Allosure in Simultaneous Pancreas Kidney Transplant
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- STATUS
- Recruiting
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- End date
- Dec 31, 2025
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- participants needed
- 50
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- sponsor
- Washington University School of Medicine
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 Identifier | NCT04777617 |
| Sponsor | Washington University School of Medicine |
| Last Modified on | 1 May 2022 |
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