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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mTORi with reduced-dose tacrolimus | Active Comparator | Patient will received everolimus with target trough concentration of 3-6 ng/mL and tacrolimus with target trough concentration of 2-4 ng/mL. Duration for this regimen would be at least 3 months. |
|
| reduced-dose tacrolimus and Leflunomide | Active Comparator | Patient will receive tacrolimus with target concentration of 3-6 ng/mL with leflunomide 100 mg/day loading dose for 5 days, followed by 40 mg/day thereafter. Duration for this regimen would be at least 3 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Everolimus | Drug | Everolimus will be given with tacrolimus. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma BK viral load change | 6-month plasma BK viral load change from randomization | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma BK viral load clearance rate | Percentage of patients who have negative plasma BK virus at specific time point after randomization | 1, 3, 6 months |
| Acute rejection rate | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suwasin Udomkarnjananun, MD, MSc | Chulalongkorn University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Chulalongkorn Memorial Hospital | Bangkok | Bangkok | 10330 | Thailand |
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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.
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| reduced dose tacrolimus and Leflunomide |
| Drug |
Reduced dose tacrolimus will be given with leflunomide |
|
| Glomerular filtration rate (GFR) change | GFR change at specific timepoint after randomization | 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) | 6 months |
| ID | Term |
|---|---|
| D000068338 | Everolimus |
| D000077339 | Leflunomide |
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D007555 | Isoxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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