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Kidney transplant patients' immune response to common virus tracked after drug switch

NCT ID NCT05708534

Knowledge-focused Sponsor: University Hospital, Rouen 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 follows 28 kidney transplant recipients who are switching from one anti-rejection drug (anticalcineurin) to another (belatacept). Researchers want to see how this change affects the immune system's ability to fight the common CMV virus. Participants will have blood tests at the start, 3 months, and 6 months to measure CMV-fighting T-cells.

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.

Participants

About 28 people

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

Started

Nov 2023

Expected to finish

May 2027

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.

Who is studied

Cohort of kidney transplant recipients seropositive for CMV

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: * Renal transplant follow-up at Rouen University Hospital * Clinico-biological intolerance to anticalcineurins defined by GFR \< 25 mL/min and/or water and sodium overload justifying the prescription of loop diuretics and/or post-transplant diabetes and/or resistant hypertension (requiring at least 3 treatments antihypertensives including a thiazide diuretic to reach an objective ≤ 140/90 mmHg). * Having performed a graft biopsy \< 3 months old finding lesions of fibrous endarteritis ≥ 2 or arteriolar hyalinosis ≥ 2 * Having undergone collegial validation for the initiation of treatment with belatacept combined with 3-month anti-CMV prophylaxis with oral Valganciclovir. * Absence of contraindication to belatacept * Patient who has never received belatacept * Having a positive CMV serological status Exclusion Criteria: * Patient with symptomatic infection * Pregnant or parturient or breast-feeding woman or lack of proven effective contraception * Person deprived of liberty by an administrative or judicial decision or person placed under legal safeguard / sub-tutorship or curatorship * Patient participating in another therapeutic trial or having participated in another trial within 1 month

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Conditions

The condition(s) this trial relates to.

pyelonephritis 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

  • University Rouen Hospital

    Rouen, 76031, France

More trials for these conditions

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