NCT04777617

Allosure in Simultaneous Pancreas Kidney Transplant

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 13 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

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

Detailed description

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.

Conditions

• Kidney Pancreas Transplant

Interventions

Type	Name	Description
OTHER	DD-cfDNA	We are obtaining samples for donor derived cell free DNA in an observational manner. There is no intervention in this study

Timeline

• Start date: 2021-02-26
• Primary completion: 2024-07-31
• Completion: 2024-07-31
• First posted: 2021-03-02
• Last updated: 2024-08-07

Locations

1 site across 1 country: United States