Allosure in Simultaneous Pancreas Kidney Transplant

Assessment of Donor Derived Cell-free DNA in Combined Kidney-pancreas Recipients

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04777617

Enrollment

Registered

2021-03-02

Start date

2021-02-26

Completion date

2024-07-31

Last updated

2024-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Pancreas Transplant

Keywords

Kidney pancreas transplant, Deceased donor cell free DNA

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.

Interventions

OTHERDD-cfDNA

We are obtaining samples for donor derived cell free DNA in an observational manner. There is no intervention in this study

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
DD-cfDNA level	1 year	determine level of donor derived cell free DNA from SPK patients

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026