Kidney Transplant InfectionELFNCT04542733
The Efficacy of Everolimus With Reduced-dose Tacrolimus Versus Reduced-dose Tacrolimus and Leflunomide in Treatment of BK Virus Infection in Kidney Transplantation Recipient
A study testing Everolimus and reduced dose tacrolimus and Leflunomide in people with Kidney Transplant Infection and BK Virus Infection, run by King Chulalongkorn Memorial Hospital at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant Infection, BK Virus Infection
- What is being tested?
- Everolimus and reduced dose tacrolimus and Leflunomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteThailand
- Study dates
- 15 Jun 2023to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- BK VL >10^5 log
- Previous BKVAN treatment
- Drug hypersensitivity to mTORi or leflunomide
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Everolimus, reduced dose tacrolimus and Leflunomide
- Keywords
- Kidney Transplantation, mTOR inhibitor, Leflunomide, BK virus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EverolimusDrug
Everolimus will be given with tacrolimus.
reduced dose tacrolimus and LeflunomideDrug
Reduced dose tacrolimus will be given with leflunomide
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: reduced dose tacrolimus and Leflunomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma BK viral load change
6-month plasma BK viral load change from randomization
Measured: 6 months
Secondary outcomes (4)
Plasma BK viral load clearance rate
Percentage of patients who have negative plasma BK virus at specific time point after randomization
Measured: 1, 3, 6 months
Acute rejection rate
Measured: 6 months
Glomerular filtration rate (GFR) change
GFR change at specific timepoint after randomization
Measured: 3, 6 months
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)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start15 Jun 2023
- Primary completion31 Dec 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Chulalongkorn Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suwasin Udomkarnjananun, King Chulalongkorn Memorial Hospital
- Investigators
- Suwasin Udomkarnjananun, MD, MSc, Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04542733
- Sponsor's protocol ID
- CUKT02/63
- Acronym
- ELF
- Status last verified
- May 2026
- First submitted
- 27 Aug 2020
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Everolimus With Reduced-dose Tacrolimus Versus Reduced-dose Tacrolimus and Leflunomide in Treatment of BK Virus Infection in Kidney Transplantation Recipient
- ClinicalTrials.gov ID
- NCT04542733
- Acronym / sponsor ID
- ELF / CUKT02/63
- Conditions
- Kidney Transplant Infection, BK Virus Infection
- Keywords
- Kidney Transplantation, mTOR inhibitor, Leflunomide, BK virus
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- King Chulalongkorn Memorial HospitalUniversity, hospital or other
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 9 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| mTORi with reduced-dose tacrolimus | Active comparator | Drug: EverolimusPatient 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. |
| reduced-dose tacrolimus and Leflunomide | Active comparator | Drug: reduced dose tacrolimus and LeflunomidePatient 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- BK VL >10^5 log
- Previous BKVAN treatment
- Drug hypersensitivity to mTORi or leflunomide
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EverolimusEverolimus will be given with tacrolimus. | Drug | mTORi with reduced-dose tacrolimus |
| reduced dose tacrolimus and LeflunomideReduced dose tacrolimus will be given with leflunomide | Drug | reduced-dose tacrolimus and Leflunomide |
Primary outcome
Plasma BK viral load change
Time frame: 6 months
6-month plasma BK viral load change from randomization
4 secondary outcomes
Plasma BK viral load clearance rate
Time frame: 1, 3, 6 months
Acute rejection rate
Time frame: 6 months
Glomerular filtration rate (GFR) change
Time frame: 3, 6 months
Chronicity score in kidney allograft
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suwasin Udomkarnjananun, MD, MSc principal investigator
Chulalongkorn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Everolimus and reduced dose tacrolimus and Leflunomide in people with Kidney Transplant Infection and BK Virus Infection, run by King Chulalongkorn Memorial Hospital at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma BK viral load change (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.