Please select the eligibility criteria that correspond to the clinical trial below.
Title: Phase 4, Randomized, Open-label, Comparative, Multicenter Study to Assess the Safety and Efficacy of Induction Agents, Alemtuzumab, Basiliximab or Rabbit Anti-thymocyte Globulin in Combination With Tacrolimus, MMF, and a Rapid Steroid Withdrawal in Renal Transplant Recipients
Brief Summary: The purpose of this study is to compare the safety and efficacy of different induction agents (alemtuzumab, basiliximab or rabbit anti-thymocyte globulin) in renal transplant recipients treated with tacrolimus, mycophenolate mofetil (MMF) and a rapid steroid withdrawal.


Options:
A: Inclusion Criteria:

* Primary renal transplant recipient for end-stage renal disease

Exclusion Criteria:

* Recipient age \< 18 years or \> 65 years
* Previous history of CMV disease
* Hepatitis B and C recipients
* Primary disease states that require steroids for immunosuppression
* Re-transplant with immunological cause of renal or pancreas loss
* Non heart beating donors
* Recipient of pediatric en bloc kidneys
* Recipient with a Panel Reactive Antibody (PRA) score \>75%
* Patients who have received 3 or more prior transplants, excluding pancreas
* Patients who are past recipients of other solid organ transplants
* Previous history of BK virus
* Previous treatment with Thymoglobulin
* Allergy to rabbits
* Simultaneous Kidney/Pancreas transplantation
B: Inclusion Criteria:

* Recipient of a primary or re-transplanted deceased donor kidney or a primary or re-transplanted non-human leukocyte antigen (HLA) living donor kidney (ie., HLA identical or 0 antigen mismatch deceased donor kidneys are allowed).

Exclusion Criteria:

* Patient has previously received an organ transplant other than a kidney
* Patient receiving chronic steroid therapy at time of transplant
C: Inclusion Criteria:

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 cadaver renal allograft
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.

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.
D: Inclusion Criteria:

* age 18-65
* endstage renal failure with no previous renal transplantation
* cadaveric donor
* written informed consent

Exclusion Criteria:

* pregnant or nursing women
* multi-organ transplant recipients
* live donor recipients
* re-transplants
* panel reactive antibodies (PRA) \> 25%
* previous treatment with Campath-1H
* use of other investigational agents within 6 weeks
* active systemic infection
* HIV positive patient or donor
* positive lymphocyte cytotoxicity cross-match between recipient serum and donor cells
* past history of anaphylaxis following exposure to humanized monoclonal antibodies

Answer: B