Clinical Trial

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

Study acronym: ELF
Active, Not Recruiting
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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.
Protocol Amendment History 3 changes
critical Trial status changed: Recruiting → Active, Not Recruiting 2026-05-29
notable Primary completion pushed: 2025-12-24 -> 2027-12-31 2026-05-29
minor Completion pushed: 2026-07 -> 2028-07 2026-05-29
Trial Details
NCT Number NCT04542733
Lead Sponsor King Chulalongkorn Memorial Hospital
Conditions Kidney Transplant Infection, BK Virus Infection
Enrollment 50 participants
Start Date 2023-06-15
Primary Completion 2027-12-31 (estimated)
Study Completion 2028-07 (estimated)
Updated on ClinicalTrials.gov 2026-05-28