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

• Status: Recruiting
• Trial end date: 2025-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: King Chulalongkorn Memorial Hospital
• Treatments: Everolimus; Leflunomide; Tacrolimus

Criteria

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