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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. CLINICALTRIAL pending

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 strongly associated with immunosuppressant medications. Adverse drug events (ADEs) have been strongly associated with nonadherence, health care utilization, and graft loss; clinicians face a difficult decision on whether making immunosuppressant adjustments in the face of ADEs will improve symptomology or simply increase the risk of acute rejection. Clinicians also face a treatment quandary in 50% of kidney transplant recipients with stage 3 or worse chronic kidney disease at 1 year post transplantation, as progressive decline in renal function has been strongly associated with inferior allograft survival. Objective The primary objective of the CLinical Utility of the omnigrAf biomarkeR Panel In The Care of kidneY Transplant Recipients (CLARITY) trial is to evaluate change in renal function over time in kidney transplant recipients who are undergoing OmniGraf monitoring in conjunction with monitoring of their medication-related symptom burden (MRSB). A secondary objective of this study is to identify the impact of OmniGraf use in conjunction with patient-reported MRSB as part of clinical care on patients’ self-efficacy and quality of life. Methods CLARITY is a 3-year prospective, multisite, observational study of 2000 participants with a matched control, measuring the impact of real-time patients’ MRSB and the OmniGraf biomarker panel on change in renal function over time. Secondary outcome measures include the Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy for Managing Chronic Conditions–Managing Medications and Treatment–Short Form 4a; the PROMIS-29 Profile (version 2.1); the PROMIS Depression Scale, hospitalizations—subcategorized for hospitalizations owing to infections; treated rejections, MRSB, and proportion of participants with overall graft survival at year 3 post transplantation; graft loss or death during the 3-year study follow-up period; and change in provider satisfaction. Results The primary outcome measure of the study will be a comparison of the slope change in estimated glomerular filtration rate from baseline to the end of follow-up between study participants and a matched control group. Secondary outcome measures include changes over time in PROMIS Self-Efficacy for Managing Chronic Conditions–Managing Medications and Treatment–Short Form 4a, the PROMIS-29 Profile (version 2.1), 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 participants and a matched cohort. The anticipated first enrollment in the study is October 2022 with data analysis and publication expected in October 2027. Conclusions Through this report, we describe the study design, methods, and outcome measures that will be utilized in the ongoing CLARITY trial. Trial Registration ClinicalTrials.gov NCT05482100; https://clinicaltrials.gov/ct2/show/NCT05482100 International Registered Report Identifier (IRRID) PRR1-10.2196/41020

BACKGROUND Medication errors, adverse drug events, and nonadherence are the predominant causes of graft loss in kidney transplant recipients and lead to increased healthcare utilization. Research has demonstrated that clinical pharmacists have the unique education and training to identify these events early and develop strategies to mitigate or prevent downstream sequelae. In addition, studies utilizing mHealth interventions have demonstrated success in improving the control of chronic conditions that lead to kidney transplant deterioration. OBJECTIVE The goal of the prospective, randomized TRANSAFE Rx study is to measure the clinical and economic effectiveness of a pharmacist-led, mHealth-based intervention, as compared to usual care, in kidney transplant recipients. METHODS TRANSAFE Rx is a 12-month, parallel, two-arm, 1:1 randomized controlled clinical trial involving 136 participants (68 in each arm) and measuring the clinical and economic effectiveness of a pharmacist-led intervention which utilizes an innovative mobile health application to improve medication safety and health outcomes, as compared to usual posttransplant care. RESULTS The primary outcome measure of this study will be the incidence and severity of MEs and ADRs, which will be identified, categorized, and compared between the intervention and control cohorts. The exploratory outcome measures of this study are to compare the incidence and severity of acute rejections, infections, graft function, graft loss, and death between research cohorts and measure the association between medication safety issues and these events. Additional data that will be gathered includes sociodemographics, health literacy, depression, and support. CONCLUSIONS With this report we describe the study design, methods, and outcome measures that will be utilized in the ongoing TRANSAFE Rx clinical trial. CLINICALTRIAL ClinicalTrials.gov NCT03247322: https://clinicaltrials.gov/ct2/show/NCT03247322 (Archived by WebCite at http://www.webcitation.org/6xcSUnuzW)