Head-to-Head Comparison of Thymoglobulin vs. Campath-1H vs. Our Standard Center Treatment Protocol in Living Donor Renal Transplantation - A Study to Evaluate the Avoidance of Long-Term Nephrotoxic Calcineurin Inhibitor Therapy
1. Patient has been fully informed and has signed a dated IRB approval informed consent
form and is willing to follow study procedures for the extent of the study (36
months). Parent or legal guardian must provide written consent for patients <18
years of age.
2. Age 16-65 years
3. Weight > 40 kg
4. Primary renal allograft: living related (non HLA identical) and unrelated donor
5. Negative standard cross-match for T-cells. All donor-recipient pairs matched for a
minimum of 1 HLA DR antigen. (Standard at our center)
6. Women of childbearing potential will be required to have a negative qualitative serum
pregnancy test and agree to use an adequate method of contraception for 3 months
following discontinuation of Thymoglobulin or Campath-1H
7. Males and females are to be studied equivalently as they become available for
transplantation using these criteria.
1. Patient has previously received or is receiving an organ transplant other than a
2. Patient is receiving an ABO incompatible donor kidney.
3. Recipient or donor is seropositive for human immunodeficiency virus (HIV), 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
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 of an investigational
drug in the 30 days prior to transplant.
8. Patient will be receiving any immunosuppressive agent other that those prescribed in
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
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, MMF 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.