Advancing Transplantation Outcomes in Children
ConditionKidney Transplant
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age13-20
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Sirolimus
- Belatacept
- Mycophenolate Mofetil
- Tacrolimus (Group1)
- Anti-Thymocyte Globulin (ATG)
- Tacrolimus (Group 2)
Treatment groups
200 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov