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Assessing Benchmarks For Allosure And Allomap Testing in Simultaneous Kidney & Pancreas Transplant Recipients.
Sponsor: Montefiore Medical Center
Summary
This is a non-randomized, non-interventional, prospective pilot cohort study to monitor SPK patients post-transplant to determine if non-invasive measures using dd-cfDNA (Allosure) and AlloMap can assess an array of immune panels to predict and confirm the development of allograft injury and rejection in either organ. Aims of the study 1. To develop and validate AlloSure and AlloMap in SPK transplant recipients with stable allograft function and in diagnosis of acute TCMR and ABMR in either organ 2. To assess the ability of AlloSure and AlloMap to determine early discordant rejection in SPK recipients 3. To investigate AlloSure and AlloMap in SPK transplant recipients with diagnosis of BKV viremia
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
42
Start Date
2021-07-14
Completion Date
2026-06
Last Updated
2026-02-05
Healthy Volunteers
Not specified
Conditions
Interventions
Allosure
AlloSure Analysis For the AlloSure test, 10-20 mL of blood will be obtained in Streck Cell-Free DNA blood collection tubes (BCT) and shipped to CareDx, Inc. (Brisbane, CA) at ambient temperature in insulated packaging to minimize temperature fluctuation. The AlloSure test will be performed at the CareDx CLIA/CAP-accredited clinical laboratory. Samples will be tested, and results provided within 3 days of blood draw.
AlloMap
AlloMap Kidney is intended to aid in the identification of SPK transplant recipients who have a low probability of rejection at the time in testing in conjunction with standard clinical assessment. For the AlloMap-Kidney test, approximately two tubes of blood will be obtained in PAXgene Blood RNA tubes and shipped to CareDx, Inc. (Brisbane, CA), where it will be tested.
Locations (1)
Montefiore Medical Center
The Bronx, New York, United States