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Assessing Benchmarks For Allosure And Allomap Testing in Simultaneous Kidney & Pancreas Transplant Recipients.

NCT04855422 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 42

Last updated 2026-02-05

No results posted yet for this study

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

Conditions

  • Transplant; Complication, Rejection

Interventions

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

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.

Sponsors & Collaborators

  • CareDx

    collaborator INDUSTRY

  • Montefiore Medical Center

    lead OTHER

Principal Investigators

  • Enver Akalin, MD · Montefiore Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-14
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04855422 on ClinicalTrials.gov