Advancing Transplantation Outcomes in Children

Recruiting now · Phase 2

Conditions studied: Kidney Transplant

In brief

This is a pediatric kidney transplant study comparing the safety and efficacy of an immunosuppressive regimen of belatacept and sirolimus to tacrolimus and Mycophenolate Mofetil (MMF). Two hundred participants will be randomized (1:1) to one of two groups within 24 hours following the transplant procedure. The duration of the study from time of transplant to the primary endpoint is 12-24 months.

Key facts

Study ID: NCT06055608
Run by: National Institute of Allergy and Infectious Diseases (NIAID)
People needed: 200
Starts: 2024-05-22
Expected to finish: 2028-06-30
Last updated by the study team: 2026-05-20

Who can join

Age: 13 and older, up to 20. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Participant and/or parent/guardian must be able to understand and provide informed consent
Male or female, 13-20 years of age at time of enrollment
Candidate for primary renal allograft from a living or deceased donor
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)
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
If a female participant of childbearing potential, a negative pregnancy test prior to conducting any study procedures
If participant has reproductive potential, agrees to use Food and Drug Administration (FDA) approved methods of birth control for the duration of the study
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
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.

You may not qualify if…

Inability or unwillingness to comply with study protocol
Active infection requiring treatment, or viremia
History of malignancy
Receipt of any licensed or investigational live attenuated vaccine(s) within 4 weeks of enrollment
Prior history of organ transplantation
Listed for multi-organ transplant (e.g. heart- kidney, liver-kidney, multivisceral- kidney, lung- kidney)
Active systemic autoimmune disease at time of enrollment
Idiopathic Focal Segmental Glomerulosclerosis (FSGS), Membranoproliferative Glomerulonephritis (MPGN), C3 glomerulopathy, or atypical Hemolytic Uremic Syndrome (HUS) suspected at risk for recurrence
Use of immunosuppressants, biologics (including IVIG), chronic corticosteroids or investigational drug(s) within 8 weeks of enrollment
Known bleeding disorder
Sustained platelet count < 75,000 cells/microliters within 3 months of enrollment
History of inherited hypercoagulability requiring therapy more than aspirin
Panel Reactive Antibody (cPRA) greater than 80 percent
Clinically significant unrepaired congenital heart disease causing hemodynamic compromise
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
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.
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.
Sustained WBC <1500 or >20,000 per microliter within 3 months of randomization
Sustained liver function tests (AST and/or ALT) > 2x normal within 3 months of randomization
Active systemic autoimmune disease at time of transplant
Known bleeding disorder

Where it is running

Seattle Children's Hospital (Site #: 71041) — Seattle, Washington, United States (enrolling)
Texas Children's Hospital (Baylor) (Site #: 71005) — Houston, Texas, United States (enrolling)
University of Alabama at Birmingham (Site # 71038) — Birmingham, Alabama, United States (enrolling)
Cedars-Sinai Medical Center (Site #: 71026) — Los Angeles, California, United States (enrolling)
Mattel Children's Hospital, UCLA (Site #: 71012) — Los Angeles, California, United States (enrolling)
UCSD Rady Children's Hospital (Site #: 71037) — San Diego, California, United States (enrolling)
Children's Hospital of Colorado (Site #: 71019) — Aurora, Colorado, United States (enrolling)
Nemours Children's Health (Site #: 71042) — Wilmington, Delaware, United States (enrolling)
Children's National Medical Center (Site #: 71039) — Washington D.C., District of Columbia, United States (enrolling)
Ann and Robert H. Lurie Children's Hospital of Chicago (Site #: 71016) — Chicago, Illinois, United States (enrolling)
Johns Hopkins Children's Center (Site #: 71025) — Baltimore, Maryland, United States (enrolling)
Boston Children's Hospital (Site #: 71001) — Boston, Massachusetts, United States (enrolling)
Helen DeVos Children's Hospital (Site #: 71035) — Grand Rapids, Michigan, United States (enrolling)
Washington University/St. Louis Children's Hospital (Site #: 71006) — St Louis, Missouri, United States (enrolling)
Duke University (Site #: 71033) — Durham, North Carolina, United States (enrolling)
Cincinnati Children's Hospital Medical Center (Site #: 71017) — Cincinnati, Ohio, United States (enrolling)
Children's Hospital of Philadelphia (Site #: 71091) — Philadelphia, Pennsylvania, United States (enrolling)
UPMC Children's Hospital of Pittsburgh (Site #: 71008) — Pittsburgh, Pennsylvania, United States (enrolling)
Children's Hospital of Los Angeles (Site #: 71036) — Los Angeles, California, United States
New York Medical College/Boston Children's Health Physicians — Westchester, New York, United States

Full record on ClinicalTrials.gov

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