Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04542733

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

King Chulalongkorn Memorial Hospital

Bangkok, Bangkok, Thailand, 10330

Actively Recruiting

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