Please select the eligibility criteria that correspond to the clinical trial below.
Title: Efficacy and Safety of Induction Strategies Combined With Low Tacrolimus Exposure in Kidney Transplant Recipients Receiving Everolimus or Sodium Mycophenolate
Brief Summary: Despite the improvement of efficacy results with current immunosuppressive regimens (about 15% of incidence of acute rejection), the security schemes used do not show the same results.The most worldwide used regime is tacrolimus, mycophenolate and prednisone. Despite the favorable efficacy results in our population, the use of this combination is associated with higher incidence of viral infections such as cytomegalovirus, and gastrointestinal events, two common causes of hospital readmissions after renal transplantation at our institution.Given this, the investigators propose a study of our own initiative that attends our local needs: identify the best strategy among the therapeutic options available to maintain the result of current effectiveness and improve the safety profile for kidney transplant recipients.This protocol is a prospective, randomized, single center, designed to compare the safety and efficacy of three immunosuppressive regimens: (1) single dose of antithymocyte globulin, reduced exposure to tacrolimus, everolimus starting on day 2 after transplantation and prednisone; ( 2) basiliximab, reduced exposure to tacrolimus, everolimus starting on day 2 after transplantation and prednisone; (3-control group) basiliximab, reduced exposure to tacrolimus, mycophenolate and prednisone.Our hypothesis is that a single dose of antithymocyte globulin or basiliximab induction therapy in combination with low doses of tacrolimus, everolimus and prednisone results in comparable efficacy observed in patients receiving tacrolimus / mycophenolate / prednisone, but with a better safety profile.

To ensure efficacy, the investigators added to the regimes the induction with monoclonal or polyclonal antibody. To improve the toxicities associated with the current scheme, the investigators replace the use of mycophenolate by everolimus and the investigators reduced the dose of tacrolimus.

Patients will be monitored for blood levels of tacrolimus and everolimus to ensure adequate exposure to immunosuppressive agents.


Options:
A: Inclusion Criteria:

* Male or female patients aged over 20 years
* Patient who is judged would have the benefits of the Extended Release Tacrolimus (Advagraf®)treatment by the investigator
* Patients has given written informed consent
* Patient is a recipient of primary or recipient of primary (a living kidney transplant, a cadaveric donor.)
* Patients has received an ABO compatible donor kidney.
* Complement-dependent Cytotoxic Crossmatch: CDC) result: negative
* Female patients of child bearing potential must have a negative urine or serum pregnancy test within 7 days prior to enrollment or upon hospitalization

Exclusion Criteria:

* Patient has previously received an organ transplant other than a kidney.
* Patient has a known hypersensitivity to tacrolimus, Sirolimus (Rapamune®),Mycophenolate mofetil.
* Desensitization
* HLA-identical
* Heart Disease; Heart failure (symptom, EF \<45%)
* Lung Disease; Significant chronic obstructive pulmonary disease, restrictive lung disease
* Patient has an uncontrolled concomitant infection (including Hepatitis B, Hepatitis C) or any other unstable
* malignant tumor history in the 5years prior to enrollment. (except,squamous cell carcinoma)
* Patient has received a kidney transplant from non-heart beating donor
* Cold ischemic time \> 30hrs
* Elevated AST and/or ALT levels greater than 3 times the upper value of the normal range of the investigational site
* (ANC)\<1,500/mm3, (WBC)\<2,500/ mm3, (PLT)\<100,000/ mm3
* ATG: Anti-thymocyte globulin induction
* Medical condition that could interfere with the study objectives.
* Patient is currently taking or has been taking an investigational products in the 30 days prior to enrollment.
* Patient is currently taking or has been taking an prohibited medications in the 28 days prior to enrollment.
* Patient who is judged not to be adequate by the investigator owing to other reasons
* Patient is pregnant or lactating.
* Recipient or donor is known to be seropositive for human immunodeficiency virus.(HIV)
B: Inclusion Criteria:

* low risk adult candidates for first renal transplants from living or deceased donors

Exclusion Criteria:

* receiving immunosuppressive therapy before transplantation;
* have received an investigational medication within the past 30 days;
* have a known contraindication to the administration of antithymocyte globulin;
* tested positive for human immunodeficiency virus (HIV);
* had had cancer (except nonmelanoma skin cancer) within the previous 2 years;
* Pregnant women, nursing mothers, and women of childbearing potential who will be not using condoms or oral contraceptives will be excluded;
* Patients with any panel reactive antibody (PRA) equal to or above 50%, class I or class II.
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:

* Adults (\> 18 years) candidates to renal transplant with expanded criteria deceased donors;
* Low risk of acute rejection, defined as first kidney transplant recipients and Panel Reactive Antibody (PRA) \<50%.
* Signature of the informed consent form (ICF)

Exclusion Criteria:

* Patients receiving immunosuppressive therapy before transplantation;
* Patients who have received an investigational drug within last 30 days;
* Patients with a known contraindication to the administration of an anti-thymocyte globulin;
* Patients with a positive test for human immunodeficiency virus (HIV);
* Patients who had cancer (except non-melanoma skin cancer) within last two years;
* Pregnant women, breastfeeding women, and women of childbearing potential unwilling to use condoms or oral contraceptives will be excluded;
* Patients with any Panel Reactive Antibody (PRA) equal to or higher than 50%, class I or class II, will also be excluded;
* Patients with positive test for parasites (protozoa and helminths).

Answer: B