Kidney transplantation
Conditions
Interventions
A:low-dose tacrolimus+MPA+prednison
B:low-dose tacrolimus+sirolimus+prednison
Sponsors
The First Affiliated Hospital, College of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Aged >= 18 years old; 2) Male or female renal transplant recipients (initial or retransplantation); 3) receiving cadaveric donor kidney, non-living related donor kidney or living related donor kidney; 4) Baseline immunosuppressive regimen consists of tacrolimus, mycophenolic acid (MPA) and prednisone; 5) Routine BK virus screening found BK virus urinuria >= 105 copies/mL, and/or viremia (> 500 copies/mL); 6) Subjects must be able and willing to provide written informed consent and comply with the requirements of this study protocol.
Exclusion criteria
Exclusion criteria: 1) Transplant patients with ABO blood group incompatibility; 2) Patients with abnormal liver function, such as alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin > 3 × ULN; 3) Patients with severe hypercholesterolemia (> 350 mg/dL (9.1 mmol/L) or hypertriglyceridemia (> 500 mg/dL (5.65 mmol/L)) (patients receiving lipid-lowering drugs to control hyperlipidemia can be included); 4) Patients with known allergy to study drugs or similar chemical drugs; 5) Patients with any surgical or medical diseases, such as severe diarrhea, active peptic ulcer or uncontrolled diabetes. The researchers believe that these may significantly change the absorption, distribution, metabolism and/or excretion of the study drug; 6) pregnant women, lactating women; 7) Patients with baseline urine protein/creatinine ratio > 500 mg/day; 8) Patients with estimated glomerular filtration rate (eGFR) < 30ml/min; 9) Patients receiving desensitization therapy; 10) There are other conditions that are not suitable for the use of the test drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| copy of BK virus in urine; | — |
Secondary
| Measure | Time frame |
|---|---|
| urinary protein/creatinine;urinary routine test;count and activity of immunocyte;blood routine test;level of serum immunoglobulin (IgG?IgA?IgM);level of serum creatinine;level of serum BUN; | — |
Countries
China
Contacts
Public ContactHongfeng Huang
The First Affiliated Hospital, College of Medicine, Zhejiang University
Outcome results
None listed