The Efficacy of Everolimus With Reduced-dose Tacrolimus Versus Reduced-dose Tacrolimus and Leflunomide in Treatment of BK Virus Infection in Kidney Transplantation Recipient
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Plasma BK viral load change
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
reduced-dose tacrolimus and Leflunomide
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.
Intervention: reduced dose tacrolimus and Leflunomide (Drug)
mTORi with reduced-dose tacrolimus
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.
Intervention: Everolimus (Drug)
Outcomes
Primary Outcomes
Plasma BK viral load change
Time Frame: 3 months
3-month plasma BK viral load change from randomization
Secondary Outcomes
- Acute rejection rate(6 months)
- Plasma BK viral load clearance rate(1, 3, 6 months)
- Acute rejection rate(6 months)
- Glomerular filtration rate (GFR) change(3, 6 months)
- Chronicity score in kidney allograft(6 months)
- Plasma BK viral load clearance rate(1, 3, 6 months)
- 6-month plasma BK VL(6 months)
- Glomerular filtration rate (GFR) change(3, 6 months)
- Chronicity score in kidney allograft(6 months)
Investigators
Suwasin Udomkarnjananun
Principle investigator
King Chulalongkorn Memorial Hospital