ADVANCING TRANSPLANTATION OUTCOMES IN CHILDREN
Primary Objective
To compare whether de novo use of belatacept and sirolimus versus tacrolimus and MMF maintenance therapy will prevent the development of DSA or maintain optimal graft function (eGFR).
Description
This is a phase II, multi-center, open label, randomized controlled trial comparing the safety and efficacy of an immunosuppressive regimen of belatacept and sirolimus to tacrolimus and MMF in pediatric kidney transplant recipients.
Details
Age
All Ages
Eligibility
13-20 years of age and candidate for primary renal allograft from a deceased donor. EBV IgG Seropositive, TB negative, and agreeable to use of FDA approved contraception for study duration.Can't have a diagnosis or history of: Malignancy, anti-HLA antibody to donor, cPRA > 80%, prior history of organ transplant, active systemic autoimmune diseases, idiopathic FSGS, MPGN, C3G, or aHUS, known bleeding disorder, platelet counnt < 75,000 cells/μl, sustained abnormally high liver function tests, or a sustained WBC <1500 or >20,000 per microliter within 3 months of randomization.
Locations
Childrens Hospital Colorado
Principal Investigator
Margret Bock
Study ID
Protocol Number: 23-1536
Categories
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