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NCT04057742 · ClinicalTrials.gov registry record
AlloSure for the Monitoring of Antibody Mediated Processes After Kidney Transplantation
A clinical trial of Kidney Transplant Failure and Rejection, sponsored by University of Wisconsin, Madison.
- Completed
- Registry status
- 52
- Enrollment target
- 1
- Study location
NCT04057742: Completed study of Kidney Transplant Failure and Rejection, sponsored by University of Wisconsin, Madison.
NCT04057742 is a study of Kidney Transplant Failure and Rejection that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 52 participants, above the 15-participant average among 3 other Kidney Transplant Failure and Rejection trials with a reported enrollment target (247% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04057742, a study of Kidney Transplant Failure and Rejection, has completed, sponsored by University of Wisconsin, Madison.
- COMPLETED
- Registry status
- 52 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a prospective cohort observational study to assess the role of AlloSure Donor Derived Cell Free DNA (ddcfDNA) assay in the monitoring of three high-risk groups of kidney transplant patients for antibody mediated processes. * Group A. Thirty participants with a positive Virtual Cross-Match (VXM) at the time of transplant will be monitored for 12 months * Group B. Similarly, 24 participants with dnDSA will undergo a SOC biopsy within approximately three months to determine the incidence of Active Antibody Mediated Rejection (AMR) * Group C. 15 additional participants with the diagnosis of Chronic Active Antibody Mediated Rejection (cAMR) will undergo standard of care therapy and be monitored for treatment response with a follow-up biopsy at three months
Primary Outcome
To determine whether AlloSure, immune cell phenotypes, and inflammatory cytokines predict the incidence of AMR, the outcome measure will be incidence of biopsy confirmed AMR. For participants with a positive virtual crossmatch (group A), protocol biopsies are performed at 3 and 12 months posttransplant. For participants with De novo donor specific antibodies (dnDSA) (group B), protocol biopsies are performed within 3 months.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST AlloSure ddcfDNA assay
- DIAGNOSTIC_TEST AlloMap assay
- DIAGNOSTIC_TEST Inflammatory Cytokines
- DIAGNOSTIC_TEST Immune Cell Phenotypes
Study Locations (1)
Wisconsin
- University of Wisconsin - Madison - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2019-10-07 |
| Est. Completion | 2024-04-07 |
What the finished NCT04057742 record still lists
NCT04057742 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 52 participants, a relatively small participant target, above the 15-participant average among 3 other Kidney Transplant Failure and Rejection trials with a reported enrollment target (247% higher).
The record links to 1 condition, with Kidney Transplant Failure and Rejection appearing as the primary indexed condition, and to 4 interventions - of which AlloSure ddcfDNA assay is the first listed.
NCT04057742 reports a single indexed study location in Wisconsin.
Frequently Asked Questions
What is clinical trial NCT04057742 about?
NCT04057742 is a clinical study titled "AlloSure for the Monitoring of Antibody Mediated Processes After Kidney Transplantation". This is a prospective cohort observational study to assess the role of AlloSure Donor Derived Cell Free DNA (ddcfDNA) assay in the monitoring of three high-risk groups of kidney transplant patients for antibody mediated processes. * Group A. Thirty participants with a positive Virtual Cross-Match (...
What is the current status of trial NCT04057742?
This trial is currently completed. The enrollment target is 52 participants. The study started on 2019-10-07. Estimated completion is 2024-04-07.
What conditions does trial NCT04057742 study?
This clinical trial studies the following conditions: Kidney Transplant Failure and Rejection.
What interventions are being tested in trial NCT04057742?
The interventions under investigation include: AlloSure ddcfDNA assay (DIAGNOSTIC_TEST), AlloMap assay (DIAGNOSTIC_TEST), Inflammatory Cytokines (DIAGNOSTIC_TEST), Immune Cell Phenotypes (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04057742?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04057742 being conducted?
This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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