Kidney transplant status
Conditions
Interventions
Experimental group:Extended-release tacrolimus
Control group:Immediate-release tacrolimus
Sponsors
The Affiliated Hospital of Xuzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Male and female, aged 18-65; 2. Patients with end-stage renal disease who received live/cadaveric kidney transplantation for the first time; 3. After kidney transplantation, patients must be receiving a standard triple immunosuppressive regimen consisting of a mycophenolic acid (MPA) agent + tacrolimus (TAC) + glucocorticoids. 4. Patients have provided informed consent and are able to attend regular follow-up visits and provide all information required for this study.
Exclusion criteria
Exclusion criteria: 1. Multi-organ recipients, such as those who have undergone transplants of other organs including the heart, lungs, liver, etc.; 2. Those with severe heart, lung and liver cirrhosis or malignant tumors; 3. Those with severely abnormal liver function (e.g., an increase in any of ALT, AST, total bilirubin, etc. by more than 2.5 times the normal value); 4. Those who are allergic to tacrolimus and other macrolide drugs or their components (hypersensitivity reaction); 5. Those who need to be used in combination with drugs that affect the metabolism of CYP3A4 enzymes, such as: strong inhibitors such as tipranavir, bosentan, ritonavir, ketoconazole, itraconazole, teriflunomide, clarithromycin or nelfinavir, inducers such as rifampicin, rifabutin, and Chinese herbal preparations containing St. John's wort, etc.; 6. Pregnant women, lactating women or those planning to become pregnant; 7. Those with severe/uncontrolled concurrent infections or other serious medical problems; 8. Patients determined by the investigator to be not suitable for inclusion in this study for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tacrolimus blood concentration; | — |
Secondary
| Measure | Time frame |
|---|---|
| Intra-patient variability of tacrolimus trough concentration;Incidence of acute rejection;Graft loss rate;Patient survival rate;Change in renal function;Incidence of treatment-emergent adverse events (TEAEs); | — |
Countries
China
Contacts
Public ContactZhu Haitao
The Affiliated Hospital of Xuzhou Medical University
Outcome results
None listed