BK Virus Infection, Kidney Transplant Infection
Conditions
Keywords
Kidney Transplantation, mTOR inhibitor, Leflunomide, BK virus
Brief summary
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.
Interventions
DRUGEverolimus
Everolimus will be given with tacrolimus.
DRUGreduced dose tacrolimus and Leflunomide
Reduced dose tacrolimus will be given with leflunomide
Sponsors
King Chulalongkorn Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All patients met inclusion criteria will be randomized after BK VL not respond to mycophenolic acid and tacrolimus reduction as a run-in phase for 1 month. The intervention arms include everolimus + reduced dose tacrolimus and leflunomide + reduced dose tacrolimus.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Kidney transplant recipients at King Chulalongkorn Memorial Hospital * age \>= 18 years * persistent BK viremia \>1000 copies/mL at least 2 times in 3 weeks or single time \> 10000 copies/mL
Exclusion criteria
* BK VL \>10\^5 log * Previous BKVAN treatment * Drug hypersensitivity to mTORi or leflunomide
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma BK viral load change | 6 months | 6-month plasma BK viral load change from randomization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma BK viral load clearance rate | 1, 3, 6 months | Percentage of patients who have negative plasma BK virus at specific time point after randomization |
| Acute rejection rate | 6 months | — |
| Glomerular filtration rate (GFR) change | 3, 6 months | GFR change at specific timepoint after randomization |
| Chronicity score in kidney allograft | 6 months | Banff's criteria for allograft biopsy tissue, focus on ci and ct scores ranging from 0 (no chronicity lesion) to 3 (severe chronicity lesion) |
Countries
Thailand
Contacts
PRINCIPAL_INVESTIGATORSuwasin Udomkarnjananun, MD, MSc
Chulalongkorn University
Outcome results
None listed