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

King Chulalongkorn Memorial Hospital

Status: Enrolling

Conditions: Kidney Transplant Infection; BK Virus Infection

Treatments: Drug: Everolimus; Drug: reduced dose tacrolimus and Leflunomide

Study type: Interventional

Funder types: Other

Identifiers

NCT04542733

CUKT02/63

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

mTORi with reduced-dose tacrolimus

Active Comparator group

Description:

Patient will received everolimus with target trough concentration of 3-6 ng/mL and tacrolimus with target trough concentration of 2-4 ng/mL. Duration for this regimen would be at least 3 months.

Treatment:

Drug: Everolimus

reduced-dose tacrolimus and Leflunomide

Active Comparator group

Description:

Patient will receive tacrolimus with target concentration of 3-6 ng/mL with leflunomide 100 mg/day loading dose for 5 days, followed by 40 mg/day thereafter. Duration for this regimen would be at least 3 months.

Treatment:

Drug: reduced dose tacrolimus and Leflunomide