Donor-Derived Cell-Free DNA for Surveillance in Simultaneous Pancreas and Kidney Transplant Recipients

2019-10-23 13:11:48 | BioPortfolio


The AlloSure test is approved by the FDA for use in Medicare patients to assess the probability of allograft rejection in kidney transplant patients. The pivotal DART study discusses the use of the non-invasive AlloSure test to measure donor derived cell-free DNA (dd-cfDNA) and the Allosure test can by used to discriminate active rejection in renal transplant patients. Pancreas allograft rejection still remains a major clinical challenge and is a primary cause of death censored pancreas allograft loss. Pancreas transplant rejection is diagnosed by biopsy, however it is not commonly performed because of the complications such as pancreatic leak, graft loss and patient death. Currently at Rush surveillance biopsy of the pancreas are not performed routinely due to the above risks.

At RUMC, patients are followed post-transplant with series of labs at set intervals that include lipase, DSA, C-Peptide, and GAD65 for surveillance of rejection

The AlloSure test was introduced for routine use in kidney transplant recipients at Rush University Medical Center in October 2017, after FDA approval and then as part of the KOAR Study in May of 2018. AlloSure test has been included as part of the routine labs for surveillance of rejection in pancreas transplant recipients at RUMC since September 2018 after it was approved for compassionate use. The addition of AlloSure has helped to improve surveillance of rejection in pancreas transplant recipients and has reduced the need for the kidney biopsy as a surrogate marker of rejection in the pancreas.

Our goal is to determine if AlloSure can be used for surveillance for rejection in recipients of Simultaneous Pancreas and Kidney (SPK) Transplant recipients.


This is a prospective and retrospective cohort study of recipients of simultaneous pancreas and kidney transplant recipients (SPK).

Newly transplanted patients and those within 2 years of SPK transplant will be enrolled in the study, expected duration of participation will therefore range from a minimum of 1 year to a maximum of 3 years for each participant.

The visits are incorporated into the current standard of care in our program and no extra visits are required. Mobile draw for AlloSure can be obtained if the patient is not due for a visit when the AlloSure draw is due.

AlloSure labs will be drawn on all new SPK patients and results obtained as well as retrospective results that have already been received on past SPK recipients. The AlloSure will be added to the standard of care schedule for all SPK patients.

The schedule that we will follow will be the following:

Visit one: 14 days post op

Visit two: 30 days post op

Subsequently subjects will be checked every month until 1 year post transplant

Subjects will be checked every 3 months from 1 year to 3 years post-transplant.

Study Design


Pancreas Transplant Rejection


Allosure Test


Not yet recruiting


Rush University Medical Center

Results (where available)

View Results


Published on BioPortfolio: 2019-10-23T13:11:48-0400

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Medical and Biotech [MESH] Definitions

An immune response with both cellular and humoral components, directed against an allogeneic transplant, whose tissue antigens are not compatible with those of the recipient.

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A group of antigens that includes both the major and minor histocompatibility antigens. The former are genetically determined by the major histocompatibility complex. They determine tissue type for transplantation and cause allograft rejections. The latter are systems of allelic alloantigens that can cause weak transplant rejection.

Non-acceptance, negative attitudes, hostility or excessive criticism of the individual which may precipitate feelings of rejection.

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