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

NCT04130685 | Completed

• 1 other identifier: 19073007
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreas Transplant Rejection; Kidney Transplant Rejection

Outcome Measures

Primary Outcomes (1)

• To determine median AlloSure level in SPK recipients with stable allograft function

  Percentage of dd-cfDNA (AlloSure) level in blood samples of recipients of kidney and pancreas transplant.

  Median allosure level collected from two weeks post transplant up until 36 months post transplant.

Secondary Outcomes (2)

• The Allosure levels will be measured in the setting of rejection.

  Throughout study completion, which is three years from date of transplant.

• To determine the Allosure level post transplant

  Throughout study completion, which is three years from date of transplant.

Interventions

Allosure Test DIAGNOSTIC_TEST

Venous Blood Draw

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Recipients of Simultaneous Pancreas and Kidney (SPK) transplant since 2012 and above the age of 18 will be enrolled.

You may qualify if:

• Participant is willing and able to give informed consent for participation in the study.
• Male or Female, aged 18 years or above.
• New SPK transplant recipients
• SPK recipients from September 2012 with functioning kidney and pancreas, not on dialysis and/or insulin

You may not qualify if:

• The participant may not enter the study if ANY of the following apply:
• Unwilling to participate in research study
• Recipients of other solid organ transplants apart from the SPK
• Recipients of pancreas and kidney allografts from separate donors
• Recipients with SLE
• Patients who have received a bone marrow transplant
• Recipients of a transplant form a monozygotic twin
• Patients who are pregnant
• Patients below the age of 18 years
• SPK recipient on insulin at enrolment
• SPK recipient on dialysis

Sponsors & Collaborators

• Rush University Medical Center: lead
• CareDx: collaborator

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Links

• Cell-Free DNA and Active Rejection in Kidney Allografts.

Study Officials

• Oyedolamu Olaitan, MBBS

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2019
• First Posted: October 17, 2019
• Study Start: January 15, 2020
• Primary Completion: May 31, 2021
• Study Completion: December 1, 2022
• Last Updated: December 2, 2022

Record last verified: 2022-12

Locations

US (1)