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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 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.

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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

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

FieldValue
Enrollment Target 52 participants
Start Date 2019-10-07
Est. Completion 2024-04-07

Sponsor

University of Wisconsin, Madison

1,039 total trials

What the Registry Record Tells You About NCT04057742

The ClinicalTrials.gov registry entry for NCT04057742 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 15-participant average among 3 other Kidney Transplant Failure and Rejection trials with a reported enrollment target (247% higher). The listed sponsor is University of Wisconsin, Madison, which has 1,039 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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