top-bar-logos

CLINICAL TRIALS

Emily Toal, MPH

Clinical Coordinator, Transplant Research Program

Current Clinical Trials

Advancing Transplantation Outcomes in Children (ADVANTage)

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. The primary endpoints are the incidence of de novo Donor Specific Antibody (dnDSA) OR the decline in estimated glomerular filtration rate (eGFR). The duration of the study from time of transplant to the primary endpoint is 12 months (dnDSA) and 24 months (eGFR).

Extensive mechanistic studies will be performed to identify the effects of belatacept and sirolimus on the alloimmune response, protective immune responsiveness, intragraft pro-inflammatory profiles and the attenuation of genomic risk-based assessment.

Biomarker Initiative to Transform Outcomes in Children (BRiTE-c)

This is a collaborative multicenter initiative using biorepository specimens to evaluate biomarkers of outcomes following pediatric transplantation. Members of this consortium have developed a urine biomarker assay for clinical point-of-care use in the monitoring of patients post transplantation. The assay has high specificity to define clinically stable patients and those at low risk for subsequent rejection.  In addition, a new initiative is currently evaluating intragraft transcriptomes in kidney biopsies that can predict immune evasion and/or patients with potential for tolerance.