrent use of Astemizole, Pimozide, Cisapride, Terfenadine, or Ketoconazole.
- Patient has a known hypersensitivity to Tacrolimus, Thymoglobulin®, IL-2 receptor
inhibitor monoclonal antibodies, Rapamune, Myfortic®, or corticosteroids.
- Patient is pregnant or lactating.
- 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 >200 mg/dl.
- Patient is unlikely to comply with the visits scheduled in the protocol.
- Patient has any form of substance abuse, psychiatric disorder or a condition that, in
the opinion of the investigator, may invalidate communication with the investigator.
- If Tacrolimus cannot be instituted for longer than 5 days postoperatively.
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