NCT04130685

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

Completed Last updated 2 December 2022

What this trial tests

trial testing Allosure Test in Pancreas Transplant Rejection in 48 participants. Completed in 1 December 2022.

Timeline

15 January 2020

Primary endpoint
31 May 2021

1 December 2022

Quick facts

Lead sponsor	Rush University Medical Center
Status	Completed
Study type	OBSERVATIONAL
Enrollment	48
Start date	15 January 2020
Primary completion	31 May 2021
Estimated completion	1 December 2022
Sites	1 location across United States

Drugs / interventions tested

• Allosure Test

Conditions studied

• Pancreas Transplant Rejection — all drugs for Pancreas Transplant Rejection →
• Kidney Transplant Rejection — all drugs for Kidney Transplant Rejection →

Sponsor

Rush University Medical Center

Who can join

18 and older, any sex, with Pancreas Transplant Rejection or Kidney Transplant Rejection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Emerging role of cell-free DNA in kidney transplantation.
   Chopra B, Sureshkumar KK. · · 2021 · cited 11× · PMID 34877265 · DOI 10.5493/wjem.v11.i5.55
2. Early Experience Using Donor-derived Cell-free DNA for Surveillance of Rejection Following Simultaneous Pancreas and Kidney Transplantation.
   Williams MD, Fei M, Schadde E, Hollinger EF, et al · · 2022 · cited 8× · PMID 35415217 · DOI 10.1097/txd.0000000000001321