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TruGraf® Long-term Clinical Outcomes Study

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: NCT04491552
Recruitment Status : Recruiting
First Posted : July 29, 2020
Last Update Posted : November 14, 2022
Sponsor:
Information provided by (Responsible Party):
Transplant Genomics, Inc.

Study Description
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Brief Summary:
This is a prospective, multi-center, observational study. Subjects will have OmniGraf™ (TruGraf® and TRAC™) testing at study enrollment and thereafter every 3 months. In addition subjects will have OmniGraf™ (TruGraf® and TRAC™) testing at any time there is a clinical suspicion of acute rejection. Data collection for the primary objective extends over a 2-year period.

Condition or disease Intervention/treatment
Kidney Transplant Rejection Diagnostic Test: Patients monitored with TruGraf and TRAC testing

Detailed Description:

Several studies have validated TruGraf® in stable renal transplant patients to rule out subclinical acute rejection. These studies generally evaluated the diagnostic value of TruGraf® at single timepoints. Thus the value of serial monitoring and changes over time has not been previously investigated. In addition, no study has assessed TruGraf® and TRAC™in a serial and longitudinal fashion.

Therefore the aim of this study is to evaluate the impact of serial monitoring renal transplant patients with both TruGraf® and TRAC™ on long term outcomes.

Study Design
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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: TruGraf® Long-term Clinical Outcomes Study
Actual Study Start Date : September 9, 2020
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : November 2023
Groups and Cohorts
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Group/Cohort Intervention/treatment
Patients monitored with TruGraf and TRAC testing
Subjects will have TruGraf and TRAC testing at study enrollment (Baseline) and thereafter every 3 months. In addition subjects will have TRAC testing at any time there is a suspicion of acute rejection.
 Diagnostic Test: Patients monitored with TruGraf and TRAC testing
This is an observational study there are no protocol mandated interventions. TruGraf and TRAC results will be utilized in conjunction with standard of care assessments to determine patient management.


Outcome Measures
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Primary Outcome Measures :
  1. occurrence of either biopsy proven acute rejection (BPAR) on a for cause biopsy or graft loss, or a decrease from baseline in eGFR > 10 mL/min. [ Time Frame: Baseline to month 24 ]

Secondary Outcome Measures :
  1. First occurrence of biopsy proven acute rejection (on a for cause biopsy) [ Time Frame: Baseline to month 24 ]
  2. First occurrence of clinically treated acute rejection [ Time Frame: Baseline to month 24 ]
  3. Proteinuria [ Time Frame: Baseline to month 24 ]
    defined by a spot urine protein-creatinine ratio > 0.5

  4. TruGraf results [ Time Frame: Baseline to month 24 ]
    The proportion of TruGraf not-TX results

  5. TRAC results [ Time Frame: Baseline to month 24 ]
    The proportion of TRAC results > 0.69

  6. Clinical Utility of TruGraf and TRAC in clinical decision making [ Time Frame: Baseline to month 24 ]
    Percent of total number of TruGraf results that the PI identified as having clinical utility

  7. Proportion of subjects who develop de novo donor-specific HLA antibodies class I and class II (dnDSA) [ Time Frame: Baseline to month 24 ]
    Proportion of subjects who develop de novo donor-specific HLA antibodies class I and class II (dnDSA)

  8. Proportion of subjects with graft loss [ Time Frame: Baseline to month 24 ]
    defined as permanent return to dialysis, retransplantation or patient death at any time during the 2-year primary follow-up study period

  9. Graft survival [ Time Frame: Baseline to month 24 ]
    calculated from the date of kidney transplantation until data of graft loss

  10. Proportion of subjects with death-censored graft loss [ Time Frame: Baseline to month 24 ]
    defined as permanent return to dialysis or retransplantation at any time during the 2-year primary follow-up study period. Patients who die with a functioning graft will be right censored

  11. Percent subject death period [ Time Frame: Baseline to month 24 ]
    Subject death from any cause at any time

  12. Subject survival [ Time Frame: Baseline to month 24 ]
    calculated from date of kidney transplantation until date of patient death

  13. Estimated GFR [ Time Frame: Baseline to month 24 ]
    calculated using the MDRD 4-variable equation


Biospecimen Retention:   Samples With DNA
whole blood

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This study is an observational study in adult (age ≥ 18 years), kidney transplant patients who are at least one year from the time of transplant. Approximately 2000 subjects will be enrolled.
Criteria

Inclusion Criteria:

  • Written informed consent and HIPAA authorization;
  • At least 18 years of age;
  • Recipient of a primary or subsequent deceased-donor or living-donor kidney transplant;
  • At least 3-months post-transplant;
  • Stable serum creatinine (per Principal Investigator);
  • Treated with any immunosuppressive regimen, and;
  • Selected by provider to undergo OmniGraf™ (TruGraf® and TRAC™) testing as part of post-transplant care; and

Exclusion Criteria:

  • Recipient of a combined organ transplant with an extra-renal organ and/or islet cell transplant;
  • Recipient of a previous non-renal solid organ and/or islet cell transplant;
  • Known to be pregnant;
  • Known to be infected with HIV;
  • Known to have Active BK nephropathy;
  • Known to have nephrotic proteinuria (Per Principal Investigator);
  • Participation in other biomarker studies testing clinical utility.
Contacts and Locations
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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): NCT04491552


Contacts
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Contact: Isioma Agboli, MD 510-767-8609 isiomaagboli@eurofins-tgi.com

Locations
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Sponsors and Collaborators
Transplant Genomics, Inc.
Investigators
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Principal Investigator: Patty W. Thielke, PharmD Transplant Genomics, Inc.
More Information
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Publications:
First MR, Pierry, D, McNultuy, M et al. Analytical and clinical validation of a molecular diagnostic signature in kidney transplant recipients. J Transplant. Technol. Res. 2017; 7(3).
US Renal Data System. 2016 USRDS annual data report: Epidemiology of kidney disease in the United States. Bethesda, MD: National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases; 2016.

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Responsible Party: Transplant Genomics, Inc.
ClinicalTrials.gov Identifier: NCT04491552    
Other Study ID Numbers: TGRP06
First Posted: July 29, 2020    Key Record Dates
Last Update Posted: November 14, 2022
Last Verified: November 2022
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: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Transplant Genomics, Inc.:
Biomarkers
Subclinical Rejection