Kidney Graft Function Under the Immunosuppression Strategies
Kidney Graft Function Under the Immunosuppression Strategies
To demonstrate that cyclosporine-sparing immunosuppressions with the standard dose of
 Enteric-Coated Mycophenolate Sodium would preserve renal graft function after transplantation
 without an increase of incidences of adverse events, such as biopsy confirmed acute
 rejection, local or systemic infections, and bone marrow suppression.
This clinical investigation will be the open-label, prospective, multi-center, 1:1 randomized
 comparative, longitudinal, and investigator-initiated study. Patients with end-stage renal
 disease will be assessed for the eligibility, and then be randomized using random number
 table into one of two groups prior to kidney transplantation.

 Immunosuppression consisted of Cyclosporine(Neoral®), Methylprednisolone OR prednisone OR
 deflazacort(Brand name is not designated) and Enteric-Coated Mycophenolate Sodium(Myfortic®).
 Basilixumab(Simulect®) will be given just prior to transplant and 4 days after
 transplantation. The Enteric-Coated Mycophenolate Sodium will be given orally at the dose of
 720 mg BID for Group A (investigational) or 360 mg BID for Group B (comparator), starting at
 two days after transplantation, as shown in the figure below. Cyclosporine will be given
 orally at a dose of 10 mg/Kg/day starting at a day before transplantation. Within a month
 after transplantation, the dose of the drug will be individually adjusted with goal trough
 blood level between 100 ng/mL and 200 ng/mL for Group A or between 200 ng/mL and 300 ng/mL
 for Group B, as displayed in the table below. From a month to 2 months post-transplantation,
 the target blood trough levels of cyclosporine will be reduced to between 75 ng/mL and 150
 ng/mL for Group A or between 150 ng/mL and 250 ng/mL for Group B. From 2 months to 4 months
 post-transplantation, it will be further reduced to between 50 ng/mL and 125 ng/mL for Group
 A or between 125 ng/mL and 200 ng/mL for Group B. After 4 months post-transplantation, it
 will be further reduced to between 50 ng/mL and 100 ng/mL for Group A or between 100 ng/mL
 and 200 ng/mL for Group B.
Inclusion Criteria:

 1. Male or female patients with end-stage renal disease aged 20 to 65 years undergoing
 primary kidney transplantation

 2. Kidney recipients who should be transplanted a kidney from a decease or living donor
 aged between 15 and 65 years

 3. Patients who have given written informed consent to participate in the study

 Exclusion Criteria:

 -  1. multi-organ recipients, or dual kidney recipients or previous transplant recipients
 with any organs including the kidney ,bone marrow, or stem cells.

 2. Recipients who should be transplanted the kidney from a non-heart beating donor, an
 ABO incompatible donor ,or a lymphocyte cross-match positive donor 3. Patients with a
 history of malignancy within the last five years, except for successfully excised
 squamous or basal cell carcinoma of the skin.

 4. Patients with hypersensitivity to Mycophenolate sodium, Mycophenolate acid or
 Mycophenolate Mofetil or to any of the excipients.

 5. Patient with HGPRT(Hypoxanthin e-guanine phosphoribosyl-transferas) such as
 Lesch-Nyhan syndrome and kelley-Seegmiller syndrome.

 6. Patients who have tested positive for HIV, HCV and HBV surface antigen. 7.
 Recipients of organs from donors who tested positive for HBsAg, HCV, HIV 8. Patients
 with any known hypersensitivity to cyclosporine or other components of the
 formulations 9. Patients who are applicable to the contradiction of Sandimune Neoral
 10. Patients who have received any investigational drug within 30 days prior to study
 entry.

 11. 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.

 12. Existence of any surgical or medical condition, other than the current transplant,
 which in the opinion of the investigator might significantly alter the absorption,
 distribution, metabolism or excretion of study medication, and/or presence of severe
 diarrhea, active peptic ulcer disease, or uncontrolled diabetes mellitus.

 13. Evidence of drug, alcohol abuse, and/or other psychiatric illness within the last
 6 months prior to study enroll 14. At the time of the screen evaluation for this
 study, patients with platelet count<50,000/mm3, absolute neutrophil count of
 <1,500/mm3, white blood cell count of < 4,500/mm3, or patients who have an abnormal
 liver profile such as ALT, AST Alk Phos or total bilirubin>3 times the upper normal
 limit.