Allosure in Simultaneous Pancreas Kidney Transplant

  • STATUS
    Recruiting
  • End date
    Dec 31, 2025
  • participants needed
    50
  • sponsor
    Washington University School of Medicine
Updated on 1 May 2022

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

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.

Details
Condition Kidney Pancreas Transplant
Treatment DD-cfDNA
Clinical Study IdentifierNCT04777617
SponsorWashington University School of Medicine
Last Modified on1 May 2022

Eligibility

Yes No Not Sure

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
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