Please select the eligibility criteria that correspond to the clinical trial below.
Title: Evaluating Safety and Efficacy of MMF, Daclizumab and Corticosteroids as Mainstay Immunosuppression in Combination With Low-Dose CsA, Tac or Sir in Comparison to Current Standard Immunosuppression (MMF, CsA and Corticosteroids) in Renal Tx
Brief Summary: To determine the renal function, as expressed by the glomerular filtration rate at 12 months, in renal transplant recipients receiving mycophenolate mofetil, daclizumab, and corticosteroids as mainstay immunosuppression in combination with low-dose cyclosporine, tacrolimus, or sirolimus, and compare it to that of renal transplant recipients receiving standard immunosuppression with mycophenolate mofetil, normal dose cyclosporine and corticosteroids.


Options:
A: 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.
B: 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.
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: Core Study Inclusion Criteria:

* Male or female de novo renal transplant recipients between 18 and 65 years of age
* Patients who are receiving a primary cadaveric donor or non-human leukocyte antigen (non-HLA) identical living donor kidney transplant
* Patients who have given written informed consent to participate in the study
* Females capable of becoming pregnant must have a negative pregnancy test prior to randomization.

Core Study Exclusion Criteria:

* Patients with no evidence of graft function within 24 hours of transplantation are excluded
* Recipients of dual kidney transplants
* Patients who are recipients of multiple solid organ or tissue transplants, or have previously received an organ or tissue transplant.
* Recipients of kidneys from HLA-identical living related donors
* Patients who are recipients of ABO incompatible transplants or T cell cross match positive transplant. Although Panel Reactive Antibodies (PRA) test is not mandatory, patients whose most recent anti-HLA Class I PRA \>20% By a CDC-(Complement dependent cytotoxicity) based assay or \>50% by a Flow Cytometry or ELISA (Enzyme linked immunosorbent assay) -based assay
* Patients who have tested positive for human immunodeficiency virus (HIV), hepatitis C virus (HCV), or Hepatitis B surface antigen. Laboratory results obtained within 6 months prior to randomization are acceptable, otherwise these tests should be performed within two weeks prior to randomization.
* Recipients of organs from donors who test positive for Hepatitis B surface antigen, HCV or HIV are excluded
* Donor organ with a cold ischemia time \>24 hours
* Donor age greater than 65 years
* Patients with platelet count \<100,000/mm at baseline before transplantation
* Patients with an absolute neutrophil count of \< 1,500/mm³ or white blood cell count of \< 4,500/mm³ at baseline before transplantation
* Patients who have severe hypercholesterolemia (\>350 mg/dL; \>9 mmol/L) or hypertriglyceridemia (\>500 mg/dL; \>8.5 mmol/L). Patients with controlled hyperlipidemia are acceptable
* Patients who have an abnormal liver profile such as alanine aminotransferase (ALT), Aspartate aminotransferase (AST), alkaline phosphatase (ALP) or total bilirubin \>3 times the upper limit of normal (ULN)
* Patients with a known hypersensitivity to either of the study drugs or their class, or to any of the excipients
* Patients who are treated with drugs that are strong inducers or inhibitors of cytochrome P450
* Patients who are unable to take oral medication at time of randomization
* Patients who received an investigational drug or who have been treated with a non-protocol immunosuppressive drug or treatment within 30 days or 5 half-lives prior to randomization
* Patients with a history of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized excised non-melanomatous skin lesions
* Patients with clinically significant systemic infection at time of transplant or within two weeks prior to transplant
* Patients with a history of severe diarrhea, active peptic ulcer disease, or uncontrolled diabetes mellitus
* Patients who have cardiac failure at time of screening (resting dyspnea, with Grade ≥ 3 according to Old New York Heart Association Classification (Appendix 7) or any severe cardiac disease as determined by the investigator
* Patients who have any surgical or medical condition, which in the opinion of the investigator, might significantly alter the absorption, distribution, metabolism and excretion of study medication
* Patients with abnormal physical or laboratory findings of clinical significance within 2 weeks prior to randomization which would interfere with the objectives of the study
* Patients with any history of coagulopathy or medical condition requiring long-term anticoagulation which would preclude renal biopsy after transplantation. (Low dose aspirin treatment or interruption of chronic anticoagulant is allowed)
* Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception.

Extension Study Inclusion Criteria:

* Patients who completed Month 12 visit in core study (including patients who had discontinued study medication)
* Patients who had given written informed consent to participate in this extension study

Extension Study Exclusion Criteria:

* Women of childbearing potential who were planning to become pregnant, who were unwilling to use two or more effective means of contraception, including abstinence judged by the investigator, surgical sterilization (e.g. bilateral tubal ligation, hysterectomy), hormonal contraception (implantable, patch, oral), and barrier methods (male or female condom with spermicidal gel, diaphragm, sponge, cervical cap). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal were not acceptable methods of contraception.

Other protocol-defined inclusion/exclusion criteria may apply

Answer: B