Allosure in Simultaneous Pancreas Kidney Transplant

Terminated

• Conditions: Kidney Pancreas Transplant
• Interventions: Other: DD-cfDNA

• Registration Number: NCT04777617
• Lead Sponsor: Washington University School of Medicine

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.

Study Timeline

• Study First Submitted: 2021-02-25
• Study First Submitted QC: 2021-02-25
• Study Start: 2021-02-26
• Study First Posted: 2021-03-02
• Primary Completion: 2024-07-31
• Study Completion: 2024-07-31
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-02
• Last Update Posted: 2024-08-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
WU/Barnes cohort	DD-cfDNA	SPK patients in this group will be recruited from WU/Barnes Transplant center. A total of 25 from this cohort will be recruited and asked to provide a blood sample to test for donor derived cell free DNA 3 times over the course of the first year of transplant. In addition, if any biopsies or rejections occur, additional samples will be requested at the time of biopsy and for an additional two follow-ups at least one month apart.
UT Southwestern cohort	DD-cfDNA	SPK patients in this group will be recruited from WU/Barnes Transplant center. A total of 25 from this cohort will be recruited and asked to provide a blood sample to test for donor derived cell free DNA 3 times over the course of the first year of transplant. In addition, if any biopsies or rejections occur, additional samples will be requested at the time of biopsy and for an additional two follow-ups at least one month apart.

Primary Outcome Measures

Name	Time	Method
DD-cfDNA level	1 year	determine level of donor derived cell free DNA from SPK patients

Trial Locations

Locations (1)

Washington University; 🇺🇸 Saint Louis, Missouri, United States