Clinical trial NCT05482100: CLinical Utility of the omnigrAf® biomarkeR Panel In The Care of kidneY Transplant Recipients
Official title: CLinical Utility of the omnigrAf® biomarkeR Panel In The Care of kidneY Transplant Recipients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Kidney Transplant Rejection
Keywords: Biomarkers
Subclinical Rejection
Immunosuppression
Lead sponsor: Transplant Genomics, Inc.
Sponsor class: INDUSTRY
First posted: 2022-08-01
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study is an observational study in adult (age ≥ 18 years), kidney transplant patients who are at 3 months to 2 years from the time of transplant. Approximately 500 subjects will be enrolled.

Brief summary: This is a prospective, multi-site, observational study with a matched control group. The primary objective is to evaluate change in renal function over time in recipients of kidney transplants who are undergoing OmniGrafTM monitoring in conjunction with patient medication-related burden monitoring.

Detailed description: The survival benefits of solid organ transplants in the United States are well documented. Improvements in immunosuppression, better anti-microbial agents, and other aspects of ancillary care have resulted in significant improvements in short- term outcomes; however, there has been little improvement in long-term graft loss. A more recent analysis found that 65% of hospital readmissions in kidney transplant recipients had adverse drug events (ADE) considered contributory, and ADE-associated readmissions had a significantly higher hazard or graft loss and death compared to patients with readmissions not associated with an ADE. Even with knowledge of ADEs, clinicians may be reluctant to adjust immunosuppressive medications due to concerns of rejection risk during the period of medication adjustment. The OmniGrafTM biomarker panel (Transplant Genomics, Inc, Framingham, MA) includes the TruGraf® peripheral blood expression profile and the TRAC donor-derived cell-free DNA(dd-cfDNA) test, which have demonstrated a strong ability to identify immune quiescence in stable patients post kidney transplant, with a NPV of 94% when both tests are negative and a PPV of 89% for subclinical rejection when both tests are positive. Because of the strong "rule out" capabilities of OmniGrafTM, it would be an ideal complement to real-time ADE knowledge to help guide clinicians' decisions to adjust, or not adjust, the immunosuppressive regimen, and help provide a dialogue between patients and clinicians on the risk-benefit of medication adjustments. The aim of this study is to evaluate change in renal function over time in recipients of kidney transplants who are undergoing OmniGrafTM monitoring in conjunction with patient medication-related burden monitoring.

Eligibility 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;
* Between 3 months and 2 years post-transplant;
* Selected by provider to undergo OmniGraf™ testing as part of usual post-transplant care

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 Human Immunodeficiency Virus (HIV);
* Known to have active BK nephropathy;
* Known to have nephrotic proteinuria (per principal investigator); or
* Participation in other biomarker studies

Primary outcomes:
measure: GFR changes between study group and matched control group
timeFrame: 3 years
Secondary outcomes:
measure: PROMISE and Self efficacy results from baseline to study completion
timeFrame: 3 years
measure: PROMISE results from baseline to study completion
timeFrame: 3 years
measure: PROMIS Depression scale from baseline to study completion
timeFrame: 3 years
measure: Comparison of Hospitlizations due to infections in the matched control and study group
timeFrame: 3 years
measure: Comparison of rejection of matched control and study group
timeFrame: 3 years
measure: MRSB
timeFrame: 3 years
measure: Graft survival at 3 years comparison of matched control vs. study group
timeFrame: 3 years
measure: Graft survival at 1-2 years comparison of matched control vs. study group
timeFrame: 2 years
measure: Graft loss during study period
timeFrame: 3 years
measure: Graft survival during study period
timeFrame: 3 years
measure: Death-censored graft loss
timeFrame: 3 years
measure: Patient death during study period
timeFrame: 3 years
measure: Provider changes during study period
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
affiliation: Transplant Genomics
name: Patty West-Thielke, PharmD
role: STUDY_DIRECTOR
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