The Efficacy of Everolimus With Reduced-dose Tacrolimus Versus Reduced-dose Tacrolimus and Leflunomide in Treatment of BK Virus Infection in Kidney Transplantation Recipient
King Chulalongkorn Memorial Hospital
50 participants
Feb 10, 2021
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- 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 Criteria3
- BK VL \>10\^5 log
- Previous BKVAN treatment
- Drug hypersensitivity to mTORi or leflunomide
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Interventions
Everolimus will be given with tacrolimus.
Reduced dose tacrolimus will be given with leflunomide
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04542733