Non Invasive Blood Test To Diagnose Acute Rejection After Kidney Transplantation (DART)

December 13, 2018 updated by: CareDx

Circulating Donor-Derived Cell-free DNA in Blood for Diagnosing Acute Rejection in Kidney Transplant Recipients

This is a prospective, multicenter, observational study of kidney transplant subjects where blood specimens, intended for dd-cfDNA and other future research purposes, will be drawn after transplant

Study Overview

Status

Unknown

Conditions

Detailed Description

This is a prospective, multicenter, observational study of kidney transplant subjects where blood specimens, intended for dd-cfDNA and other future research purposes, will be drawn after transplant periodically and also after the treatment of acute rejection up to 8 weeks post treatment. The blood samples and all relevant clinical data will be provided to CareDx scientists for laboratory assay of dd-cfDNA levels and correlation of dd-cfDNA levels with the clinical features of the subjects.

The primary objective of the study is to correlate circulating dd-cfDNA to clinical and sub-clinical acute rejection in renal allograft recipients. The secondary objective of the study is to correlate circulating dd-cfDNA to renal function, both serum creatinine and estimated glomerular filtration rate [eGFR]).

Study Type

Observational

Enrollment (Actual)

401

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
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama, Birmingham
    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
      • Los Angeles, California, United States, 90024
        • University of California Los Angeles
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland
    • Minnesota
      • Minneapolis, Minnesota, United States, 55414
        • University of Minnesota
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University
    • New York
      • New York, New York, United States, 10032
        • Columbia University
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvannia
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Fort Worth, Texas, United States, 76104
        • Baylor Research Institute
      • Temple, Texas, United States, 76502
        • Baylor Scott and White

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult de novo living and deceased donor kidney transplant recipients will be eligible to participate in this study.

Description

Inclusion Criteria

  1. Adult recipients (Age > 18 years )
  2. Both genders and all racial and ethnic groups
  3. Kidney transplant alone
  4. Both living and deceased donor transplants
  5. Primary and re-transplants. A total of 30 re-transplant recipients across all study sites will be eligible for enrollment. CareDx will notify all centers when this subset of enrollment has been met. Thereafter, all enrolled patients should be primary transplant recipients.
  6. Ability to come for follow-up and undergo biopsy (Performed in accordance to SOC)
  7. Ability to give written informed consent prior to study enrollment

Patients can be enrolled at any time; before or after transplantation and/or at time of outpatient or inpatient visits for workup of medical problems; e.g. at the time of a renal biopsy (regardless of elapsed time since post transplant) as specified in this study protocol.

Exclusion Criteria

  1. Pediatric recipients (Age < 18 years)
  2. Pregnant women
  3. Patients undergoing multi-organ transplants (e.g. kidney with pancreas or liver)
  4. Patients receiving donor organ from an identical twin

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Kidney Transplant Recipients
Adult living and deceased donor kidney transplant recipients will be eligible to participate in this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical T cell as well as antibody mediated acute rejection
Time Frame: Occurring within 12 months post transplant
Occurring within 12 months post transplant
Sub-clinical T cell as well as antibody mediated acute rejection
Time Frame: Occurring within 12 months post transplant
Occurring within 12 months post transplant
Composite of clinical and sub-clinical T cell as well as antibody mediated acute rejection
Time Frame: Occurring within 12 months post transplant
Occurring within 12 months post transplant

Secondary Outcome Measures

Outcome Measure
Time Frame
eGFR (estimated Glomerular Filtration Rate [mL/min]): will be derived from serum creatinine level, corrected for variables, using the CKD-RPI (Chronic Kidney Disease Epidemiology Collaboration) equation
Time Frame: 24 months
24 months
Renal allograft injury from BKV nephritis, CNI toxicity, acute pyeloenephrtiis and recurrent disease confirmed by renal histology
Time Frame: 24 months
24 months

Collaborators and Investigators

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

Sponsor

CareDx

Investigators

  • Study Director: James Yee, MD, CareDx

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

April 1, 2015

Primary Completion (Actual)

August 30, 2018

Study Completion (Anticipated)

January 31, 2019

Study Registration Dates

First Submitted

April 20, 2015

First Submitted That Met QC Criteria

April 21, 2015

First Posted (Estimate)

April 22, 2015

Study Record Updates

Last Update Posted (Actual)

December 17, 2018

Last Update Submitted That Met QC Criteria

December 13, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • SN-C-00006

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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