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Active, Not Recruiting

NCT Number: 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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Kidney Transplant Infection BK Virus Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King Chulalongkorn Memorial Hospital

Bangkok, 10330, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Everolimus

Drug

Everolimus will be given with tacrolimus.

reduced dose tacrolimus and Leflunomide

Drug

Reduced dose tacrolimus will be given with leflunomide

Primary outcomes

  1. Plasma BK viral load change

    Time frame: 6 months

    6-month plasma BK viral load change from randomization

Secondary outcomes

  1. Plasma BK viral load clearance rate

    Time frame: 1, 3, 6 months

    Percentage of patients who have negative plasma BK virus at specific time point after randomization

  2. Acute rejection rate

    Time frame: 6 months

  3. Glomerular filtration rate (GFR) change

    Time frame: 3, 6 months

    GFR change at specific timepoint after randomization

  4. Chronicity score in kidney allograft

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

King Chulalongkorn Memorial Hospital

Other

Registry information

Acronym: ELF

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Sep 9, 2020
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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