Status:
RECRUITING
Advancing Transplantation Outcomes in Children
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Kidney Transplant
Eligibility:
All Genders
13-20 years
Phase:
PHASE2
Brief Summary
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 par...
Eligibility Criteria
Inclusion
- 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 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
- If a female participant of childbearing potential, a negative pregnancy test within 48 hours of enrollment
- 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.
Exclusion
- 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
- 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
- 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.
- EBV VCA IgG and EBV EBNA IgG seropositive, confirmed between enrollment and time of transplant
- EBV VCA IgM seronegative, confirmed between enrollment and time of transplant
- Randomization
Key Trial Info
Start Date :
May 22 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2028
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06055608
Start Date
May 22 2024
End Date
June 30 2028
Last Update
December 5 2025
Active Locations (20)
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1
University of Alabama at Birmingham (Site # 71038)
Birmingham, Alabama, United States, 35233
2
Children's Hospital of Los Angeles (Site #: 71036)
Los Angeles, California, United States, 90027
3
Cedars-Sinai Medical Center (Site #: 71026)
Los Angeles, California, United States, 90048
4
Mattel Children's Hospital, UCLA (Site #: 71012)
Los Angeles, California, United States, 90095