Please select the eligibility criteria that correspond to the clinical trial below.
Title: Immunosuppression in Renal Transplantation in The Elderly: Time to Rethink. - nEverOld Study
Brief Summary: An exploratory study of the efficacy and safety of a regimen consisted of Everolimus plus low tacrolimus for the immunosuppression in renal transplantation in the elderly.

To evaluate the pharmacokinetics of immunosuppressants that have been little studied in this population.

To evaluate whether the polymorphism of the genes that determine the expression of metabolizing enzymes and transporters of xenobiotics interfere in the elderly, also in the younger population, absorption and metabolism of immunosuppressants.

To evaluate the potential minimization of immunosuppression in this population refers to how does the re-population of peripheral lymphocytes, in this age group, after the use of lymphocyte-depleting agents such as thymoglobulin and subsequently maintained with two regimes.

Clarify which markers of renal filtration exist today, cystatin C and serum creatinine, is the right to monitor renal function in elderly transplanted.


Options:
A: 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.
B: Inclusion Criteria:

* All renal (only) male and female recipients aged ≥ 60, years undergoing kidney transplantation from a living or deceased donor, including Expanded Criteria Donors (ECD).
* Panel Reactive Antibody (PRA) \< 30%.
* Patients who consented to participate in the study by signing the informed consent form before the transplant surgery to the 1st post-operative day).

Exclusion Criteria:

* Allergy to any of proposed medications
* Patients with any active infection including HBV, HCV and HIV.
C: Inclusion Criteria:

* Age \>14 years
* Weight \> 40 kg
* Primary renal allograft: cadaveric or mismatched living donor
* Negative standard cross match for T-cells
* Women of childbearing potential will be required to have a negative qualitative serum pregnancy test and agree to use an adequate method of contraception throughout the study period and for 3 months after discontinuation of study medication (3yrs, 3 mos.)
* Signed and dated informed consent (Parent or legal guardian must provide written consent for patients \<18 years of age)

Exclusion Criteria:

* Evidence of systemic infection
* History of malignancy within 10 years (with the exception of localized skin cancer)
* Use of any investigational drug or treatment up to 4 weeks prior to enrolling in the study and during the 12-month treatment phase
* Concurrent use of astemizole, pimozide, cisapride, terfenadine, or ketoconazole
* Known hypersensitivity to sirolimus and its derivatives
* 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
D: 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 (12 months). Parent or legal guardian must provide written consent for patients \<18 years of age.
2. Age 18-75 years.
3. Weight \> 40 kg.
4. Primary or secondary renal allograft: living or deceased donor.
5. Negative standard crossmatch for T cells.
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 the study duration.
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), 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 of an investigational drug in the 30 days prior to transplant.
8. Patient will be receiving any immunosuppressive agent other than 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) (Group I only).
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, thymoglobulin, IL-2 receptor inhibitor monoclonal antibodies, sirolimus, MMF, Myfortic®, 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 \>200 mg/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 the opinion of the investigator, may invalidate communication with the investigator.

If tacrolimus cannot be instituted for longer than 5 days postoperatively.

Answer: B