Clinical Outcome of Delayed or Standard Prograf Together With Induction Therapy Followed by Conversion to Advagraf in Donation After Cardiac (or Circulatory) Death (DCD) Kidney Transplant Recipients

Inclusion criteria

• Subject has end-stage kidney disease who is a suitable candidate for primary DCD kidney transplantation.
• Subject is a resident of China.
• Subject is scheduled to undergo DCD renal allograft transplantation with compatible ABO blood type.
• Subject has peak panel-reactive antibodies (PRA) < 10% or "Negative" test result.
• Subject must be a recipient of a DCD kidney and receive the organ distributed by China Organ Transplant Response System only.
• Female subject must either:

• Be of non-childbearing potential: Postmenopausal (defined as at least 1 year without any menses for which there is no other obvious pathological or physiological cause) prior to screening, or documented surgically sterile
• Or, if of childbearing potential: Agree not to try to become pregnant throughout the study period and have a negative blood pregnancy test at screening.
• A sexually active male or female subject is utilizing highly effective forms of birth control starting at screening and throughout the study period if the risk of conception exists.
• Subject agrees not to participate in another interventional study while participating in the present study from 1 month before randomization to 1 month after the last dose of investigational drug.

Exclusion criteria

• Subject has previously received or is receiving an organ transplant other than kidney.
• Subject is receiving double-kidney transplant.
• Recipients of Maastricht Class I, II, and V donor organs.
• Recipients of Maastricht Class III and IV donor organs without a full complement of intensive care unit and intraoperative records.
• Subject has cold ischemia time of allograft > 24 hours before kidney transplantation surgery.
• Subject has known contraindication to administration of tacrolimus (Prograf or Advagraf), or other macrolides.
• Subject is unlikely to comply with the visits scheduled in the protocol or has a history of non-compliance.
• Subject has evidence of active liver disease or the presence of a chronic active hepatitis B or C within 1 month prior to kidney transplant surgery.
• Recipient or donor is seropositive for human immunodeficiency virus.
• Subject has active systemic infection requiring the use of antimicrobial agents within 1 week prior to kidney transplant surgery.
• Subject has current malignancy or a history of malignancy (within the past 5 years), except non- metastatic basal or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix that has been treated successfully.
• Subject has medical or psychological conditions which would preclude compliance with the study requirements.
• Subject has any condition, including any uncontrolled disease state other than end-stage kidney disease, that constitutes an inappropriate risk or a contraindication for participation in the study, or that could interfere with the study objectives, conduction, or evaluation.
• Female subject who breastfeed or donate ova starting at screening and throughout the study period.
• Male subject who donate sperm starting at screening and throughout the study period.