RecruitingNot ApplicableNCT04542733

The Efficacy of Everolimus With Reduced-dose Tacrolimus Versus Reduced-dose Tacrolimus and Leflunomide in Treatment of BK Virus Infection in Kidney Transplantation Recipient


Sponsor

King Chulalongkorn Memorial Hospital

Enrollment

50 participants

Start Date

Feb 10, 2021

Study Type

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

Min Age: 18 Years

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

DRUGEverolimus

Everolimus will be given with tacrolimus.

DRUGreduced dose tacrolimus and Leflunomide

Reduced dose tacrolimus will be given with leflunomide


Locations(1)

King Chulalongkorn Memorial Hospital

Bangkok, Bangkok, Thailand

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NCT04542733


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