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Can a simple antibody infusion shield kidney transplants from a sneaky virus?

NCT ID NCT04222023

Prevention 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Aug 21, 2026 · Updated 3 times

Summary

This study tested whether giving intravenous immunoglobulins (IVIG) could prevent BK virus infection in kidney transplant recipients. The virus often causes graft problems. Researchers enrolled 359 patients with low antibody levels against their donor's virus strain and gave some of them three doses of IVIG after transplant. The goal was to see if this reduced the number of patients with high virus levels in the blood six months later.

What this could mean

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

Active substance
Intravenous immunoglobulins (IVIG)
What this could lead to
If it works, this could provide a way to prevent BK virus infection after kidney transplant, reducing the risk of graft loss.
What could go wrong
This is a completed Phase 4 trial, but results are not yet widely reported. The benefit may depend on matching the donor's virus strain, and IVIG can cause side effects like allergic reactions or kidney 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

359 people

The number who actually took part.

Started

Aug 2022

Finished

Aug 2026

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 (\> 18 years) * Kidney transplant recipients, including multiple organ transplant patients * Patients able to understand the purpose and the risks of the study, fully informed and having written informed consent * Negative pregnancy test * Affiliated to a medical insurance scheme Exclusion criteria: * BKV nephropathy during a previous transplantation in the past 5 years * HLA and ABO-incompatible kidney transplant recipients undergoing desensitization with rituximab and/or plasmapheresis before transplantation or susceptible to receive such therapy after transplantation * Patients with high risk of post- transplant Focal Segmental glomerulosclerosis recurrence * Patient with hyperprolinemia * Allergy or known intolerance to IVIG * Pregnant or breast feeding women * Adults under guardianship or limited guardianship * Currently participating in another clinical trial investigating drugs (observational studies are not considered as an exclusion criterion)

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Conditions

The condition(s) this trial relates to.

BK-virus nephropathy prevention target

As listed by the trial registrant

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

Kidney transplantation

Contacts and locations

Locations

  • Les Hôpitaux Universitaires de Strasbourg

    Strasbourg, 67000, France

More trials for these conditions

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