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NCT04855422 · ClinicalTrials.gov registry record
Assessing Benchmarks For Allosure And Allomap Testing in Simultaneous Kidney & Pancreas Transplant Recipients.
A clinical trial of Transplant; Complication, Rejection, sponsored by Montefiore Medical Center.
- Active
- Registry status
- 42
- Enrollment target
- 1
- Study location
NCT04855422: Active study of Transplant; Complication, Rejection, sponsored by Montefiore Medical Center.
NCT04855422 is a study of Transplant; Complication, Rejection that is active but no longer recruiting, run by Montefiore Medical Center. The registered enrollment target is 42 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04855422, a study of Transplant; Complication, Rejection, is active but no longer recruiting, sponsored by Montefiore Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- 42 participants
- Enrollment target
- 1
- Study location
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
Primary Outcome
To establish a benchmark for SPK transplant recipients with stable allograft function an AlloSure test score will be determined in stable kidney and pancreas transplant recipients. Patients will have blood samples for testing drawn in Streck Cell-Free DNA BCT tubes at the time of enrollment and at 3, 6, 9, and 12 months after enrollment. Samples will be shipped to CareDx for analysis. AlloSure test scores will be reported as a test score percentage (%). Lower AlloSure test score percentages are
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Allosure
- DIAGNOSTIC_TEST AlloMap
Study Locations (1)
New York
- Montefiore Medical Center - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2021-07-14 |
| Est. Completion | 2026-06 |
What the registry record for NCT04855422 still lists
NCT04855422 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 42 participants, a relatively small participant target.
The record links to 1 condition, with Transplant; Complication, Rejection appearing as the primary indexed condition, and to 2 interventions - of which Allosure is the first listed.
NCT04855422 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT04855422 about?
NCT04855422 is a clinical study titled "Assessing Benchmarks For Allosure And Allomap Testing in Simultaneous Kidney & Pancreas Transplant Recipients.". 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 rejecti...
What is the current status of trial NCT04855422?
This trial is currently active not recruiting. The enrollment target is 42 participants. The study started on 2021-07-14. Estimated completion is 2026-06.
What conditions does trial NCT04855422 study?
This clinical trial studies the following conditions: Transplant; Complication, Rejection.
What interventions are being tested in trial NCT04855422?
The interventions under investigation include: Allosure (DIAGNOSTIC_TEST), AlloMap (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04855422?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04855422 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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