Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jul 12, 2022
Open Peer Review Period: Jul 12, 2022 - Jul 21, 2022
Date Accepted: Sep 30, 2022
(closed for review but you can still tweet)
CLinical utility of the omnigrAf® biomarkeR panel In The care of kidneY transplant recipients: CLARITY Trial Study Protocol
ABSTRACT
Background:
Death with a functioning allograft has become the leading category of graft loss in kidney transplant recipients at all time points. Previous analyses have demonstrated that causes of death in kidney transplant recipients are predominated by comorbidities with strong associations with immunosuppressant medications. Adverse drug events (ADEs) have been strongly associated with nonadherence, healthcare utilization, and graft loss; clinicians face a difficult decision on whether making immunosuppressant adjustments in the face of ADEs will provide improved symptomology or simply increase risk of acute rejection. Clinicians also face a treatment quandary in the 50% of kidney transplant recipients with stage 3 or worse chronic kidney disease at 1-year post-transplant, as progressive decline in renal function has been strongly associated with inferior allograft survival.
Objective:
The primary objective of the CLARITY Trial 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 (MRB) monitoring. A secondary objective is to identify the impact of OmniGrafTM use, in conjunction with patient-reported MRB, as part of clinical care on patient self-efficacy and quality of life (QoL).
Methods:
The CLARITY Trial is a 3-year, prospective, multisite, observational study with a matched control group.
Results:
The primary outcome measure of the study will be the comparison of the slope change in estimated glomerular filtration rate (eGFR) from baseline to the end of follow-up between study participants and a matched control group. Secondary outcome measures include changes over time in Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy for Managing Chronic Conditions – Managing Medications and Treatment-Short Form 4a, the PROMIS-29 Profile v2.1, and PROMIS Depression Scale in the study group, as well as a comparison of hospitalizations and causes, rejections, and graft and patient survival compared between subjects and a matched cohort.
Conclusions:
With this report we describe the study design, methods, and outcome measures that will be utilized in the ongoing CLARITY clinical trial. Clinical Trial: pending
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