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Clinical Trial 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


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04777617
Study type Observational
Source Washington University School of Medicine
Contact Rowena Delos Santos
Phone 314-362-8351
Email delossantos@wustl.edu
Status Recruiting
Phase
Start date February 26, 2021
Completion date December 31, 2026

See also
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