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New drug combo may beat BK virus in kidney transplants

NCT ID NCT03216967

Disease control Sponsor: University Hospital, Strasbourg, France 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether switching from one immunosuppressant to everolimus, along with lowering overall immunosuppression, helps clear BK virus better than just lowering immunosuppression alone. The trial involved 130 kidney transplant recipients with BK virus in their blood. The goal was to see if more patients cleared the virus after 6 months while keeping their kidney function stable.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
everolimus
What this could lead to
If successful, this could offer a safer way to clear BK virus after kidney transplant, reducing the risk of kidney damage without increasing rejection.
What could go wrong
This is a completed Phase 4 trial with 130 participants, so results are available but may not apply to all patients. Everolimus can cause side effects like mouth sores, infections, or metabolic issues.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

130 people

The number who actually took part.

Started

Jan 2018

Finished

Aug 2024

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: * Adult patients * Kidney transplant recipients * Patients treated by a calcineurin inhibitor and mycophenolic acid * Viremia \>= 2.8 log UI/ml * Patients who have given written informed consent * Negative pregnancy test (blood β-HCG dosage) Exclusion Criteria: * Known proved BKV nephropathy * Hypersensitivity to everolimus, sirolimus or excipient * Concomitant treatment by leflunomide, cidofovir, sirolimus, Millepertuis (Hypericum Perforatum) * Pregnant or lactating women * Women of child bearing potential unless they are using a birth control method

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Conditions

The condition(s) this trial relates to.

BK-virus nephropathy

As listed by the trial registrant

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

BK virus nephropathy after kidney transplantation

Contacts and locations

Locations

  • AP-HP - Hôpital Georges Pompidou

    Paris, 75908, France

  • AP-HP Hôpital Necker

    Paris, 75743, France

  • CHRU - Hôpital Bretonneau

    Tours, 37044, France

  • CHRU d'Angers

    Angers, 49033, France

  • CHU - Hôpital Dupuytren

    Limoges, 87042, France

  • CHU - Hôpital Maison Blanche

    Reims, 51092, France

  • CHU - Hôpital Sud

    Amiens, 80054, France

  • CHU - Hôpital de la Cavale Blanche

    Bois-Guillaume, 76230, France

  • CHU - Hôpital de la Cavale Blanche

    Brest, 29609, France

  • CHU Côte de Nacre

    Caen, 14033, France

  • CHU Hôpital Gabriel Montpied

    Clermont-Ferrand, 63000, France

  • CHU Poitiers - Hôpital Jean Bernard

    Poitiers, 86021, France

  • CHU Rennes - Hôpital Pontchaillou

    Rennes, 35033, France

  • Hôpital Edouard Herriot

    Lyon, 69003, France

  • Les Hôpitaux Universitaires

    Strasbourg, 67000, France