Ignite Creation Date:
2024-05-06 @ 3:50 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04777617
Status:
TERMINATED
Last Update Posted:
2023-04-21
First Post:
2021-02-25
Brief Title:
Allosure in Simultaneous Pancreas Kidney Transplant
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
Assessment of Donor Derived Cell-free DNA in Combined Kidney-pancreas Recipients
Status:
TERMINATED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
slow enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None