Please select the eligibility criteria that correspond to the clinical trial below.
Title: An Open-Label Prospective, Randomized, Multicenter Phase II Comparative Trial of Thymoglobulin® Versus Simulect® for the Prevention of Delayed Graft Function and Acute Allograft Rejection in Renal Allograft Recipients
Brief Summary: A multicenter clinical study comparing event-free survival at 6 months after transplant between Thymoglobulin-treated and Simulect-treated adult kidney transplant patients. Patients received Thymoglobulin or Simulect from Day 0 through Day 4. Day 0 was considered the day of the transplant procedure.

Subjects meeting all inclusion and exclusion criteria were eligible to participate in this study. The treatment assignment was random and not chosen by the subject or their physician.

Subjects were monitored during treatment with Thymoglobulin and during the transplant hospitalization. Additional subject monitoring occurred up to 12 months after transplant.

278 study subjects were enrolled at 28 transplant centers in the United States and Europe.


Options:
A: Inclusion Criteria:

* Patient greater than or equal to 18 years old.
* Patient is classified as "high risk" for acute allograft rejection of DGF. Must have had at least 1 donor or 1 recipient variable for high risk.
* Patient will be a recipient of a solitary cadaveric renal allograft.
* Women of childbearing potential must have had a negative pregnancy test (serum or urine).
* Man or woman agrees to practice medically acceptable contraception (i.e. barrier or pharmacologic) for a minimum of 3 months following study drug administration. In addition, women were recommended to practice contraception for 1 year following transplantation, or per local standard.
* Patient agrees to participate in the study and sign an informed consent.
* Patient has no known contraindication to the administration of rabbit anti-thymocyte globulin or basiliximab. Patient has no history of hypersensitivity to basiliximab.
* Patient is dialysis-dependent at the time immediately prior to transplantation.

Exclusion Criteria:

* Patient has received an investigational medication within the past 30 days.
* Patient has a history of malignancy within 2 years, with the exception of adequately treated localized squamous basal cell carcinoma of the skin without evidence of recurrence.
* Patient is currently abusing drugs or alcohol.
* Patient is known or suspected to have an active infection or be seropositive for hepatitis B surface antigen (HBsAg), hepatitis C (HCV), or human immunodeficiency virus (HIV).
* Patient is a multiple organ transplant recipient.
* Patient is on any type of immunosuppression (i.e. prior transplant recipient still on immunosuppression, or patient is receiving systemic steroids for any medical condition).
* Patient, who, in the opinion of the investigator, has significant medical or psychosocial problems or unstable disease states which would preclude enrollment. Examples of significant medical problems include, but are not limited to, morbid obesity or severe cardiac disease.
* Kidneys that are to be implanted en bloc or from donors less than 6 years old.
* Kidneys from donors that are known or suspected to have an active infection with or be seropositive for HBsAg, hepatitis B core antibody (HBcAb), HCV, or HIV.
* Kidneys from donors that have received investigational therapies designed to reduce the impact of ischemia reperfusion, DGF, or other donor-related immune events.
* Donor kidney is preserved by cold storage (with or without machine preservation) for less than 16 hours, with the exception of kidneys from non-heart-beating donors or kidneys from donors greater than 50 years old or donors with a SCr above 2.5mg/dL.
B: Inclusion Criteria:

* Patients who are recipients of primary or secondary renal allograft.
* Patients who are single-organ recipients (kidney only).

Exclusion Criteria:

•Patients who are recipients of HLA-identical renal transplants. Patients whose donor kidney cold ischemia time (CIT) is greater than 36 hours. Patients whose transplant kidney is obtained from a non-heart beating donor Other protocol-defined exclusion criteria may apply.
C: Inclusion Criteria:

* Male or female patients between 18 - 75 years
* Recipients of single-organ renal primary allograft or second renal transplants (provided that the previous graft was not lost from acute rejection within the first year) from living or cadaver donors
* Patients who provide written informed consent.

Exclusion Criteria:

* PRA \> 20% within 6 months prior to enrollment
* Cold ischemia time \> 30 hours
* Previous treatment with daclizumab
* History of malignancy (except localized skin cancer)
* Active peptic ulcer disease.
D: Inclusion Criteria:

* Male or female patients between 18 and 65 years of age
* Male or female patients who are primary cadaveric, living unrelated or non-HLA identical living related donor renal transplant recipients
* The renal cold ischemic time (CIT) must be \< 30 hours
* The age of the donor must be between 10 and 59 years and not meet UNOS expanded donor criteria

Exclusion criteria

* Patients meeting any of the following criteria at baseline will be excluded from study participation.
* Patients who have previously received an organ transplant
* Patients who are recipients of a multiple organ transplants
* Recipients of non heart-beating donor organs

Other protocol define inclusion/exclusion criteria may apply. Patients who are recipients of A-B-O incompatible transplants or T-cell crossmatch positive transplants Patients with current panel reactive T-cell antibodies (PRA) titers of 50% or more (when the test is performed with dithiothreitol treated patient's serum) Patients who are known to have a positive hepatitis C serology, who are human immunodeficiency virus (HIV) or Hepatitis B surface antigen positive. Laboratory results obtained within 6 months prior to first dose of everolimus are acceptable. Recipients of organs from donors who test positive for Hepatitis B surface antigen or Hepatitis C are excluded Presence of cardiac disease ( Old New York Heart Association Classification Grade 3, elevated creatine phosphokinase myocardial binding isoenzyme (CPK-MB)or any cardiac disease considered to be unsafe for the study by the investigator) 10.Presence of severe hypercholesterolemia ( 350 mg/dL, 9.1 mmoL/dL) or hypertriglyceridemia ( 500mg/dL, 5.6 mmoL/L). Patients with controlled hyperlipidemia are acceptable 11.White blood cell (WBC) count 4500/mm3, or platelet count 100,000/mm3 12.Evidence of liver injury as indicated by an abnormal liver profile (AST, ALT, alkaline phosphatase or total bilirubin 3 times ULN) before transplantation 13.Presence of any severe allergy requiring acute (within 4 weeks of baseline) or chronic treatment, or hypersensitivity to drugs similar to everolimus (e.g., macrolides) 14.The use of any investigational drug within 4 weeks of the baseline period 15.Patients who have been treated with non-protocol immunosuppressive drug or treatment within 1 month prior to first dose of everolimus 16.Patients with severe systemic infections 17.Existence of any surgical or medical condition, other than the current transplant, which in the opinion of the investigator, preclude enrollment in this trial 18.Malignancy (current or history within last 5 years) except for successfully treated localized basal or squamous cell carcinoma of the skin 19.Patients with any medical condition requiring long-term anticoagulation, such as heparin, low molecular weight heparin, or warfarin, after transplantation (Low dose aspirin, clopidogrel, or cilostazol treatment is allowed) 20.Abnormal physical or laboratory findings of clinical significance within 2 weeks prior to first dose of everolimus which at investigators discretion would interfere with the objectives of the study 21.Breast feeding women 22.Patients with symptoms of significant somatic or mental illness. Unresolved history of drug or alcohol abuse 23.Inability to cooperate or communicate with the investigator 24.Donors that meet the UNOS expanded donor criteria

Answer: A