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Acceptability and Feasibility of TruGraf® Testing as Part of the Standard of Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04267016
Recruitment Status : Not yet recruiting
First Posted : February 12, 2020
Last Update Posted : February 12, 2020
Sponsor:
Collaborator:
Duke University
Information provided by (Responsible Party):
Transplant Genomics, Inc.

Brief Summary:
This is an observational study in renal transplant recipients to evaluate the acceptability, feasibility, and clinical utility of TruGraf® testing in conjunction with standard clinical assessment. TruGraf is the first and only non-invasive test approved by Medicare to rule out silent rejection in stable kidney transplant recipients.

Condition or disease Intervention/treatment
Kidney Transplant Rejection Diagnostic Test: TruGraf Testing - Peripheral blood gene expression profiling

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Clinical Pilot Study to Test the Acceptability and Feasibility of TruGraf® Testing as Part of the Standard of Care
Estimated Study Start Date : February 2020
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Group/Cohort Intervention/treatment
All Subjects Enrolled
Renal transplant recipients who are undergoing routine management
Diagnostic Test: TruGraf Testing - Peripheral blood gene expression profiling
5 mL collection PAXgene blood sample
Other Name: Standard of care




Primary Outcome Measures :
  1. Clinical Utility of TruGraf Results [ Time Frame: through study completion, an average of 6 months ]
    Percent of total number of TruGraf results that the PI identified as having clinical utility

  2. Correlation of TruGraf Results [ Time Frame: through study completion, an average of 6 months ]
    Percent of total number of TruGraf results that the PI identified as being correlated to other clinical results obtained through the standard of care.

  3. Feasibility of TruGraf Testing [ Time Frame: through study completion, an average of 6 months ]
    Percent of total number of eligible subjects for whom the PI was able to complete the entire TruGraf testing workflow



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
All eligible renal transplant recipients who meet the inclusion/exclusion criteria will be part of this study.
Criteria

Inclusion Criteria:

  • Recipient of a primary or subsequent deceased-donor or living donor kidney transplantation.
  • Stable serum creatinine (current serum creatinine <2.3 mg/dl, <20% increase compared to the average of the previous 3 serum creatinine levels)
  • Kidney transplant patients who >90 days (+/- 2 weeks) post-transplant will be included in this study

Exclusion Criteria:

  • Need for combined organ transplantation with an extra-renal organ and/or islet cell transplant.
  • Recipients of previous non-renal solid organ and/or islet cell transplantation.
  • Infection with HIV.
  • Infection with BK nephropathy.
  • Patients that have nephrotic proteinuria (urine protein >3 gm/day).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04267016


Contacts
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Contact: Courtney Schieve 608-217-7978 courtney@transplantgenomics.com

Locations
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United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
Contact: Jennifer Thompson, RN, MSN    919-681-6898    jennifer.thompson@duke.edu   
Principal Investigator: Debra Sudan, MD         
Sponsors and Collaborators
Transplant Genomics, Inc.
Duke University
Investigators
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Study Director: John Holman, MD Transplant Genomics, Inc.
Publications:
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Responsible Party: Transplant Genomics, Inc.
ClinicalTrials.gov Identifier: NCT04267016    
Other Study ID Numbers: TGRP01-US001
First Posted: February 12, 2020    Key Record Dates
Last Update Posted: February 12, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No