Please select the eligibility criteria that correspond to the clinical trial below.
Title: Multi-center, Open-label, Prospective, Randomized, Parallel Group, Long-term Study Investigating a Standard Regimen in de Novo Kidney Transplant Patients Versus a CNI-free Regimen and a CNI-low Dose Regimen
Brief Summary: The purpose of this study is to compare renal function of immunosuppressive regimens with different relevance of the calcineurin inhibitor (CNI) cyclosporine: standard dose CNI, low dose CNI, CNI free in de novo kidney transplant patients after 12 months of therapy.


Options:
A: Inclusion criteria

* Males or females, aged 18 - 70 years
* Recipients of de novo cadaveric, living unrelated or living related kidney transplants
* Females capable of becoming pregnant must have a negative serum pregnancy test within 7 days prior to or at screening, and are required to practice an approved method of birth control for the duration of the study and for a period of 6 weeks following discontinuation of study medication, even where there has been a history of infertility.
* Patients who are willing and able to participate in the study and from whom written informed consent has been obtained.

Exclusion criteria

* More than one previous renal transplantation
* Multi-organ recipients (e.g., kidney and pancreas) or previous transplant with any other organ, different from kidney
* Patients receiving a kidney from a non-heart beating donor
* Donor age: \< 5 years or \> 70 years
* Graft loss due to immunological reasons in the first year after transplantation (in case of secondary transplantation)
* Other protocol-defined inclusion/exclusion criteria may apply
B: 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
C: Inclusion Criteria:

* Male and female patients of any race between 18 to 70 years old (inclusive)
* Patients who gave written informed consent to participate in the study

Exclusion Criteria:

* Recipients of multi-organ transplantation
* Recipients of a primary cadaveric or primary non-human leucocyte antigen (HLA) identical living donor kidney transplantation.
* Graft cold ischemia time greater than 40 hours.

Other protocol-defined inclusion/exclusion criteria may apply.
D: Inclusion Criteria:

* Male or female patients between 15 and 75 years of age, regardless of race.
* Female patients of child bearing age agree to maintain effective birth control practice during the study.
* Patient has end stage kidney disease and is a suitable candidate for primary renal transplantation or retransplantation as assessed by the transplantation center.
* Patient has been fully informed and has given written or independent person witnessed oral informed consent.

Exclusion Criteria:

* Patient is pregnant or breastfeeding.
* Patient has a low immunological risk constellation, defined by receiving a kidney from a HLA-identical related living donor.
* Patient has a high immunological risk constellation, defined as having within the previous three years a measured PRA grade of ≥25% and/or having a previous graft survival shorter than 3 years due to rejection.
* Patient and donor have a positive T or B-cell crossmatch.
* Patient and donor are ABO incompatible.
* Age of donor \> 68 years.
* Cold ischemia time \> 36 hours.
* Patient has leucopenia, defined as having at transplantation less than 3000/mm3 leukocytes.
* Patient has thrombocytopenia, defined as having at transplantation less than 75000/mm3 thrombocytes.
* Patient is allergic or intolerant to cremophor RH 60 or structurally related compounds, steroids, Cyclosporine A Neoral, Rapamycin or MMF.
* Patient requires initial sequential or parallel therapy with immunosuppressive antibody preparation(s).
* Patient or donor is known to be HIV positive.
* Patient has significant liver disease, defined as having during the past 28 days continuously ASAT (SGOT) and/or ALAT (SGPT) levels greater than 3 fold of the upper value of the normal range of the investigational site.
* Patient with malignancy or history of malignancy ≥ 2 years, except non metastatic basal or squamous cell carcinoma of the skin that has been treated successfully.
* Patient has significant, uncontrolled concomitant infections and/or severe diarrhea, vomiting, or active peptic ulcer.
* Patient is taking or has been taking an investigational drug in the past 28 days.
* Patient has previously received or is receiving another organ transplant other than kidney.
* Patient is unlikely to comply with the visits schedule in the protocol.

Answer: A