Actively Recruiting
Advancing Transplantation Outcomes in Children (CTOT-41)
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-05-20
200
Participants Needed
20
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of two different immunosuppressive drug regimens in children and young adults who have received a kidney transplant. This pediatric study focuses on comparing a treatment combining belatacept and sirolimus with a standard regimen of tacrolimus and Mycophenolate Mofetil (MMF). The trial aims to improve transplant outcomes and is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID). Participants will be randomly assigned within 24 hours after their transplant to one of two groups. One group will receive antithymocyte globulin (ATG), a steroid taper, belatacept infusions, a short tacrolimus bridge, and then switch to sirolimus around one month after transplant. The other group will receive ATG, a steroid taper, tacrolimus, and MMF. Belatacept is given intravenously on a scheduled timeline up to 24 months, and sirolimus dosing depends on participant weight. During the 12 to 24 months of follow-up, participants will have regular assessments including blood tests for donor-specific antibodies and kidney function, as well as biopsies to detect graft rejection and infections. Researchers will monitor adverse events and track outcomes such as infection rates and transplant complications. The study includes detailed lab monitoring and aims to measure the incidence of transplant-related complications up to 96 weeks post-transplant.
CONDITIONS
Brief Title
Advancing Transplantation Outcomes in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant and/or parent/guardian must understand and provide informed consent
- Male or female, 13 to 20 years old at enrollment
- Candidate for first kidney transplant from living or deceased donor
- EBV IgG seropositive showing acquired immunity
- EBV VCA IgM seronegative or seropositive on two occasions 3 months apart with undetectable EBV PCR within 1 month prior
- Negative pregnancy test for females of childbearing potential before procedures
- Agreement to use FDA-approved birth control during the study if of reproductive potential
- Negative test for latent tuberculosis within 12 months
- Up-to-date vaccinations per CDC and transplant trial guidelines
You will not qualify if you...
- Inability or unwillingness to follow study protocol
- Active infection needing treatment or viremia
- History of cancer
- Recent live attenuated vaccine within 4 weeks
- Previous organ transplant
- Listed for multi-organ transplant
- Active systemic autoimmune disease at enrollment
- Specific kidney diseases at risk for recurrence
- Use of immunosuppressants, biologics, corticosteroids, or investigational drugs within 8 weeks before enrollment
- Known bleeding disorders or low platelet count
- History of inherited blood clotting disorders requiring therapy beyond aspirin
- Panel Reactive Antibody (cPRA) greater than 80%
- Significant unrepaired congenital heart disease
- Uncontrolled psychiatric disorders or substance abuse affecting study compliance
- Other medical issues posing risk or affecting data quality as judged by investigator
- Sustained abnormal white blood cell or liver function tests before randomization
- Positive pregnancy test within 48 hours of randomization for females of childbearing potential
- Anti-HLA antibody to donor prior to randomization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months post-transplant
Participants receive antithymocyte globulin (ATG) induction and are randomized to one of two treatment groups. Group 1 transitions from tacrolimus to sirolimus therapy around day 14 to 30 post-transplant with belatacept infusions for up to 24 months. Group 2 receives tacrolimus and mycophenolate mofetil (MMF) throughout treatment.
Multiple visits including belatacept infusions on post-operative days 1, 5, 14, 28, 56, 84, then every 4 weeks starting month 4; regular monitoring visits for medication adjustments
Duration - Up to 96 weeks post-transplant
Participants are monitored for safety and transplant outcomes after completion of treatment up to the primary completion timepoint.
Visits as scheduled for assessments and safety monitoring
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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