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COMPLETED

AlloSure for the Monitoring of Antibody Mediated Processes After Kidney Transplantation

NCT04057742 · View on ClinicalTrials.gov ↗

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

943 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04057742

The ClinicalTrials.gov registry entry for NCT04057742 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Wisconsin, Madison, which has 943 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04057742 reports 1 study location spanning 1 distinct geographic area — top geographies include Wisconsin. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04057742?

This trial is sponsored by University of Wisconsin, Madison, which has 943 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial