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Completed
NCT04855422
Assessing Benchmarks For Allosure And Allomap Testing in Simultaneous Kidney & Pancreas Transplant Recipients.
Conditions: Transplant; Complication, Rejection
Sex: All
Ages: 18 Years – N/A
Enrollment: 41
Sponsor: Montefiore Medical Center
Location: Montefiore Medical Center The Bronx New York
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
Eligibility Criteria
Inclusion Criteria:
* Participant is willing and able to give informed consent for participation in the study
* Male or Female, aged 18 years or above
* SPK transplant recipients between 1 month and 3 years after transplantation
Exclusion Criteria:
* Previous history of solid organ transplantation
* Pregnancy
Source: ClinicalTrials.gov (NCT04855422). StuddyBuddy aggregates publicly available trial information.