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New hope for young kidney transplant patients: safer drug combo tested

NCT ID NCT06055608

Disease control Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 17, 2026 · Updated 2 times

Summary

This study tests whether a combination of belatacept and sirolimus works better than the standard drugs tacrolimus and MMF in children aged 13-20 who receive a kidney transplant. The goal is to reduce the risk of organ rejection and protect kidney function. Participants are randomly assigned to one of the two drug groups and followed for 12-24 months.

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

About 200 people

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

Started

May 2024

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

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

Ages

13 to 20 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: 1. Participant and/or parent/guardian must be able to understand and provide informed consent 2. Male or female, 13-20 years of age at time of enrollment 3. Candidate for primary renal allograft from a living or deceased donor 4. EBV IgG seropositive, defined as evidence of acquired immunity shown by the presence of IgG antibodies to viral capsid antigen (VCA) and EBV nuclear antigen (EBNA) 5. EBV VCA IgM seronegative OR EBV VCA IgM seropositive on two occasions at least 3 months apart and an undetectable EBV PCR result within 1 month prior to enrollment 6. If a female participant of childbearing potential, a negative pregnancy test prior to conducting any study procedures 7. If participant has reproductive potential, agrees to use Food and Drug Administration (FDA) approved methods of birth control for the duration of the study 8. Negative test result for latent tuberculosis infection by tuberculosis skin test (purified protein derivative \[PPD\]) or Tuberculosis (TB) blood test (interferon gamma release assay \[IGRA\] i.e., QuantiFERON, T- SPOT.TB) within 12 months 9. In the absence of contraindication, vaccinations must be up to date per the Centers for Disease Control and Prevention (CDC) Guidelines and Division of Allergy, Immunology, and Transplantation (DAIT) Guidance for Patients in Transplant Trials Enrollment criteria for donor source and age will be expanded using a stepwise approach determined by safety monitoring. Expansion criteria will include recipients down to age 6 and living donors. Safety data from each step will be reviewed by the study team, DSMB and FDA. If no safety concerns are identified, inclusion criteria will be expanded. Exclusion Criteria: 1. Inability or unwillingness to comply with study protocol 2. Active infection requiring treatment, or viremia 3. History of malignancy 4. Receipt of any licensed or investigational live attenuated vaccine(s) within 4 weeks of enrollment 5. Prior history of organ transplantation 6. Listed for multi-organ transplant (e.g. heart- kidney, liver-kidney, multivisceral- kidney, lung- kidney) 7. Active systemic autoimmune disease at time of enrollment 8. Idiopathic Focal Segmental Glomerulosclerosis (FSGS), Membranoproliferative Glomerulonephritis (MPGN), C3 glomerulopathy, or atypical Hemolytic Uremic Syndrome (HUS) suspected at risk for recurrence 9. Use of immunosuppressants, biologics (including IVIG), chronic corticosteroids or investigational drug(s) within 8 weeks of enrollment 10. Known bleeding disorder 11. Sustained platelet count \< 75,000 cells/microliters within 3 months of enrollment 12. History of inherited hypercoagulability requiring therapy more than aspirin 13. Panel Reactive Antibody (cPRA) greater than 80 percent 14. Clinically significant unrepaired congenital heart disease causing hemodynamic compromise 15. Uncontrolled diagnosed psychiatric disorder or self-reported drug or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements 16. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study Randomization Inclusion Criteria: Individuals who meet all of the following criteria are eligible for randomization. 1\. If EBV serology to meet enrollment criteria was performed within 8 weeks of receiving IVIG, EBV VCA IgG and EBV EBNA IgG seropositivity, confirmed between enrollment and time of transplant Randomization Exclusion Criteria: Individuals who meet any of these criteria are not eligible for randomization. 1. Sustained WBC \<1500 or \>20,000 per microliter within 3 months of randomization 2. Sustained liver function tests (AST and/or ALT) \> 2x normal within 3 months of randomization 3. Active systemic autoimmune disease at time of transplant 4. Known bleeding disorder 5. Sustained platelet count \< 75,000 cells/microliters within 3 months of enrollment 6. Current (within 45 days) or historical anti-HLA antibody to the donor prior to randomization 7. Recent recipient of any licensed or investigational live attenuated vaccine(s) within 4 weeks of randomization 8. Panel Reactive Antibody (cPRA) greater than 80 percent at any point in time 9. If a female participant of childbearing potential, a positive pregnancy test within 48 hours of randomization (all female participants of childbearing potential must complete a pregnancy test within 48 hours of randomization) 10. Treatment with immunosuppressants within 8 weeks of randomization, except in the case of planned transplant standard of care 11. Treatment with biologics (including IVIG) within 8 weeks of randomization

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Conditions

The condition(s) this trial relates to.

end stage renal failure

As listed by the trial registrant

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

Kidney transplant

How to take part

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

  1. The places running it

    21 sites in 2 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

  • Ann and Robert H. Lurie Children's Hospital of Chicago (Site #: 71016)

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Boston Children's Hospital (Site #: 71001)

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • British Columbia Children's Hospital (Site #: 71034)

    RECRUITING

    Vancouver, British Columbia, V5Z 4H4, Canada

  • Cedars-Sinai Medical Center (Site #: 71026)

    RECRUITING

    Los Angeles, California, 90048, United States

  • Children's Hospital of Colorado (Site #: 71019)

    RECRUITING

    Aurora, Colorado, 80045, United States

  • Children's Hospital of Los Angeles (Site #: 71036)

    NOT_YET_RECRUITING

    Los Angeles, California, 90027, United States

  • Children's Hospital of Philadelphia (Site #: 71091)

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Children's National Medical Center (Site #: 71039)

    RECRUITING

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

  • Cincinnati Children's Hospital Medical Center (Site #: 71017)

    RECRUITING

    Cincinnati, Ohio, 45229, United States

  • Duke University (Site #: 71033)

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Helen DeVos Children's Hospital (Site #: 71035)

    RECRUITING

    Grand Rapids, Michigan, 49503, United States

  • Johns Hopkins Children's Center (Site #: 71025)

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • Mattel Children's Hospital, UCLA (Site #: 71012)

    RECRUITING

    Los Angeles, California, 90095, United States

  • Nemours Children's Health (Site #: 71042)

    RECRUITING

    Wilmington, Delaware, 19803, United States

  • New York Medical College/Boston Children's Health Physicians

    NOT_YET_RECRUITING

    Westchester, New York, 10461, United States

  • Seattle Children's Hospital (Site #: 71041)

    RECRUITING

    Seattle, Washington, 98105, United States

  • Texas Children's Hospital (Baylor) (Site #: 71005)

    RECRUITING

    Houston, Texas, 77030, United States

  • UCSD Rady Children's Hospital (Site #: 71037)

    RECRUITING

    San Diego, California, 92123, United States

  • UPMC Children's Hospital of Pittsburgh (Site #: 71008)

    RECRUITING

    Pittsburgh, Pennsylvania, 15224, United States

  • University of Alabama at Birmingham (Site # 71038)

    RECRUITING

    Birmingham, Alabama, 35233, United States

  • Washington University/St. Louis Children's Hospital (Site #: 71006)

    RECRUITING

    St Louis, Missouri, 63110, United States

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