Actively Recruiting
The Efficacy of Everolimus With Reduced-dose Tacrolimus Versus Reduced-dose Tacrolimus and Leflunomide in Treatment of BK Virus Infection in Kidney Transplantation Recipient
Led by King Chulalongkorn Memorial Hospital · Updated on 2025-12-31
50
Participants Needed
1
Research Sites
281 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
The Efficacy of Everolimus With Reduced-dose Tacrolimus Versus Reduced-dose Tacrolimus and Leflunomide in Treatment of BK Virus Infection in Kidney Transplantation Recipient
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Kidney transplant recipients at King Chulalongkorn Memorial Hospital
- Age 18 years or older
- Persistent BK viremia over 1000 copies/mL at least twice within 3 weeks or a single measurement over 10,000 copies/mL
You will not qualify if you...
- BK viral load greater than 10^5 log
- Previous treatment for BK virus-associated nephropathy (BKVAN)
- Allergy or hypersensitivity to mTOR inhibitors or leflunomide
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
King Chulalongkorn Memorial Hospital
Bangkok, Bangkok, Thailand, 10330
Actively Recruiting
Research Team
S
Suwasin Udomkarnjananun, MD, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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