Actively Recruiting
Advancing Transplantation Outcomes in Children
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-05-14
200
Participants Needed
20
Research Sites
214 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Advancing Transplantation Outcomes in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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, shown by presence of IgG antibodies to viral capsid antigen and nuclear antigen
- EBV VCA IgM seronegative or seropositive on two occasions at least 3 months apart with undetectable EBV PCR within 1 month prior to enrollment
- If female of childbearing potential, negative pregnancy test before study procedures
- If participant has reproductive potential, agrees to use FDA-approved birth control during the study
- Negative test for latent tuberculosis infection within 12 months
- Vaccinations up to date per CDC and transplant trial guidelines
You will not qualify if you...
- Inability or unwillingness to comply with study protocol
- Active infection requiring treatment or viremia
- History of malignancy
- Receipt of live attenuated vaccine within 4 weeks of enrollment
- Prior history of organ transplantation
- Listed for multi-organ transplant
- Active systemic autoimmune disease at enrollment
- Certain kidney diseases suspected at risk for recurrence
- Use of immunosuppressants, biologics, corticosteroids, or investigational drugs within 8 weeks of enrollment
- Known bleeding disorder or platelet count below 75,000 within 3 months
- History of inherited hypercoagulability requiring therapy beyond aspirin
- Panel Reactive Antibody greater than 80 percent
- Clinically significant unrepaired congenital heart disease
- Uncontrolled psychiatric disorder or substance abuse interfering with study compliance
- Any other medical problems posing added risk or impacting study data quality
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 20 locations
1
University of Alabama at Birmingham (Site # 71038)
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Children's Hospital of Los Angeles (Site #: 71036)
Los Angeles, California, United States, 90027
Not Yet Recruiting
3
Cedars-Sinai Medical Center (Site #: 71026)
Los Angeles, California, United States, 90048
Actively Recruiting
4
Mattel Children's Hospital, UCLA (Site #: 71012)
Los Angeles, California, United States, 90095
Actively Recruiting
5
UCSD Rady Children's Hospital (Site #: 71037)
San Diego, California, United States, 92123
Actively Recruiting
6
Children's Hospital of Colorado (Site #: 71019)
Aurora, Colorado, United States, 80045
Actively Recruiting
7
Nemours Children's Health (Site #: 71042)
Wilmington, Delaware, United States, 19803
Actively Recruiting
8
Children's National Medical Center (Site #: 71039)
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
9
Ann and Robert H. Lurie Children's Hospital of Chicago (Site #: 71016)
Chicago, Illinois, United States, 60611
Actively Recruiting
10
Johns Hopkins Children's Center (Site #: 71025)
Baltimore, Maryland, United States, 21287
Actively Recruiting
11
Boston Children's Hospital (Site #: 71001)
Boston, Massachusetts, United States, 02215
Actively Recruiting
12
Helen DeVos Children's Hospital (Site #: 71035)
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
13
Washington University/St. Louis Children's Hospital (Site #: 71006)
St Louis, Missouri, United States, 63110
Actively Recruiting
14
New York Medical College/Boston Children's Health Physicians
Westchester, New York, United States, 10461
Not Yet Recruiting
15
Duke University (Site #: 71033)
Durham, North Carolina, United States, 27710
Actively Recruiting
16
Cincinnati Children's Hospital Medical Center (Site #: 71017)
Cincinnati, Ohio, United States, 45229
Actively Recruiting
17
Children's Hospital of Philadelphia (Site #: 71091)
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
18
UPMC Children's Hospital of Pittsburgh (Site #: 71008)
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
19
Texas Children's Hospital (Baylor) (Site #: 71005)
Houston, Texas, United States, 77030
Actively Recruiting
20
Seattle Children's Hospital (Site #: 71041)
Seattle, Washington, United States, 98105
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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