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Immune cells may predict CMV relapse in kidney transplant patients

NCT ID NCT03339661

Disease control Sponsor: University Hospital, Bordeaux Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at 38 kidney transplant patients who had CMV infection. Researchers wanted to see if measuring a type of immune cell (γδ T cells) could help decide who needs extra medication to prevent the virus from coming back. The goal is to avoid unnecessary drugs while still protecting the transplanted kidney.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

38 people

The number who actually took part.

Started

Nov 2017

Finished

Nov 2020

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: * Male or female over 18 years old without weight or ethnicity criteria, kidney transplant. * Patient affiliated or beneficiary of a social security scheme. * Patient with symptomatic or non-symptomatic CMV infection requiring curative treatment with ganciclovir or valganciclovir. * Free, informed and written consent signed by the participant and the investigator (at the latest, on the day of inclusion and before any examination required by the research). Exclusion Criteria: * Resistance documented to antivirals. * Hemodialysis patient. * Number of polymorphonuclear neutrophils less than 500 / μL and / or number of platelets less than 25,000 / μL, and / or lower hemoglobin 8 g / dL. * Contraindication to valganciclovir, including known hypersensitivity to valganciclovir and / or aciclovir and / or valaciclovir or ganciclovir or their excipients, known severe intolerance to valganciclovir or ganciclovir. * Women of childbearing age without a negative pregnancy test at baseline and without effective contraception (estrogen-progestin, intrauterine device) throughout the study period and two months after cessation of the follow-up period. * Nursing women. * Men without mechanical contraception during treatment and for at least 90 days after treatment. * Ongoing participation in another clinical trial evaluating a drug. Participation in an observational study will not be considered a contraindication. * The patient's foreseeable inability to comply with planned visits in the protocol. * Non-negativation of CMV PCR at 8 weeks

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Conditions

The condition(s) this trial relates to.

cytomegalovirus infection renal infectious disease

As listed by the trial registrant

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

Kidney transplant infection

Contacts and locations

Locations

  • Hôpital Edouard Herriot - Hospices Civils de Lyon

    Lyon, 69003, France

  • Hôpital Pellegrin - CHU de Bordeaux

    Bordeaux, 33000, France

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