BK virus infection is one of the causes of renal allograft loss in the current era. Reduction of immunsuppression is the only intervention that prooved to be effective in treating of BK virus in kidney transplant recipient. However, there are evidences from retrospective and prospective studies showed that leflunomide and mTOR inhibitor such as everolimus or sirolimus have positive outcomes in treatment of BK virus in kidney tranplant recipient. The investigators conduct the RCT to compare the efficacy of leflunomide and mTOR inhibitor everolimus, in treatment of BK virus infected patients who do not respond to immunosuppression reduction.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Everolimus will be given with tacrolimus.
Reduced dose tacrolimus will be given with leflunomide
King Chulalongkorn Memorial Hospital
Bangkok, Bangkok, Thailand
RECRUITINGPlasma BK viral load change
3-month plasma BK viral load change from randomization
Time frame: 3 months
Plasma BK viral load clearance rate
Percentage of patients who have negative plasma BK virus at specific time point after randomization
Time frame: 1, 3, 6 months
Acute rejection rate
Time frame: 6 months
Glomerular filtration rate (GFR) change
GFR change at specific timepoint after randomization
Time frame: 3, 6 months
Chronicity score in kidney allograft
Banff's criteria for allograft biopsy tissue, focus on ci and ct scores ranging from 0 (no chronicity lesion) to 3 (severe chronicity lesion)
Time frame: 6 months
6-month plasma BK VL
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.