Kidney Transplantation
Conditions
Interventions
experimental group:Sufficient mycophenolic acid combined with low-dose tacrolimus
control group:Mycophenolic acid in combination with full-dose tacrolimus
Sponsors
The First Affiliated Hospital of Sun Yat-Sen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Donor kidney comes from organ donation or living relatives; 2. The donor kidney is a marginal donor kidney. Based on the previous research and our experience, the following criteria are established, which meet one of the criteria: (1) In case of living donor kidney, any of the following criteria shall be met: Male donor >= 60 years old, female donor >= 55 years old; The donor has a history of hypertension for more than 5 years and the hypertension drugs are controllable; (2) For organ donation, one of the following criteria should be met: The internationally recognized standard of expanded kidney supply (>= 60 years old or 50-59 years old but 2 of 3 standards, i.e. hypertension history, terminal creatinine greater than 133 mmol / L, death due to cerebrovascular disease); The donor had a history of hypertension for more than 5 years; The donor had a history of diabetes for more than 5 years; Zero point pathology showed that the remuzzi score was 2-4; There was no acute renal injury and EGFR < 60 ml / min / 1.73 m2. 3. The age of receptor was 18-75 years old; 4. The recipient received renal transplantation for the first time; 5. Donor specific anti HLA antibody was not detected before the recipient operation; 6. Patients who agree to participate in the study and signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with double kidney transplantation; 2. Patients combined with other organ transplantation; 3. Patients with ABO incompatible kidney transplantation; 4. It is not suitable to use the combination of tacrolimus, mycophenolic acid and glucocorticoid, or to use rATG as induction; 5. Patients with cold ischemia of donor kidney for more than 24 hours; 6. Patients with history of malignant tumor in the past 5 years; 7. Patients with previous drug abuse history; 8. Patients with mental disorders; 9. Patients who cannot be followed up in our hospital for a long time; 10. Patients participating in other clinical trials at the same time.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum creatinine;Estimated glomerular filtration rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence and recovery time of delayed renal function;Incidence of primary graft renal failure;Urinary albumin/creatinine ratio;Survival rate of transplanted kidneys;Survival rate of patients;incidence of exclusion reaction;Postoperative neonatal donor-specific anti-HLA antibody positivity rate;Incidence of infection;Incidence of other adverse events; | — |
Countries
China
Contacts
Public ContactChangxi Wang
The First Affiliated Hospital of Sun Yat-Sen University
Outcome results
None listed