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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

NCT04542733 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-12-31

No results posted yet for this study

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.

Conditions

  • Kidney Transplant Infection
  • BK Virus Infection

Interventions

DRUG

Everolimus

Everolimus will be given with tacrolimus.

DRUG

reduced dose tacrolimus and Leflunomide

Reduced dose tacrolimus will be given with leflunomide

Sponsors & Collaborators

  • King Chulalongkorn Memorial Hospital

    lead OTHER

Principal Investigators

  • Suwasin Udomkarnjananun, MD, MSc · Chulalongkorn University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-10
Primary Completion
2025-12-24
Completion
2026-07-31

Countries

  • Thailand

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04542733 on ClinicalTrials.gov