TruGraf® Long-term Clinical Outcomes Study

Recruiting

• Conditions: Kidney Transplant Rejection

• Registration Number: NCT04491552
• Lead Sponsor: Transplant Genomics, Inc.

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.

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 Timeline

• Study First Submitted: 2020-07-23
• Study First Submitted QC: 2020-07-28
• Study First Posted: 2020-07-29
• Study Start: 2020-09-09
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-10
• Last Update Posted: 2022-11-14
• Primary Completion: 2023-09
• Study Completion: 2023-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	Baseline to month 24

Secondary Outcome Measures

Name	Time	Method
TruGraf results	Baseline to month 24	The proportion of TruGraf not-TX results
TRAC results	Baseline to month 24	The proportion of TRAC results \> 0.69
Proportion of subjects who develop de novo donor-specific HLA antibodies class I and class II (dnDSA)	Baseline to month 24	Proportion of subjects who develop de novo donor-specific HLA antibodies class I and class II (dnDSA)
First occurrence of biopsy proven acute rejection (on a for cause biopsy)	Baseline to month 24
First occurrence of clinically treated acute rejection	Baseline to month 24
Clinical Utility of TruGraf and TRAC in clinical decision making	Baseline to month 24	Percent of total number of TruGraf results that the PI identified as having clinical utility
Proportion of subjects with death-censored graft loss	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
Proportion of subjects with graft loss	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
Percent subject death period	Baseline to month 24	Subject death from any cause at any time
Subject survival	Baseline to month 24	calculated from date of kidney transplantation until date of patient death
Estimated GFR	Baseline to month 24	calculated using the MDRD 4-variable equation
Graft survival	Baseline to month 24	calculated from the date of kidney transplantation until data of graft loss
Proteinuria	Baseline to month 24	defined by a spot urine protein-creatinine ratio \> 0.5

Trial Locations

Locations (36)

Banner University Medical Center Tucson; 🇺🇸 Tucson, Arizona, United States

Fresno Nephrology Medical Group; 🇺🇸 Fresno, California, United States

Scripps Memorial Hospital La Jolla; 🇺🇸 La Jolla, California, United States

Keck Hospital of USC; 🇺🇸 Los Angeles, California, United States

House of Transplant and Cancer- Riverside Community Hospital; 🇺🇸 Riverside, California, United States

University of California Davis; 🇺🇸 Sacramento, California, United States

California Pacific Medical Center; 🇺🇸 San Francisco, California, United States

MedStar Georgetown University Hospital; 🇺🇸 Washington, District of Columbia, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

University of Illinois-Chicago Medical Center; 🇺🇸 Chicago, Illinois, United States

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