DCD kidney transplantation.
Conditions
Interventions
Group A:induction therapy + standard Prograf + conversion Advagraf
Group B:induction therapy + delayed Prograf + conversion Advagraf
Sponsors
Tongji Hospital ,Tongji Medical College of Huazhong University of Science & Technology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject with end-stage kidney disease who is a suitable candidate for primary DCD kidney transplantation; 2. Male or female subjects between 18 and 65 years of age, inclusive, at screening; 3. Subjects scheduled to undergo DCD renal allograft transplantation with compatible ABO blood type; 4. Peak panel-reactive antibodies (PRA) < 50%; 5. Preexisting anti-human leukocyte antigen donor-specific antibodies is negative; 6. Subjects are capable of understanding the purposes and risks of the study, who are willing and able to participate in the study, and from whom written and dated informed consent to participate in the study is obtained; 7. Subject must be a recipient of a DCD kidney (graded according to Maastricht classification III or IV) and receive the organ distributed by China Organ Transplant Response System only; 8. Female subject must either: (1) Be of nonchildbearing 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 (e.g., hysterectomy, bilateral salpingectomy, bilateral oophorectomy) (2) Or, if of childbearing potential, Agree not to try to become pregnant throughout the study period (from the start of Screening Period to the end of Follow-up Period), and have a negative blood pregnancy test at screening. 9. Highly effective forms of birth control for both male and female subjects starting at screening and throughout the study period if the risk of conception exists; 10. 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
Exclusion criteria: 1. Subject has previously received or is receiving an organ transplant other than kidney; 2. Subject is receiving double-kidney transplant; 3. Recipients of Maastricht Class I, II, and V donor organs; 4. Recipients of Maastricht Class III and IV donor organs without a full complement of intensive care unit and intraoperative records; 5. Cold ischemia time of allograft is > 24 hours before kidney transplantation surgery; 6. Known contraindication to administration of tacrolimus (Prograf or Advagraf), or other macrolides. 7. Subject is unlikely to comply with the visits scheduled in the protocol in the opinion of the investigator or has a history of non-compliance; 8. Subjects with evidence of active liver disease (liver function tests = 2 times upper limit of normal) or the presence of a chronic active hepatitis B or C within 1 month prior to kidney transplant surgery; 9. Recipient or donor is seropositive for human immunodeficiency virus; 10. Active systemic infection requiring the use of antimicrobial agents within 1 week prior to kidney transplant surgery; 11. 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; 12. Subjects with medical or psychological conditions, the investigator believes, would preclude compliance with the study requirements; 13. Any condition, including any uncontrolled disease state other than end-stage kidney disease, that in the investigators opinion or sponsor/designee opinion constitutes an inappropriate risk or a contraindication for participation in the study, or that could interfere with the study objectives, conduction, or evaluation; 14. Female subject who breastfeed or donate ova starting at screening and throughout the study period; 15. Male subject who donate sperm starting at screening and throughout the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incidence of DGF within 1 week post transplantation; | — |
Countries
China
Contacts
Public ContactGUO Ge
Astellas Pharma China, Inc.
Outcome results
None listed