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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Sirolimus
DrugParticipants 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
Biological/VaccineBelatacept 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
DrugMycophenolate Mofetil-MMF will be initiated at 600 mg/m\^2 BID until tacrolimus is at therapeutic levels, then 450 mg/m\^2 BID
Tacrolimus (Group1)
DrugParticipants 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
Anti-Thymocyte Globulin (ATG)
DrugParticipants 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
Tacrolimus (Group 2)
DrugParticipants will receive Prograf® (tacrolimus), or generic, initiated at 0.1 mg/kg BID within 48 hours of transplantation to attain target trough levels
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: (Group 1): Belatacept+Sirolimus groupExperimental treatment 4 interventions
Group B: (Group 2): Tacrolimus + Mycophenolate Mofetil (MMF) groupActive comparator 3 interventions
Trial outcomes
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)
Time frame
At 96 weeks post-transplantSecondary outcomes
1
Incidence of clinical biopsy proven allograft rejection (central lab)
Time frame
Within 96 weeks post-transplant2
Time to development of clinical biopsy proven allograft rejection (central lab)
Time frame
Within 96 weeks post-transplant3
Incidence of subclinical biopsy proven allograft rejection (central lab)
Time frame
Within 96 weeks post-transplant4
Time to development of subclinical biopsy proven allograft rejection (central lab)
Time frame
Within 96 weeks post-transplantSponsors and contacts
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Source ClinicalTrials.gov