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

Completed

Conditions studied: Transplant; Complication, Rejection

In brief

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 facts

Study ID

NCT04855422

Run by

Montefiore Medical Center

People needed

41

Starts

2021-07-14

Expected to finish

2026-06-22

Last updated by the study team

2026-07-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• SPK transplant recipients between 1 month and 3 years after transplantation

You may not qualify if…

• Previous history of solid organ transplantation
• Pregnancy

Where it is running

• Montefiore Medical Center — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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