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Clinical Trials/NCT04542733
NCT04542733Active, not recruitingNot Applicable

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

King Chulalongkorn Memorial Hospital2 sites in 1 country50 target enrollmentStarted: June 15, 2023Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
50
Locations
2
Primary Endpoint
Plasma BK viral load change

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

reduced-dose tacrolimus and Leflunomide

Active Comparator

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.

Intervention: reduced dose tacrolimus and Leflunomide (Drug)

mTORi with reduced-dose tacrolimus

Active Comparator

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.

Intervention: Everolimus (Drug)

Outcomes

Primary Outcomes

Plasma BK viral load change

Time Frame: 3 months

3-month plasma BK viral load change from randomization

Secondary Outcomes

  • Acute rejection rate(6 months)
  • Plasma BK viral load clearance rate(1, 3, 6 months)
  • Acute rejection rate(6 months)
  • Glomerular filtration rate (GFR) change(3, 6 months)
  • Chronicity score in kidney allograft(6 months)
  • Plasma BK viral load clearance rate(1, 3, 6 months)
  • 6-month plasma BK VL(6 months)
  • Glomerular filtration rate (GFR) change(3, 6 months)
  • Chronicity score in kidney allograft(6 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Suwasin Udomkarnjananun

Principle investigator

King Chulalongkorn Memorial Hospital

Study Sites (2)

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