Assessing AlloSure Dd-cfDNA Monitoring Insights of Renal Allografts With Longitudinal Surveillance (ADMIRAL)

September 30, 2020 updated by: CareDx
Prospective Observational Multicenter Cohort. External validation of donor derived cell free DNA in Renal Transplantation. Assessing performance of dd-cfDNA as a surveillance tool and its association with clinical outcomes. Outcomes include formation of de-novo DSA, eGFR decline, performance of AlloSure dd-cfDNA in Allograft rejection.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University Of Colorado Hospital
    • Florida
      • Tampa, Florida, United States, 33606
        • Tampa General Hosptial
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota Medical Center
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University
    • Texas
      • Houston, Texas, United States, 77030
        • Memorial Hermann Hosptial
    • Utah
      • Murray, Utah, United States, 84107
        • Intermountain Medical Center
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Renal transplant patients

Description

Inclusion Criteria:

  • Renal transplant patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Prospective observational cohort
Device: AlloSure
Patients will receive donor-derived cell-free DNA testing for surveillance and for-cause.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Validation of AlloSure in Allograft rejection
Time Frame: October 2020
October 2020

Secondary Outcome Measures

Outcome Measure
Time Frame
Performance of AS with De-Novo DSAs, Performance in subclinical and protocol biopsies vs clinically indicated for cause biopsies, Survival analysis considering AS surveillance
Time Frame: October 2020
October 2020

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CareDx

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2019

Primary Completion (ANTICIPATED)

October 1, 2020

Study Completion (ANTICIPATED)

October 1, 2020

Study Registration Dates

First Submitted

September 22, 2020

First Submitted That Met QC Criteria

September 22, 2020

First Posted (ACTUAL)

September 28, 2020

Study Record Updates

Last Update Posted (ACTUAL)

October 5, 2020

Last Update Submitted That Met QC Criteria

September 30, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • ADMIRAL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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