drugset / Trial / 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

NCT04542733

Active not recruiting 50 enrolled King Chulalongkorn Memorial Hospital
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2023-06-15
Primary completion
2027-12-31
Completion
2028-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Everolimus Small molecule
Comparator Leflunomide Small molecule 40 mg
Comparator Tacrolimus Small molecule