NCT04130685

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 48 (actual)
• Sponsor: Rush University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The AlloSure test is approved by the Centers for Medicare \& Medicaid Services (CMS) 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 CMS 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.

Detailed description

This is a prospective and retrospective cohort study of recipients of simultaneous pancreas and kidney transplant recipients (SPK). New SPK transplant recipients and previous SPK transplant recipients from September 2012 will be enrolled in the study, expected duration of participation will therefore range from a minimum of 1 year to a maximum of 5 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 will be the following: For newly transplanted patients, AlloSure will be checked at 14 days post-transplant For all subjects: From 1 month to 12 months post transplant: AlloSure will be obtained monthly with their transplant date as the reference time point From 12 months to 36 months: AlloSure will be obtained every 3 months From 36 months to 60 months: AlloSure will be obtained every 6 months. AlloSure may be obtained more frequently than the above schedule, with other clinical data or allograft biopsy, if there is graft dysfunction or suspicion for rejection.

Conditions

• Pancreas Transplant Rejection
• Kidney Transplant Rejection

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Allosure Test	Venous Blood Draw

Timeline

• Start date: 2020-01-15
• Primary completion: 2021-05-31
• Completion: 2022-12-01
• First posted: 2019-10-17
• Last updated: 2022-12-02

Locations

1 site across 1 country: United States