Renal transplantation
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. De novo kidney transplantation; 2. Kidneys from adult DCD donors*; 3. Adult recipient; 4. Weight between 50-80 kg; 5. Negative result of pregnancy for women; 6. Provide written informed consent for study participation; 7. Using Simulect as induction therapy; 8. Using EC-MPS at Day 1 after transplantation surgery. * Potential DCD donors are limited to patients who have died, or whose death is imminent, whose medical treatment no longer offers a medical benefit to the patient as determined by the patient, the patient's authorized surrogate, or the patient's advance directive if applicable, in consultation with the healthcare team. Any planned withdrawal of life sustaining medical treatment/support will be carried out in accordance with hospital policy. Prior to the OPO initiating any discussion with the legal next-of-kin about organ donation for a potential DCD donor, the OPO must confirm that the legal next-of-kin has elected to withdraw life sustaining medical treatment. The timing of a potential DCD donor evaluation and donation discussion will be coordinated with the OPO and the patient's healthcare team, in accordance with hospital policy. Death is declared by a healthcare team member in accordance with hospital policy and applicable state and local statues or regulation. A DCD donor may also be called a non-heartbeating, asystolic, or donation after cardiac death donor.
Exclusion criteria
Exclusion criteria: Exclusion criteria Recipient 1. Multi-organ transplantation; 2. ABO blood type incompatibility; 3. PRA>10%; 4. Donor Specific Antibody (DSA) positive; 5. WBC =7.0 mmol/L or 2-hour plasma glucose (2hPG) >=11.1mmol/L Donor; 1. Age beyond 60; 2. Cold ischemia time >18h; 3. Warm ischemia time >30 min; 4. Mean urine volume within 6 hours before donation 10 Days; 6. Last creatinine before donation >200 umol/L.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incidence of acute rejection;graft survival rate;patient survival rate; | — |
Countries
China