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New hope for kidney transplant patients: belatacept trial targets hidden rejection

NCT ID NCT06291103

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Updated 1 time

Summary

This study tests whether switching to belatacept (a drug) plus standard care can better treat early antibody-mediated rejection in kidney transplant patients compared to continuing standard care alone. About 290 adults with new donor-specific antibodies but no kidney function decline will be randomly assigned to one of two groups. The goal is to see if belatacept helps prevent graft damage and rejection over 12 months.

What this could mean

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

Active substance
Belatacept
What this could lead to
If successful, this could offer a better way to treat early rejection in kidney transplant patients, potentially improving long-term graft survival.
What could go wrong
This is an early-phase trial with a moderate size, so results may not confirm benefit. Belatacept also requires lifelong use alongside other drugs, and risks include infection and graft loss.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 290 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Aug 2032

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: 1. Screening inclusion criteria: * Kidney transplant recipient * Adult * De novo DSA (MFI \> 1000 using the Luminex single antigen beads assay or positive with the manufacturer criteria according to the Luminex assay) absent on the day of kidney transplantation and in the sera prior to kidney transplantation * No clinical graft dysfunction at time of DSA detection (\< 20 % variation of eGFR compared to last 3 months before detection and \< 0,5 g/g proteinuria/creatinuria ratio) * Affiliation with, or beneficiary of a Social security (national health insurance) category * Person having read and understood the information letter and signed the consent form * Women of childbearing potential with effective contraception/very-effective contraception (Cf. CTFG) (oestro-progestatives or intra-uterine device or tubal ligation) and a negative blood pregnancy test. * Women surgically sterile (absence of ovaries and/or uterus) * Postmenopausal women: confirmation diagnostic (non-medically induced amenorrhea for at least 12 months prior to the inclusion visit) 2. Randomization inclusion criteria: * Patients with active sABMR, according Banff 2019 classification, with very slight transplant glomerulogathy (cg = 0 or 1). Exclusion Criteria: 1. Screening exclusion criteria: * Minor * Specific treatment for DSA occurrence before kidney graft biopsy: IVIG or rituximab or plasmapheresis or immunoabsorption * ABO incompatible kidney transplantation * Combined transplantation * Transplant recipients who are Epstein-Barr virus (EBV) seronegative or serostatus unknown. * Hypersensitivity to the active substance or to any of the excipients - Pregnant or parturient or breastfeeding woman or absence of contraception * Person deprived of liberty by an administrative or judiciary decision or person placed under judicial protection, under guardianship or supervision * Person consenting to the research participating to another trial * Medical history or psychological or sensorial abnormality prone to inhibit the subject to understand the conditions required for his/her participation to the protocol or unable him/her to give an informed consent * No signed ICF 2. Randomization exclusion criteria: * No sABMR or chronic active sABMR (cg \> 1) on initial biopsy * History of severe opportunistic infection before randomization * Acute or chronic infection with HBV, HCV or HIV * EBV negative serology * History of post-transplant lymphoproliferative disorder.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CHU de ROUEN

    Rouen, 76031, France

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