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New hope for kidney transplant patients battling BK virus

NCT ID NCT04542733

Disease control Sponsor: King Chulalongkorn Memorial Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at two drug combinations to treat BK virus infection in kidney transplant recipients. BK virus can cause the new kidney to fail. The trial compares everolimus with a lower dose of tacrolimus versus a lower dose of tacrolimus plus leflunomide in 50 adults whose virus did not clear after reducing their usual anti-rejection medicines. The main goal is to see which combination lowers the virus level more over six months.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2023

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

BK-virus nephropathy renal infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

BK virus infection Kidney transplant infection

Contacts and locations

Locations

  • King Chulalongkorn Memorial Hospital

    Bangkok, Bangkok, 10330, Thailand

More trials for these conditions

Other studies related to the condition(s) this trial covers.