NCT04542733

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: King Chulalongkorn Memorial Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Kidney Transplant Infection
• BK Virus Infection

Interventions

Type	Name	Description
DRUG	Everolimus	Everolimus will be given with tacrolimus.
DRUG	reduced dose tacrolimus and Leflunomide	Reduced dose tacrolimus will be given with leflunomide

Timeline

• Start date: 2021-02-10
• Primary completion: 2025-12-24
• Completion: 2026-07-01
• First posted: 2020-09-09
• Last updated: 2025-12-31

Locations

1 site across 1 country: Thailand