Active — Not RecruitingNot Applicable

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

United States42 participantsStarted 2021-07-14

Plain-language 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

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * Participant is willing and able to give informed consent for participation in the study * Male or Female, aged 18 years or above * SKP transplant recipients between 1 month and 3 years after transplantation Exclusion Criteria: * Previous history of solid organ transplantation * Pregnancy

What they're measuring

Establishing benchmarks for AlloSure and AlloMap in SPK transplant recipients with stable allograft function

Timeframe: 3, 6, 9, and 12 months after enrolment

Trial details

NCT IDNCT04855422

SponsorMontefiore Medical Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-06

View on ClinicalTrials.gov More Transplant; Complication, Rejection trials