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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

NCT ID: NCT04542733

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-10

Study Completion Date

2026-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Kidney Transplant Infection BK Virus Infection

Keywords

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Kidney Transplantation mTOR inhibitor Leflunomide BK virus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

All patients met inclusion criteria will be randomized after BK VL not respond to mycophenolic acid and tacrolimus reduction as a run-in phase for 1 month. The intervention arms include everolimus + reduced dose tacrolimus and leflunomide + reduced dose tacrolimus.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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mTORi with reduced-dose tacrolimus

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.

Group Type ACTIVE_COMPARATOR

Everolimus

Intervention Type DRUG

Everolimus will be given with tacrolimus.

reduced-dose tacrolimus and Leflunomide

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.

Group Type ACTIVE_COMPARATOR

reduced dose tacrolimus and Leflunomide

Intervention Type DRUG

Reduced dose tacrolimus will be given with leflunomide

Interventions

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Everolimus

Everolimus will be given with tacrolimus.

Intervention Type DRUG

reduced dose tacrolimus and Leflunomide

Reduced dose tacrolimus will be given with leflunomide

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King Chulalongkorn Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Suwasin Udomkarnjananun

Principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Suwasin Udomkarnjananun, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Chulalongkorn University

Locations

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King Chulalongkorn Memorial Hospital

Bangkok, Bangkok, Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Suwasin Udomkarnjananun, MD, MSc

Role: CONTACT

Phone: +66899679885

Email: [email protected]

Facility Contacts

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Suwasin Udomkarnjananun, M.D.

Role: primary

Other Identifiers

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CUKT02/63

Identifier Type: -

Identifier Source: org_study_id