Validating Injury to the Renal Transplant Using Urinary Signatures in Children

The Validating Injury to the Renal Transplant Using Urinary Signatures in Children (VIRTUUS) observational study includes three specific aims:

• To validate highly sensitive and specific adult urinary mRNA signatures to assess allograft injury in pediatric recipients
• To evaluate the clinical efficacy of urine metabolite profiling to identify and characterize albumin-to-creatinine ratio (ACR) in pediatric recipients
• To validate the sensitivity and specificity of a combined adult renal allograft urinary mRNA and metabolite signature in pediatric recipients to characterize ACR.

These aims will be achieved through the collaborative effort of key pediatric kidney transplant programs across the United States and Canada, supported by two outstanding labs at Cornell and Stanford. This study’s results will advance the ability to identify and characterize early allograft injury in pediatric renal allograft recipients through non-invasive immune surveillance. By doing so, researchers will create opportunities to better inform clinical decision-making, improving practice paradigms to promote positive long-term graft outcomes.

Additionally, VIRTUUS investigators will create and maintain a DNA database abstracted from saliva, blood, and tissue samples collected throughout the study. This database will be used for ancillary studies.