Allosure in Simultaneous Pancreas Kidney Transplant

Assessment of Donor Derived Cell-free DNA in Combined Kidney-pancreas Recipients

This study will observe donor derived cell free DNA percentages (via the Allosure test) in combined kidney-pancreas transplant recipients to establish both stable and dysfunctional Allosure assay levels

Simultaneous kidney-pancreas transplantation is the optimal treatment for select patients with type 1 diabetes and kidney failure. Limited biomarkers are utilized to monitor the health of the allografts. For kidney transplantation serum creatinine remains the most commonly monitored biomarker; for the pancreas allograft blood glucose and serum amylase and lipase are measured. However, these biomarkers are imprecise and non-specific for rejection.

In kidney transplantation cell free donor derived DNA at of value of >1% has emerged as an effective immune monitoring tool as a marker for renal allograft rejection and injury. Thus far, a discriminatory donor derived cell free DNA value for a stable and rejecting allografts has not been established for recipients of combined kidney-pancreas transplants.

Study aim will be to help establish a normal range of donor derived cell free DNA in stable kidney-pancreas graft function in combined kidney pancreas transplant recipients while determining changes in cell free DNA in kidney-pancreas recipients with biopsy proven allograft rejection.

Inclusion Criteria:

• Age ≥18 years
• Kidney-pancreas transplant recipients
• Patient must have stable creatine, lipase, amylase for at least a two month span after transplant OR patient must receive a biopsy within one year post transplant

Exclusion Criteria:

• Presence of non-renal or pancreas transplanted organ
• Patient is not enrolled within 1 year after transplant