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

Sponsor

King Chulalongkorn Memorial Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04542733

Collaborator

(none)

Enrollment

Location

Arms

54.7

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Transplant Infection BK Virus Infection	Drug: Everolimus Drug: reduced dose tacrolimus	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 10, 2021

Anticipated Primary Completion Date :

Sep 1, 2025

Anticipated Study Completion Date :

Sep 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: mTORi with reduced-dose tacrolimus 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.	Drug: Everolimus Everolimus will be given with tacrolimus.
Active Comparator: 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.	Drug: reduced dose tacrolimus Reduced dose tacrolimus will be given with or without leflunomide

Arm

Intervention/Treatment

Active Comparator: mTORi with reduced-dose tacrolimus

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.

Drug: Everolimus

Everolimus will be given with tacrolimus.

Active Comparator: 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.

Drug: reduced dose tacrolimus

Reduced dose tacrolimus will be given with or without leflunomide

Outcome Measures

Primary Outcome Measures

Plasma BK viral load change [3 months]
3-month plasma BK viral load change from randomization

Secondary Outcome Measures

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
Acute rejection rate [6 months]
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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