Advancing Transplantation Outcomes in Children
ADVANTage
1 other identifier
interventional
200
1 country
20
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2024
Typical duration for phase_2
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 20, 2023
CompletedFirst Posted
Study publicly available on registry
September 28, 2023
CompletedStudy Start
First participant enrolled
May 22, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2028
March 2, 2026
February 1, 2026
4.1 years
September 20, 2023
February 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of de novo Donor Specific Antibody (dnDSA) (central lab) OR decline in estimated glomerular filtration rate (eGFR) >7.5 mL/min/1.73m^2 (central lab)
At 96 weeks post-transplant
Secondary Outcomes (8)
Incidence of clinical biopsy proven allograft rejection (central lab)
Within 96 weeks post-transplant
Time to development of clinical biopsy proven allograft rejection (central lab)
Within 96 weeks post-transplant
Incidence of subclinical biopsy proven allograft rejection (central lab)
Within 96 weeks post-transplant
Time to development of subclinical biopsy proven allograft rejection (central lab)
Within 96 weeks post-transplant
Incidence of Post-Transplant Lymphoproliferative Disease (PTLD)
Within 96 weeks post-transplant
- +3 more secondary outcomes
Study Arms (2)
(Group 1): Belatacept+Sirolimus group
EXPERIMENTALParticipants in this group will receive antithymocyte globulin (ATG) + steroid taper + belatacept + (tacrolimus bridge, day 0-14) with conversion to sirolimus (day 30 +/-14 days)
(Group 2): Tacrolimus + Mycophenolate Mofetil (MMF) group
ACTIVE COMPARATORParticipants in this group will receive anti-thymocyte globulin (ATG) + steroid taper + tacrolimus + MMF
Interventions
Participants in Group 1 will transition to sirolimus therapy on day 14 (+/- 5 days) - weight \<40 kg will receive 3mg/m\^ 2, with maintenance dose of 1 mg/m\^2 divided BID - weight \>= 40kg will receive 6mg/m\^ 2, with maintenance dose of 2 mg daily
Belatacept will be administered as an intravenous infusion over 30 minutes. The belatacept dose for the study is 10 mg/kg on post-operative day (POD) 1, 5, 14, 28, 56, 84 for the first 3 months, followed by 5 mg/kg every 4 weeks (+/-4 days), starting on month 4 until month 24
Mycophenolate Mofetil-MMF will be initiated at 600 mg/m\^2 BID until tacrolimus is at therapeutic levels, then 450 mg/m\^2 BID
Participants will receive Prograf® (tacrolimus), or generic, initiated at 0.1 mg/kg BID within 48 hours of transplantation to attain target trough levels. Participants in Group 1 will be transitioned to sirolimus 2-4 weeks post-transplant
Participants will receive induction therapy with anti-thymocyte globulin (1.5 mg/kg/dose, maximum 125 mg) starting intraoperatively on day 0 and continuing on days 2 and 3 (total dose 4.5 mg/kg). Total dose may be extended to 6 mg/kg over 1-2 days for delayed graft function
Participants will receive Prograf® (tacrolimus), or generic, initiated at 0.1 mg/kg BID within 48 hours of transplantation to attain target trough levels
Eligibility Criteria
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
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
- +15 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
University of Alabama at Birmingham (Site # 71038)
Birmingham, Alabama, 35233, United States
Children's Hospital of Los Angeles (Site #: 71036)
Los Angeles, California, 90027, United States
Cedars-Sinai Medical Center (Site #: 71026)
Los Angeles, California, 90048, United States
Mattel Children's Hospital, UCLA (Site #: 71012)
Los Angeles, California, 90095, United States
UCSD Rady Children's Hospital (Site #: 71037)
San Diego, California, 92123, United States
Children's Hospital of Colorado (Site #: 71019)
Aurora, Colorado, 80045, United States
Nemours Children's Health (Site #: 71042)
Wilmington, Delaware, 19803, United States
Children's National Medical Center (Site #: 71039)
Washington D.C., District of Columbia, 20010, United States
Ann and Robert H. Lurie Children's Hospital of Chicago (Site #: 71016)
Chicago, Illinois, 60611, United States
Johns Hopkins Children's Center (Site #: 71025)
Baltimore, Maryland, 21287, United States
Boston Children's Hospital (Site #: 71001)
Boston, Massachusetts, 02215, United States
Helen DeVos Children's Hospital (Site #: 71035)
Grand Rapids, Michigan, 49503, United States
Washington University/St. Louis Children's Hospital (Site #: 71006)
St Louis, Missouri, 63110, United States
New York Medical College/Boston Children's Health Physicians
Westchester, New York, 10461, United States
Duke University (Site #: 71033)
Durham, North Carolina, 27710, United States
Cincinnati Children's Hospital Medical Center (Site #: 71017)
Cincinnati, Ohio, 45229, United States
Children's Hospital of Philadelphia (Site #: 71091)
Philadelphia, Pennsylvania, 19104, United States
UPMC Children's Hospital of Pittsburgh (Site #: 71008)
Pittsburgh, Pennsylvania, 15224, United States
Texas Children's Hospital (Baylor) (Site #: 71005)
Houston, Texas, 77030, United States
Seattle Children's Hospital (Site #: 71041)
Seattle, Washington, 98105, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
David Briscoe, MD
Boston Children's Hospital: Pediatric Transplantation
- STUDY CHAIR
Eileen Chambers, MD
Duke University Medical Center: Department of Pediatrics
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 2023
First Posted
September 28, 2023
Study Start
May 22, 2024
Primary Completion (Estimated)
June 30, 2028
Study Completion (Estimated)
June 30, 2028
Last Updated
March 2, 2026
Record last verified: 2026-02