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 | Recruiting DMC

• 1 other identifier: CUKT02/63
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Kidney Transplantation; mTOR inhibitor; Leflunomide; BK virus

Outcome Measures

Primary Outcomes (1)

• Plasma BK viral load change

  3-month plasma BK viral load change from randomization

  3 months

Secondary Outcomes (5)

• Plasma BK viral load clearance rate

  1, 3, 6 months

• Acute rejection rate

  6 months

• Glomerular filtration rate (GFR) change

  3, 6 months

• Chronicity score in kidney allograft

  6 months

• 6-month plasma BK VL

  6 months

Study Arms (2)

mTORi with reduced-dose tacrolimus

ACTIVE COMPARATOR

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.

Drug: Everolimus

reduced-dose tacrolimus and Leflunomide

ACTIVE COMPARATOR

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.

Drug: reduced dose tacrolimus and Leflunomide

Interventions

Everolimus DRUG

Everolimus will be given with tacrolimus.

mTORi with reduced-dose tacrolimus

reduced dose tacrolimus and Leflunomide DRUG

Reduced dose tacrolimus will be given with leflunomide

reduced-dose tacrolimus and Leflunomide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• BK VL \>10\^5 log
• Previous BKVAN treatment
• Drug hypersensitivity to mTORi or leflunomide

Sponsors & Collaborators

• King Chulalongkorn Memorial Hospital: lead

Study Sites (1)

King Chulalongkorn Memorial Hospital

Bangkok, Bangkok, 10330, Thailand

RECRUITING

MeSH Terms

Interventions

Everolimus; Leflunomide

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals; Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Suwasin Udomkarnjananun, MD, MSc

  Chulalongkorn University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suwasin Udomkarnjananun, MD, MSc

CONTACT

+66899679885; suwasin.u@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 27, 2020
• First Posted: September 9, 2020
• Study Start: February 10, 2021
• Primary Completion: December 24, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 31, 2025

Record last verified: 2025-12

Locations

TH (1)