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

Kidney Transplant Infection Clinical Trial

— ELF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04542733
• Other study ID #: CUKT02/63
• Status: Recruiting
• Phase: N/A
• Start date: February 10, 2021
• Est. completion date: September 2025

Study information

• Verified date: January 2024
• Source: King Chulalongkorn Memorial Hospital
• Contact: Suwasin Udomkarnjananun, MD, MSc
• Phone: +66899679885
• Email: suwasin.u[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• BK Virus Infection
• Communicable Diseases
• Infections
• Kidney Transplant Infection
• Virus Diseases

Intervention

Drug:
• Everolimus
Everolimus will be given with tacrolimus.
• reduced dose tacrolimus
Reduced dose tacrolimus will be given with or without leflunomide

Locations

Country	Name	City	State
Thailand	King Chulalongkorn Memorial Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
King Chulalongkorn Memorial Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma BK viral load change	3-month plasma BK viral load change from randomization	3 months
Secondary	Plasma BK viral load clearance rate	Percentage of patients who have negative plasma BK virus at specific time point after randomization	1, 3, 6 months
Secondary	Acute rejection rate		6 months
Secondary	Glomerular filtration rate (GFR) change	GFR change at specific timepoint after randomization	3, 6 months
Secondary	Chronicity score in kidney allograft	Banff's criteria for allograft biopsy tissue, focus on ci and ct scores ranging from 0 (no chronicity lesion) to 3 (severe chronicity lesion)	6 months