Please select the eligibility criteria that correspond to the clinical trial below.
Title: An Open-Label Study to Evaluate the Efficacy and Safety of Cyclosporine Reduction in de Novo Renal Allograft Recipients Receiving Sirolimus: a Dose Comparative Study
Brief Summary: To evaluate the safety and efficacy of different doses of cyclosporine given concomitantly with a fixed dose of sirolimus in kidney transplant recipients.


Options:
A: 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
B: Inclusion Criteria:

* 1. Patients of either gender above 18 years of age at time of randomisation. 2. More than twelve months posttransplant. 3. Treated with an immunosuppressive protocol consisting of CsA, MMF and steroid from the time of discharge from the transplant clinic (e.g. 3 months posttransplant).

  4. Kidney (only) transplant recipients with stable renal function (S-creatinine \< 300 umol/L and an average increase in S-creatinine \< 20% the last 6 months prior to inclusion) and without treated clinically and/or biopsy proven acute rejection episodes the last 6 months prior to inclusion.

  5. No previous steroid resistant acute rejections (e.g. treated with ATG/OKT3). 6. Not more than two steroid sensitive acute rejections posttransplant. 7. Signed informed consent.

Exclusion Criteria:

- 1. PRA positivity \> 20%. 2. Concomitant therapy with other investigational drugs or prohibited medication specified in the protocol.

3. Life expectancy less than one year. 4. Acute illness or acute fungal, bacterial or viral infection at screening. 5. Unable and/or unlikely to follow the study protocol.
C: Inclusion Criteria:

* Patients, 18 years or older, on triple maintenance therapy with cyclosporine or tacrolimus , MMF and steroids
* Informed consent

Exclusion Criteria:

* Calculated creatinine clearance \< 30 ml/min
* Multi-organ recipients
* Patients with a (historic) panel reactive antibody (PRA) \>60%
* Third renal transplant or more.
* Patients receiving investigational drugs other than MMF in combination with cyclosporine or tacrolimus
* Solid malignancy, post-transplant lymphoproliferative disease.
D: Inclusion criteria

* At least 18 years of age
* End-stage renal disease in patients receiving a primary or secondary renal allograft from a cadaveric, living-unrelated, or living-related mismatched donor
* Patients with secondary kidney transplant must have maintained primary graft for at least 6 months

Exclusion criteria

* Antibody induction within one week of current transplantation
* Multiorgan transplants
* Patients at high-risk of rejection

Answer: D