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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Thailand
King Chulalongkorn Memorial Hospital
RECRUITING
Bangkok
Contact Information
Primary
Suwasin Udomkarnjananun, MD, MSc
suwasin.u@gmail.com
+66899679885
Time Frame
Start Date: 2021-02-10
Estimated Completion Date: 2026-01
Participants
Target number of participants: 50
Treatments
Active_comparator: 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.
Active_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: King Chulalongkorn Memorial Hospital

This content was sourced from clinicaltrials.gov