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Teen kidney transplant patients may get a better drug option

NCT ID NCT04877288

Disease control Sponsor: Bristol-Myers Squibb Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 01, 2026 · Updated 2 times

Summary

This study tests whether switching teen kidney transplant recipients (ages 12-17) from standard immunosuppressants (calcineurin inhibitors) to belatacept (Nulojix) can improve kidney function and medication adherence. About 102 teens who received a kidney transplant at least 6 months ago will be randomly assigned to either switch to belatacept or stay on their current regimen. The main goal is to see if more patients on belatacept have a working kidney with good function after 2 years.

What this could mean

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

Active substance
belatacept (Nulojix)
What this could lead to
If successful, this could offer teen kidney transplant recipients a better-tolerated immunosuppressant that preserves kidney function longer and is easier to stick with.
What could go wrong
This is a Phase 3 trial, but it's relatively small (102 participants) and open-label, which can bias results. Belatacept may not work for everyone and carries risks like infection or rejection.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 102 people

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

Started

Jul 2021

Expected to finish

Jun 2034

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 17 years

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 and female adolescents 12 to less than 18 years of age * Recipients of a renal allograft from a living or deceased donor transplanted at least 6 calendar months prior to enrollment * Receiving a stable regimen of a calcineurin inhibitor (CNI), with mycophenolate mofetil (MMF) or enteric-coated mycophenolate sodium/mycophenolate mofetil (EC-MPS/MPA), with or without daily corticosteroids for ≥ 30 days prior to randomization * Clinically stable renal function during the 12-week period prior to screening, in the opinion of the investigator and based on protocol-defined criteria for proteinuria and estimated glomerular filtration rate (eGFR) * Serologic evidence of past exposure to Epstein-Barr virus (EBV) and current absence of EBV DNA replication at or prior to renal transplantation and during the Screening period * Completion of an initial course of SARS-CoV-2 vaccination per local standard of care, a minimum of 6 weeks prior to enrollment Exclusion Criteria: * Recipients with EBV serostatus negative or unknown at screening or at transplant * Treatment for biopsy-proven acute rejection (BPAR) of any degree of severity within 6 calendar months prior to enrollment * Biopsy-confirmed antibody-mediated acute rejection at any time with the current allograft * Banff 97 grade IIA or higher acute cellular rejection (or equivalent), or treatment with plasmapheresis or rituximab for any acute rejection at any time with the current allograft * Current evidence or past history of active or inadequately treated latent tuberculosis (TB) infection * Previously treated with belatacept or previously enrolled in a belatacept trial with their present allograft Other inclusion/exclusion criteria apply

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As listed by the trial registrant

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

Renal allograft recipients

How to take part

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

  1. The places running it

    16 sites in 7 countries. 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

  • Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universita

    RECRUITING

    Paris, 75019, France

  • Bordeaux University Hospital - Pellegrin-Pediatrics

    RECRUITING

    Bordeaux, 33076, France

  • Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu

    RECRUITING

    Nantes, Loire-Atlantique, 44093, France

  • Emma Children (AMC)

    RECRUITING

    Amsterdam, 1105 AZ, Netherlands

  • Hopital De La Timone

    RECRUITING

    Marseille, 13005, France

  • Hopital Necker

    RECRUITING

    Paris, 75015, France

  • Hospices Civils de Lyon - Hôpital Femme Mère Enfant-néphrologie pédiatrique

    RECRUITING

    Bron, 69677, France

  • Hospital Italiano de Buenos Aires

    RECRUITING

    ABB, Buenos Aires F.D., C1199ABB, Argentina

  • IRCCS Istituto Giannina Gaslini

    RECRUITING

    Genoa, Liguria, 16147, Italy

  • Instituto de Trasplantes y Alta Complejidad

    RECRUITING

    Buenos Aires, 1425, Argentina

  • Local Institution - 0001

    COMPLETED

    Barcelona, 08035, Spain

  • Local Institution - 0003

    COMPLETED

    Seville, 41013, Spain

  • Local Institution - 0008

    COMPLETED

    Manchester, M13 9WL, United Kingdom

  • Local Institution - 0011

    COMPLETED

    Hamburg, 20246, Germany

  • Local Institution - 0012

    COMPLETED

    Rivas-Vaciamadrid, 28523, Spain

  • Local Institution - 0014

    WITHDRAWN

    Washington D.C., District of Columbia, 20010, United States

  • Local Institution - 0017

    WITHDRAWN

    Baltimore, Maryland, 21287, United States

  • Local Institution - 0022

    WITHDRAWN

    Hollywood, Florida, 33021, United States

  • Local Institution - 0024

    WITHDRAWN

    Durham, North Carolina, 27710, United States

  • Local Institution - 0025

    WITHDRAWN

    Cincinnati, Ohio, 45229, United States

  • Local Institution - 0026

    RECRUITING

    Heidelberg, 69120, Germany

  • Local Institution - 0030

    WITHDRAWN

    Milan, 20122, Italy

  • Local Institution - 0033

    WITHDRAWN

    Chicago, Illinois, 60611, United States

  • Local Institution - 0038

    WITHDRAWN

    Seattle, Washington, 98105, United States

  • Local Institution - 0041

    WITHDRAWN

    Los Angeles, California, 90095, United States

  • Local Institution - 0042

    WITHDRAWN

    Birmingham, Alabama, 35233, United States

  • Local Institution - 0043

    WITHDRAWN

    St Louis, Missouri, 63110, United States

  • Local Institution - 0044

    WITHDRAWN

    Boston, Massachusetts, 02115, United States

  • Local Institution - 0045

    WITHDRAWN

    Miami, Florida, 33136, United States

  • Local Institution - 0048

    WITHDRAWN

    Cleveland, Ohio, 44124, United States

  • Local Institution - 0049

    WITHDRAWN

    Atlanta, Georgia, 30322, United States

  • Local Institution - 0052

    WITHDRAWN

    Portland, Oregon, 97239, United States

  • Local Institution - 0061

    WITHDRAWN

    Oslo, N-0027, Norway

  • Ospedale Regina Margherita-S.C Nefrologia, Dialisi e Trapianto Renale

    RECRUITING

    Torino, 10126, Italy

  • Queen's Medical Centre, Nottingham University Hospitals-Children's Clinical Research Team

    RECRUITING

    Nottingham, NG7 2UH, United Kingdom

  • UZ Gent-Paediatric Nephrology and Rheumatology Department

    RECRUITING

    Ghent, 9000, Belgium

  • Universitaetsklinikum Essen

    RECRUITING

    Essen, North Rhine-Westphalia, 45122, Germany

  • Universitaetsklinikum Koeln-Klinik und Poliklinik für Kinder- und Jugendmedizin, Abteilung für Pädia

    RECRUITING

    Cologne, 50937, Germany

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