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

Primary Purpose

Kidney Transplant Infection, BK Virus Infection

Status
Recruiting
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Everolimus
reduced dose tacrolimus
Sponsored by
King Chulalongkorn Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Transplant Infection focused on measuring Kidney Transplantation, mTOR inhibitor, Leflunomide, BK virus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • King Chulalongkorn Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

mTORi with reduced-dose tacrolimus

reduced-dose tacrolimus

Arm Description

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.

Patient will receive tacrolimus with target concentration of 3-6 ng/mL with or without 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.

Outcomes

Primary Outcome Measures

Plasma BK viral load change
3-month plasma BK viral load change from randomization

Secondary Outcome Measures

Plasma BK viral load clearance rate
Percentage of patients who have negative plasma BK virus at specific time point after randomization
Acute rejection rate
Glomerular filtration rate (GFR) change
GFR change at specific timepoint after randomization
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)

Full Information

First Posted
August 27, 2020
Last Updated
November 10, 2022
Sponsor
King Chulalongkorn Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04542733
Brief Title
The Efficacy of Everolimus With Reduced-dose Tacrolimus Versus Reduced-dose Tacrolimus in Treatment of BK Virus Infection in Kidney Transplantation Recipient
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 10, 2021 (Actual)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Chulalongkorn Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Transplant Infection, BK Virus Infection
Keywords
Kidney Transplantation, mTOR inhibitor, Leflunomide, BK virus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
mTORi with reduced-dose tacrolimus
Arm Type
Active Comparator
Arm Description
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.
Arm Title
reduced-dose tacrolimus
Arm Type
Active Comparator
Arm Description
Patient will receive tacrolimus with target concentration of 3-6 ng/mL with or without 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.
Intervention Type
Drug
Intervention Name(s)
Everolimus
Intervention Description
Everolimus will be given with tacrolimus.
Intervention Type
Drug
Intervention Name(s)
reduced dose tacrolimus
Intervention Description
Reduced dose tacrolimus will be given with or without leflunomide
Primary Outcome Measure Information:
Title
Plasma BK viral load change
Description
3-month plasma BK viral load change from randomization
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Plasma BK viral load clearance rate
Description
Percentage of patients who have negative plasma BK virus at specific time point after randomization
Time Frame
1, 3, 6 months
Title
Acute rejection rate
Time Frame
6 months
Title
Glomerular filtration rate (GFR) change
Description
GFR change at specific timepoint after randomization
Time Frame
3, 6 months
Title
Chronicity score in kidney allograft
Description
Banff's criteria for allograft biopsy tissue, focus on ci and ct scores ranging from 0 (no chronicity lesion) to 3 (severe chronicity lesion)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Suwasin Udomkarnjananun, MD, MSc
Phone
+66899679885
Email
suwasin.u@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suwasin Udomkarnjananun, MD, MSc
Organizational Affiliation
Chulalongkorn University
Official's Role
Principal Investigator
Facility Information:
Facility Name
King Chulalongkorn Memorial Hospital
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suwasin Udomkarnjananun, M.D.
Phone
66899679885
Email
suwasin.u@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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