CLinical Utility of the omnigrAf® biomarkeR Panel In The Care of kidneY Transplant Recipients (CLARITY)

July 27, 2022 updated by: Transplant Genomics, Inc.
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients monitored with OmniGraf Testing
Subjects will have OmniGraf™ testing at study enrollment and thereafter every 3 months or at the same time as standard routine labs (minimum two per year). In addition, subjects will have OmniGraf™ testing at any time there is a workup for clinical events and referral to advanced care (transplant center, biopsy, etc)
Diagnostic test: Patients monitored with OmniGraf testing
This is an observational study there are no protocol mandated interventions. OmniGraf results will be utilized in conjunction with standard of care assessments to determine patient management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
GFR changes between study group and matched control group
Time Frame: 3 years
Comparison of the slope change in estimated glomerular filtration rate (eGFR), calculated using the MDRD 4-variable equation and CKD-EPI, from baseline to the end of follow-up between study participants and a matched control group.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PROMISE and Self efficacy results from baseline to study completion
Time Frame: 3 years

Comparison of the Patient-Reported Outcomes Measurement Information System(PROMIS) Self-Efficacy for Managing Chronic Conditions - Managing Medications and Treatment-Short Form 4a (Self-Efficacy) at the end of follow-up to baseline PROMIS tools were developed to be disease non-specific measures of health-related domains. Each domain in composed of an item bank specific to a trait being measured. Item banks are calibrated on a common scale to facilitate comparability across varying populations. Depression is measured by various questions with answers ranging from never to always.

Raw scores are transformed to standardized T-score metrics, with a mean of 50 and standard deviation of 10
3 years
PROMISE results from baseline to study completion
Time Frame: 3 years

Comparison of the PROMIS-29 Profile v2.1 at the end of follow-up to baseline PROMIS tools were developed to be disease non-specific measures of health-related domains. Each domain in composed of an item bank specific to a trait being measured. Item banks are calibrated on a common scale to facilitate comparability across varying populations. Depression is measured by various questions with answers ranging from never to always.

Raw scores are transformed to standardized T-score metrics, with a mean of 50 and standard deviation of 10
3 years
PROMIS Depression scale from baseline to study completion
Time Frame: 3 years
Comparison of the PROMIS Depression scale at the end of follow-up to baseline. PROMIS tools were developed to be disease non-specific measures of health-related domains such as self-efficacy for symptom and medication management, depression, anxiety, fatigue, pain interference, sleep disturbance, and physical functioning. Each domain in composed of an item bank specific to a trait being measured. Item banks are calibrated on a common scale to facilitate comparability across varying populations. Depression is measured by various questions with answers ranging from never to always.
3 years
Comparison of Hospitlizations due to infections in the matched control and study group
Time Frame: 3 years
Rate of hospitalizations, subcategorized for hospitalizations due to infections, compared between study participants and a matched control group
3 years
Comparison of rejection of matched control and study group
Time Frame: 3 years
Incidence of treated rejections, compared between study participants and a matched control group
3 years
MRSB
Time Frame: 3 years
Medication-Related Symptom Burden (MRSB), as defined as the change in number and severity of adverse effects
3 years
Graft survival at 3 years comparison of matched control vs. study group
Time Frame: 3 years
Proportion of subjects with overall graft survival (including death with a functioning allograft) at year 3 post-transplant, compared between study participants and a matched control group
3 years
Graft survival at 1-2 years comparison of matched control vs. study group
Time Frame: 2 years
Proportion of subjects with overall graft survival at year 1 and year 2 post-enrollment, compared between study participants and a matched control group
2 years
Graft loss during study period
Time Frame: 3 years
Number of participants with graft loss, defined as permanent return to dialysis, retransplantation or patient death at any time during the 3-year primary follow-up study period;
3 years
Graft survival during study period
Time Frame: 3 years
Graft survival calculated from the date of kidney transplantation until date of graft loss
3 years
Death-censored graft loss
Time Frame: 3 years
Number of participants with death-censored graft loss, defined as permanent return to dialysis or retransplantation at any time during the 3-year primary follow-up study period. Patients who die with a functioning graft will be right censored
3 years
Patient death during study period
Time Frame: 3 years
Number of participants with patient death from any cause at any time during the 3-year primary follow-up study period
3 years
Provider changes during study period
Time Frame: 3 years
Rate of change in provider satisfaction from baseline to the end of follow-up using questionnaire
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Transplant Genomics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 1, 2022

Primary Completion (ANTICIPATED)

June 1, 2026

Study Completion (ANTICIPATED)

June 1, 2026

Study Registration Dates

First Submitted

July 18, 2022

First Submitted That Met QC Criteria

July 27, 2022

First Posted (ACTUAL)

August 1, 2022

Study Record Updates

Last Update Posted (ACTUAL)

August 1, 2022

Last Update Submitted That Met QC Criteria

July 27, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TGRP11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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