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To create a world without kidney diseases, the ASN Alliance for Kidney Health elevates care by educating and informing, driving breakthroughs and innovation, and advocating for policies that create transformative changes in kidney medicine throughout the world.

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Kidney Week

Abstract: INFO40

Clinical Utility of the OmniGraf Biomarker Panel in the Care of Kidney Transplant Recipients (CLARITY) Trial

Session Information

  • Informational Posters
    November 03, 2022 | Location: Exhibit Hall, Orange County Convention Center‚ West Building
    Abstract Time: 10:00 AM - 12:00 PM

Category: Transplantation

  • No subcategory defined

Authors

  • Fleming, James, Transplant Genomics, Inc, Framingham, Massachusetts, United States
  • Ally, Winston, Transplant Genomics, Inc, Framingham, Massachusetts, United States
  • Hickey, Janelle, Transplant Genomics, Inc, Framingham, Massachusetts, United States
  • Stach, Leslie, Transplant Genomics, Inc, Framingham, Massachusetts, United States
  • Kawano, Allison, Transplant Genomics, Inc, Framingham, Massachusetts, United States
  • Cober, Timothy, Transplant Genomics, Inc, Framingham, Massachusetts, United States
  • Szczepanik, Amanda, Transplant Genomics, Inc, Framingham, Massachusetts, United States
  • Watson, Alicia R., Transplant Genomics, Inc, Framingham, Massachusetts, United States
  • West-Thielke, Patricia, Transplant Genomics, Inc, Framingham, Massachusetts, United States
Description

Death With a Functioning Allograft is now responsible for more than half of graft losses. Previous analyses have demonstrated that causes of death are predominated by comorbidities associated with immunosuppressants. Further, ADEs have been tied to higher rates of nonadherence, death and graft loss. Physicians are faced with another clinical conundrum when half of kidney transplant recipients have CKD stage 3 or worse at one year post-transplant.

Objectives
The primary objective is to evaluate the change in renal function over time in recipients of kidney transplants who are undergoing OmniGrafTM monitoring in conjunction with patient medication-related burden monitoring (MRBM).

Methods
This is a currently enrolling, prospective, multi-site, observational study with a matched comparison cohort.

Patients
500 subjects will be enrolled. Patients will be eligible for inclusion if they are at ≧ 18 and between 3 months and 2 years post-transplant. They will be excluded if they received a non-renal organ or islet cell transplant, pregnant, have HIV, BK Nephropathy, nephrotic proteinuria, or participating in other biomarker clinical trials.

Endpoints
The primary endpoint will be the comparison of the slope change in eGFR from baseline to the end of follow-up between study participants and a matched control group.
Secondary endpoints include:
PROMIS Self-Efficacy for Managing Chronic Conditions – Managing Medications and Treatment-Short Form 4a (Self-Efficacy); PROMIS-29 Profile v2.1; PROMIS Depression scale; hospitalizations, subcategorized for hospitalizations due to infections; treated rejections; graft loss.

Funding

  • Transplant Genomics, Inc
Abstract: INFO40

Clinical Utility of the OmniGraf Biomarker Panel in the Care of Kidney Transplant Recipients (CLARITY) Trial

Session Information

  • Informational Posters
    November 04, 2022 | Location: Exhibit Hall, Orange County Convention Center‚ West Building
    Abstract Time: 10:00 AM - 12:00 PM

Category:

  • No subcategory defined

Authors

  • Fleming, James, Transplant Genomics, Inc, Framingham, Massachusetts, United States
  • Ally, Winston, Transplant Genomics, Inc, Framingham, Massachusetts, United States
  • Hickey, Janelle, Transplant Genomics, Inc, Framingham, Massachusetts, United States
  • Stach, Leslie, Transplant Genomics, Inc, Framingham, Massachusetts, United States
  • Kawano, Allison, Transplant Genomics, Inc, Framingham, Massachusetts, United States
  • Cober, Timothy, Transplant Genomics, Inc, Framingham, Massachusetts, United States
  • Szczepanik, Amanda, Transplant Genomics, Inc, Framingham, Massachusetts, United States
  • Watson, Alicia R., Transplant Genomics, Inc, Framingham, Massachusetts, United States
  • West-Thielke, Patricia, Transplant Genomics, Inc, Framingham, Massachusetts, United States
Description

Death With a Functioning Allograft is now responsible for more than half of graft losses. Previous analyses have demonstrated that causes of death are predominated by comorbidities associated with immunosuppressants. Further, ADEs have been tied to higher rates of nonadherence, death and graft loss. Physicians are faced with another clinical conundrum when half of kidney transplant recipients have CKD stage 3 or worse at one year post-transplant.

Objectives
The primary objective is to evaluate the change in renal function over time in recipients of kidney transplants who are undergoing OmniGrafTM monitoring in conjunction with patient medication-related burden monitoring (MRBM).

Methods
This is a currently enrolling, prospective, multi-site, observational study with a matched comparison cohort.

Patients
500 subjects will be enrolled. Patients will be eligible for inclusion if they are at ≧ 18 and between 3 months and 2 years post-transplant. They will be excluded if they received a non-renal organ or islet cell transplant, pregnant, have HIV, BK Nephropathy, nephrotic proteinuria, or participating in other biomarker clinical trials.

Endpoints
The primary endpoint will be the comparison of the slope change in eGFR from baseline to the end of follow-up between study participants and a matched control group.
Secondary endpoints include:
PROMIS Self-Efficacy for Managing Chronic Conditions – Managing Medications and Treatment-Short Form 4a (Self-Efficacy); PROMIS-29 Profile v2.1; PROMIS Depression scale; hospitalizations, subcategorized for hospitalizations due to infections; treated rejections; graft loss.

Abstract: INFO40

Clinical Utility of the OmniGraf Biomarker Panel in the Care of Kidney Transplant Recipients (CLARITY) Trial

Session Information

  • Informational Posters
    November 05, 2022 | Location: Exhibit Hall, Orange County Convention Center‚ West Building
    Abstract Time: 10:00 AM - 12:00 PM

Category:

  • No subcategory defined

Authors

  • Fleming, James, Transplant Genomics, Inc, Framingham, Massachusetts, United States
  • Ally, Winston, Transplant Genomics, Inc, Framingham, Massachusetts, United States
  • Hickey, Janelle, Transplant Genomics, Inc, Framingham, Massachusetts, United States
  • Stach, Leslie, Transplant Genomics, Inc, Framingham, Massachusetts, United States
  • Kawano, Allison, Transplant Genomics, Inc, Framingham, Massachusetts, United States
  • Cober, Timothy, Transplant Genomics, Inc, Framingham, Massachusetts, United States
  • Szczepanik, Amanda, Transplant Genomics, Inc, Framingham, Massachusetts, United States
  • Watson, Alicia R., Transplant Genomics, Inc, Framingham, Massachusetts, United States
  • West-Thielke, Patricia, Transplant Genomics, Inc, Framingham, Massachusetts, United States
Description

Death With a Functioning Allograft is now responsible for more than half of graft losses. Previous analyses have demonstrated that causes of death are predominated by comorbidities associated with immunosuppressants. Further, ADEs have been tied to higher rates of nonadherence, death and graft loss. Physicians are faced with another clinical conundrum when half of kidney transplant recipients have CKD stage 3 or worse at one year post-transplant.

Objectives
The primary objective is to evaluate the change in renal function over time in recipients of kidney transplants who are undergoing OmniGrafTM monitoring in conjunction with patient medication-related burden monitoring (MRBM).

Methods
This is a currently enrolling, prospective, multi-site, observational study with a matched comparison cohort.

Patients
500 subjects will be enrolled. Patients will be eligible for inclusion if they are at ≧ 18 and between 3 months and 2 years post-transplant. They will be excluded if they received a non-renal organ or islet cell transplant, pregnant, have HIV, BK Nephropathy, nephrotic proteinuria, or participating in other biomarker clinical trials.

Endpoints
The primary endpoint will be the comparison of the slope change in eGFR from baseline to the end of follow-up between study participants and a matched control group.
Secondary endpoints include:
PROMIS Self-Efficacy for Managing Chronic Conditions – Managing Medications and Treatment-Short Form 4a (Self-Efficacy); PROMIS-29 Profile v2.1; PROMIS Depression scale; hospitalizations, subcategorized for hospitalizations due to infections; treated rejections; graft loss.