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

Not Applicable

Recruiting

• Conditions: Kidney Transplant Infection; BK Virus Infection
• Interventions: Drug: reduced dose tacrolimus; Drug: Everolimus

• Registration Number: NCT04542733
• Lead Sponsor: King Chulalongkorn Memorial Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-27
• Study First Submitted QC: 2020-09-02
• Study First Posted: 2020-09-09
• Study Start: 2021-02-10
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-05
• Primary Completion: 2025-09
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
reduced-dose tacrolimus	reduced dose tacrolimus	Patient will receive tacrolimus with target concentration of 3-6 ng/mL with or without 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.
mTORi with reduced-dose tacrolimus	Everolimus	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.

Primary Outcome Measures

Name	Time	Method
Plasma BK viral load change	3 months	3-month plasma BK viral load change from randomization

Secondary Outcome Measures

Name	Time	Method
Plasma BK viral load clearance rate	1, 3, 6 months	Percentage of patients who have negative plasma BK virus at specific time point after randomization
Glomerular filtration rate (GFR) change	3, 6 months	GFR change at specific timepoint after randomization
Chronicity score in kidney allograft	6 months	Banff's criteria for allograft biopsy tissue, focus on ci and ct scores ranging from 0 (no chronicity lesion) to 3 (severe chronicity lesion)
Acute rejection rate	6 months

Trial Locations

Locations (1)

King Chulalongkorn Memorial Hospital; 🇹🇭 Bangkok, Thailand