Cytomegalovirus (CMV) remains a major contributor to morbidity after a kidney transplant. Although valganciclovir (VGC) prophylaxis is effective, its use is limited by leukopenia. Maribavir's (MAR) role in primary CMV prophylaxis is not established. We conducted a 12-month, single-center, open-label, randomized controlled trial including 70 adult recipients at high CMV risk randomized 1:1 to MAR 400 mg twice daily or VGC 900 mg daily. The incidence of clinically significant leukopenia during prophylaxis did not differ between arms (22.9% vs 5.7%, P = .084). For the secondary endpoint, VGC recipients spent a greater proportion of prophylaxis days below white blood cell thresholds (<3000/μL: 12.2% vs 2.4%, P < .001; <2000/μL: 3.0% vs 0.2%, P < .001; <1000/μL: 0.3% vs 0.1%, P = .027). As an exploratory endpoint, CMV outcomes appeared similar between arms, including any viremia (37% vs 43%, P = .626), polymerase chain reaction >1000 IU/mL (23% vs 31%, P = .420), and refractory infection (15% vs 17%, P = .743). No cases of CMV breakthrough, disease, or resistance occurred. Hospitalizations, rejection, graft loss, and mortality did not differ. In summary, as compared to VGC, MAR had a similar incidence of clinically significant leukopenia with reduced overall leukopenia burden. These findings should be confirmed in larger multicenter studies.

Obesity and end-stage kidney disease (ESKD) present deeply complex metabolic and immunological challenges. Metabolic and bariatric surgery (MBS) is increasingly recognized for its role in pretransplant weight optimization and metabolic regulation and has been shown to improve access to and allograft outcomes of kidney transplant (KTx). Whether MBS should be performed before or after KTx remains an important clinical decision, particularly when both approaches appear feasible and safe. Determining whether operative sequencing meaningfully influences patient outcomes may help guide individualized surgical planning in patients with obesity and end-stage kidney disease. This single-center cohort study (2012-2023) identified adults who underwent MBS and KTx using institutional databases. Patient characteristics, allograft function, immunosuppression, and perioperative outcomes were evaluated according to operative sequencing (MBS-first vs KTx-first). Twenty patients (n = 11 KTx-first, n = 9 MBS-first) were identified. At the time of transplant, BMI was lower in patients in the MBS-first cohort (31.9 kg/m2 vs 38.1, P = .044). Weight loss at 1-year post-MBS was similar between groups (KTx-first BMI change -7.6 kg/m2 vs MBS-first -8.9, P = .790). Metabolic and bariatric surgery 30-day perioperative events occurred in five (25%) patients: three emergency room visits, one readmission, two wound complications, and one peritoneal dialysis catheter infection. At a median of 4.6 years post-KTx, graft survival was 80% (n = 16), which was similar between KTx-first (81.8%) and MBS-first (77.8%). Within the limitations of this retrospective study, no significant differences in perioperative, weight loss, or graft outcomes were observed between sequencing strategies and may suggest that operative timing can be individualized based on patient-specific factors, transplant candidacy, metabolic disease severity, and multidisciplinary care considerations rather than a universally preferred sequence.

There has been a worldwide reduction in pancreas transplant volume over the last decade. Understanding factors, such as procurement extraction time (ET), that play a key role in organ recovery can increase confidence in organ acceptance and improve organ utilization. All patients who underwent deceased donor pancreas transplantation at a single US center between January 2019 and August 2024 were stratified by ET and retrospectively reviewed. A total of 137 transplants were included in the analysis with 72 patients in the ET ≤ 40 min group and 65 patients in the ET > 40 min group. We found no significant difference in all-cause pancreas graft loss between the ET ≤ 40 min and ET > 40 min group (6.9% vs 12%; p = 0.482), but there was a higher readmission rate at 90 days in the ET ≤ 40 min group (60% vs 39%; p = 0.015) regardless of adjustments in multivariate analysis. We demonstrate for the first time at a US center that while ET is not associated with all-cause graft loss, it may impact postoperative outcomes such as readmission rates and could have important implications for the future of pancreas utilization.

BACKGROUND:Individuals 65 years of age or older represent the fastest-growing segment of the US and end-stage renal disease (ESRD) populations. This analysis assessed trends in kidney transplant (KTX) access and outcomes in patients younger than 65 vs 65 years or older. STUDY DESIGN:We conducted a longitudinal cohort study using merged United Network of Organ Sharing, United States Renal Data System, and Vizient data. United Network of Organ Sharing included patients waitlisted and transplanted at the study institution through 2025. United States Renal Data System provided ESRD prevalence (2020 to 2022), and Vizient provided outcomes data (2022 to 2024). RESULTS:ESRD prevalence was nearly fourfold higher in individuals 65 years of age or older vs younger than 65 (6.0 vs 1.6 per 1,000). The proportion of individuals 65 years of age or older added to the institutional KTX waitlist rose from 2% in 1990 to 22% in 2025, whereas they represented 43% of patients with ESRD. KTX outcomes (2022 to 2024) included 974 patients (759 younger than 65 vs 215 65 years or older). Groups were similar for sex and race or ethnicity. Patients 65 years of age or older had lower BMI, shorter dialysis duration, longer waitlist time, higher diabetes prevalence, and more marginal donor organs. Perioperative outcomes and resource use were similar. Older patients had higher rates of delayed graft function and discharge to rehabilitation but similar length of stay, complications, readmissions, and costs. Graft survival was excellent and comparable between groups. Overall mortality was very good, slightly lower at 2 to 3 years in those 65 years of age or older. CONCLUSIONS:Patients 65 years of age or older represent the fastest-growing ESRD segment. Although KTX access has improved, older patients remain underrepresented on waitlists. Outcomes and costs for select older recipients are comparable to younger patients. Further research is needed to safely expand KTX access in this population.

The American Society of Transplantation commissioned a survey assessing transplant recipients' perceptions of unmet immunosuppressant needs. Topics included medication side effects, treatment burden, health-related quality of life, adherence, self-efficacy, costs, trust, and discrimination; 10 091 responses were included (9543 adults, 548 pediatric respondents) representing 232 transplant centers. Respondents were a mean of 6.6 years posttransplant and were well-represented across age, gender, race, ethnicity, organ, employment, insurance, and immunosuppression. Nearly all (92%) respondents reported at least 1 side effect (median of 3); most side effects occurred "often" or "always." The majority (54%) of side effects were rated as having a "moderate" or "great deal" of impact on daily life. Side effects with the greatest daily burden included skin cancer, pain/neuropathy, skin issues, kidney disease, memory/brain fog, diabetes, cancer, and hypertension. Fatigue, headache, insomnia, tremors, and mood/depression/anxiety were the most selected side effects. Health-related quality of life was rated as "fair" to "good." Trust in providers, self-efficacy, and medication adherence were rated highly, though 25% reported skipping doses due to side effects, and 40% skipped due to costs. The findings demonstrate that side effects are nearly universally experienced and have a major burden on daily life. Immunosuppression induces a heavy toll on transplant recipients; there is an urgent need for new treatments to address these unmet needs.

Donor-derived cell-free DNA (dd-cfDNA) is a biomarker that enables the early detection of immune-mediated graft injury. This study evaluated the clinical utility of dd-cfDNA in predicting the presence of biopsy-proven rejection (BPAR). We analyzed 1070 biopsies from 1743 kidney transplant recipients enrolled in the prospective, multicenter Kidney Allograft Outcomes AlloSure Registry. Biopsies were grouped into surveillance or for-cause groups and stratified by dd-cfDNA status: elevated, nonelevated, or not tested. Rejection yield was significantly higher when dd-cfDNA was elevated: 39% vs 7% in the surveillance group and 47% vs 12% in the for-cause group (P < .0001). Biopsies with elevated dd-cfDNA and rejection diagnoses more frequently demonstrated antibody-mediated rejection and mixed rejection, whereas biopsies performed with nonelevated dd-cfDNA most often showed no rejection, borderline, or T cell-mediated rejection 1A. The area under the receiving operating characteristic curve for BPAR detection was 0.789. These findings demonstrate that dd-cfDNA levels can improve the pretest probability of BPAR in both surveillance and for-cause settings. Therefore, dd-cfDNA can optimize biopsy utilization by identifying kidney transplant patients who are most likely to have histologic rejection.

Background and aim: Cytomegalovirus (CMV) remains a critical post-transplant opportunistic infection despite significant advancements in monitoring and therapy. The impact of African-American (AA) race on CMV risk and outcomes has been insufficiently studied. This study aimed to determine secular trends in the incidence of CMV D+/R− mismatching and evaluate their association with AA race and clinical outcomes. Methods: This single-center longitudinal cohort study involved adult kidney recipients transplanted between January 2012 and June 2021, with follow-up through June 2022. Univariate and multivariate statistics were performed to analyze the data. Results: Of 2392 kidney transplant recipients, 2,261 were included in the final analysis after applying exclusion criteria. The mean age was 52 years, 41% were female, and 57% were black. In addition, 19% were classified as CMV high-risk. Secular trend analysis revealed an increase in CMV D+/R− rates over time. AAs had 51% lower odds of being CMV D+/R− (p<0.001), which remained stable over the study period (p=0.80). In adjusted models, AAs had a 50% higher risk of developing CMV infection (Hazard ratio [HR] = 1.49, confidence interval [CI]: 1.1 – 2.0) and late CMV infection (HR = 1.5, CI: 1.03 – 2.3), with no significant change over time (p>0.20). AA race was also a risk factor for acute rejection and death-censored graft loss, with no notable changes observed over the study period. Conclusion: In kidney transplant recipients, the incidence of CMV D+/R− serostatus has increased over the past decade. AAs are 50% less likely to be CMV D+/R− but have higher normalized rates of other complications, which remained relatively stable over the study period. Future studies should explore the underlying mechanisms contributing to the higher rates of CMV infection in AAs, which could facilitate the development of targeted interventions. Factors such as immunosenescence and genetic polymorphisms warrant further exploration. Relevance for patients: CMV risk, outcomes, racial disparities in kidney transplant.

Background/Aims:Neurotoxicity is commonly seen in liver transplant (LT) patients receiving tacrolimus. We sought to determine the impact of LCP tacrolimus on neurologic toxicity in LT recipients. Methods:This single-center, semiblinded, parallel group randomized controlled trial compared neurotoxicity burden in LT patients receiving immediate-release (IR) tacrolimus versus LCP tacrolimus. Thirty LT recipients transplanted between January 2020 and February 2022 were enrolled between 15 and 364 days posttransplant and followed for 6 months postrandomization. The primary endpoint was change from baseline to 6 months in composite Patient Global Impression of Improvement (PGI-I) score. Select secondary endpoints included change in Fahn-Tolosa-Marin (FTM) Tremor Rating Scale, IMAB-Q10, SF-12, and Medical Symptom Validity Test (MSVT) scores. Results:No significant differences were seen in composite PGI scores, though all patients saw improvement in overall PGI scores (IR -5 [-13.5 to -0.25] vs. LCP -4 [-9.5 to -0.5], p = 0.78). Other tests examining neurotoxicities showed no difference between groups but an overall trend toward improvement in symptoms between baseline and end of study. One episode of moderate rejection (rejection activity index [RAI] score of 6) was reported in the LCP group, with no episodes in the IR group (p = 0.31). No graft loss or mortality occurred in either group. Conclusions:Our study showed LCP tacrolimus had similar rates of neurotoxicity in LT recipients compared to IR without increasing the risk of rejection, graft loss, or mortality; these results suggest LCP tacrolimus can be a safe alternative in LT recipients. Trial Registration:ClinicalTrials.gov identifier: NCT03823768.

African Americans (AAs) with end-stage kidney disease (ESKD) experience significant barriers to accessing living donor kidney transplantation (LDKT), largely due to individual and systemic factors, including a lack of trust in healthcare systems resulting from a legacy of and continued experiences with medical racism. This cross-sectional study analyzed survey data from 416 AA patients with ESKD undergoing transplant evaluation in 2019–2023 at two kidney transplant centers in the Southeast United States, examining whether trust (specifically trust in kidney doctors, hospitals, and healthcare) modifies the relationship between attitudes towards LDKT and behavioral intentions to discuss LDKT with family and friends. Multivariable analyses revealed significant interactions. The regression model including attitudes and trust in kidney doctors was statistically significant (R2 = 0.114, F(7, 368) = 6.779, p ≤ 0.001). It was found that attitudes toward LDKT (β = 0.297, p ≤ 0.001) and trust in kidney doctors (β = 0.132, p = 0.008) were significantly associated with behavioral intentions to discuss LDKT with a family member or friend. Trust in hospitals, trust in the healthcare system, nor the interactions between attitudes and trust variables were significantly associated with behavioral intentions. Our findings support positive relationships between attitudes, trust in one’s kidney doctor, and behavioral intentions to pursue LDKT, which have important implications for interventions that seek to improve access to LDKT among AA patients with ESKD.

The goal of this study was to determine the secular trends in the incidence of CMV sero-mismatch (D+/R −) and if these trends meaningfully impact clinical outcomes. This was a single-center longitudinal cohort study in adult kidney recipients transplanted between Jan 2012 and June 2021 with follow-up through June 2022. Baseline and follow-up data were collected. Univariate and multivariate statistics were used to analyze the data. 2,392 kidney transplants were performed during the study period; 132 patients did not meet inclusion criteria. The mean age was 52 years, 41

Background Cytomegalovirus (CMV) infection remains a significant problem in kidney transplantation despite advances in screening, monitoring, therapeutics, and management. Although universal prophylaxis with antiviral therapy has significantly reduced the risk of early CMV infection and disease, late-onset CMV is still common and can be difficult to clinically manage in high-risk patients. A recent systematic review showed that with antiviral prophylaxis, early CMV infection occurred in only 6% of kidney recipients, and late infection occurred in more than one in six patients. The two antiviral prophylaxis medications this study is comparing, valganciclovir (VGC) and maribavir, are highly effective at preventing CMV infection. In studies using valganciclovir, the reported occurrence of leukopenia is 20%-40%, and neutropenia is 10%-30%. In studies using maribavir, the reported occurrence of neutropenia was 4%-5% versus 15%-18% in valganciclovir patients. With appropriate dosing, maribavir appears to have similar efficacy to valganciclovir in treating current and preventing future CMV infection with a significantly reduced rate of neutropenia. Methods Maribavir IIR is a 12-month, single-center, open-label, randomized controlled trial enrolling 70 patients (35 in each arm) examining the difference in preventing CMV infection while specifically assessing the tolerability of the two antiviral prophylactic medications. The trial is currently in the follow-up phase, with the first patient enrolled in November 2023 and enrollment concluding in June 2024. Discussion The primary objective of this study is to assess the tolerability of maribavir versus valganciclovir (VGC) prophylaxis in adult kidney transplant recipients at high risk of CMV infection (D+/R- or thymo use if R+). This was done by assessing the incidence of leukopenia in the two arms, the occurrence of CMV infection despite prophylaxis, the impact of these medications on healthcare utilization and costs, and any outcome differences associated with race and sex. In this preliminary report, we describe the study design, methods, aims, and outcome measures that will be utilized in the ongoing Maribavir IIR clinical trial. Trial registration The trial is registered at ClinicalTrials.gov NCT06034925: https://www.clinicaltrials.gov/study/NCT06034925.

The aim of this study was to assess the impact of CYP3A5 genotype-based tacrolimus (tac) XR versus weight-based dosing among adult kidney transplant recipients. This was a retrospective longitudinal matched cohort analysis. From February 2021 to June 2023, tac XR was dosed using standard weight-based dosing. Starting in June 2023, genotype-based dosing was used; 148 patients were included (74 in each arm). Baseline characteristics were well balanced between the groups, except for age (control 46 ± 14 vs. 52 ± 14 years, p < 0.01); 32% were females, 36% were African American, 84% were living donors, 40% had DM, and 10% had DGF. At 90-days post-txp, the genotype guided cohort had an average of two fewer tacrolimus dose adjustments per patients (4 vs. 6, p < 0.0001), spent longer time in therapeutic range (59% vs. 47%, p = 0.004), and less time in concerning range (9% vs. 18%, p < 0.0001). Acute rejection, de novo donor specific antibodies, and eGFR was similar between the two cohorts. This matched cohort analysis assessing a genotype-based dosing algorithm demonstrated improved tac XR dosing efficiency. Patients on average, needed two fewer dose adjustments, spent longer time in therapeutic range and had significantly less time in concerning range.

Background Optimizing long-term graft survival remains a major focus in transplant. Elderly kidney transplant recipients are vulnerable to acute kidney injury (AKI) and graft loss. This study assessed the safety and efficacy of ACEI/ARB in elderly kidney transplant recipients and impact on graft outcomes. Methods Retrospective, longitudinal, cohort study of 500 patients age ≥60 years, who underwent kidney transplantation between 2005-2015. Demographic, transplant, and outcomes data were collected. Manual chart abstraction was conducted to determine medication use at discharge, one, three, and five years post-transplant. Univariate and multivariable Cox regression modeling were used to analyze outcomes. Results Mean age of subjects was 66 years (range 60-81). 59% were males and 50% were African-American. 49% had chronic kidney disease (CKD) due to diabetes mellitus (DM). A total of 38, 134, 167, and 112 elderly kidney transplant recipients were on ACEI/ARB at discharge, one, three, and five years post-transplant respectively. ACEI/ARB initiated within one year of transplant was associated with lower risk of graft loss (HR=0.62, CI 0.38-0.99, p=0.047). This was driven mainly by a lower risk of death (HR=0.41, CI 0.24-0.71, p=0.002). ACEI/ARB use was associated with lower risk of AKI after 1 year (HR 0.70, CI 0.52-0.95, p=0.02). ACEI/ARB was not associated with increased risk of acute rejection or hospitalization. Conclusion Initiation of ACEI/ARB within one year of transplant is associated with lower risk of AKI and graft loss, driven by lower risk of death in elderly kidney transplant recipients. Clinicians should maximize ACEI/ARB therapy early on after kidney transplant.

Objectives Peripheral arterial disease (PAD) can reduce wound healing rates by ≤30%. Current literature suggests wound outcomes are improved when management is driven by vascular providers. However, whether this benefit is derived solely from early vascular provider involvement remains unclear. Methods A retrospective analysis was performed of 80 limbs with chronic wounds and underlying PAD seen at our institution's wound center between July 2022 and July 2023. Arterial disease was defined by the following criteria: (1) prior PAD diagnosis, (2) ankle-brachial-index of <0.9 or toe pressure of <70 mm Hg, or (3) absent peripheral pulses. Patients were divided into early (<6 week) vascular provider exposure (EVE; n = 45) or late/no vascular exposure (LNVE; n = 35). Providers included vascular surgeons and affiliated advanced practitioners. The primary outcome studied was overall time to wound healing. Statistical analysis included χ2 tests, t test, Pearson correlation, Kaplan-Meier analysis, and Cox regression modeling (variables included in a multivariate model if univariate effect on healing was associated at P < .1). Results Baseline demographic profiles were similar between groups with exception of lower baseline albumin (P = .037), more heart failure (P = .013), and more prior peripheral endovascular interventions (P = .013) in the EVE group. Although the initial wound locations and sizes were similar, EVE wounds had significantly higher WIfI wound scores (1.9 ± 0.1 vs 1.6 ± 0.1; P = .039). Although more LNVE patients developed radiographic osteomyelitis (31.8% vs 55.6%; P = .033), fewer underwent operative debridement or amputation (100% vs 63.2%; P = .008). On univariate analysis, healing time tended to be shorter in EVE, but not significantly (P = .089). When controlled for comorbidities, however, healing rates were nearly two-fold higher in EVE (hazard ratio, 2.42; 95% confidence interval, 1.21-4.84). LNVE wounds also took significantly longer to reach checkpoints including time to >75% granulation (P = .05), 15% weekly size decrease (P = .044), and epithelialization (P = .026). LNVE patients required more wound center visits (P = .024) and procedures (P = .005) with a longer time to intervention (P = .041). All EVE patients obtained ankle-brachial indices, with 90.9% of them available at their first wound care visit (P < .001). Although a slightly greater proportion of patients underwent a major amputation in EVE (15.6% vs 11.4%; P = .595), this difference did not attain significance; additionally, 100% of EVE patients had documented discussion of nonsalvageable limbs before amputation. Conclusions Early exposure to vascular practitioners improves wound healing time, timeliness to intervention, and wound center and hospital resource use in patients with PAD. Further investigation into benefits of vascular involvement within community wound center models could significantly improve awareness and accessibility of arterial wound care in smaller/remote communities.

BACKGROUND:The goal was to determine trends in immunosuppression use and its impact on cytomegalovirus (CMV) outcomes over the past 10 years. METHODS:This was a single-center longitudinal cohort study of adult kidney recipients transplanted between Jan 2012 and June 2021. Baseline and follow-up data were gathered via chart abstraction and analyzed using univariate and multivariate analyses. RESULTS:Of 2392 kidney transplants conducted, 131 patients did not meet inclusion criteria. The mean age was 52 years, 41% were female, 57% were black, and 19% were CMV high-risk. The use of rabbit anti-thymocyte globulin (RATG) induction (odds ratio [OR] 1.6, 1.3-2.1), tacrolimus (FK) level >8 ng/mL (OR 1.1, 1.09-1.11), CMV D+/R- rates (OR 1.06, 1.02-1.10), white blood cell count <3000 (OR 1.22, 1.18-1.26) and valganciclovir prophylaxis (OR 1.7, 1.6-1.9) have significantly increased over the past 10 years. Rejection rates (OR 0.86, 0.82-0.91) and BK viremia >2000 (OR 0.91, 0.91-0.98) have decreased. RATG induction (adjusted hazard ratio [aHR] 1.35, 1.2-1.5), FK >8 ng/mL (aHR 3.5, 3.2-3.9), Belatacept conversion (aHR 2.5, 2.1-3.1), and rejection (aHR 1.8, 1.6-2.0) were significant risk factors for developing CMV infection, while mycophenolate mofetil <1500 mg (aHR 0.52, 0.47-0.59), mammalian target of rapamycin inhibitor (mTORi) conversion (0.77, 0.56-0.89), cyclosporine-A conversion (aHR 0.68, 0.56-0.84) were associated with lower risk of CMV infection. CONCLUSION:Increasing use of potent immunosuppression coupled with higher CMV D+/R- F rates may be driving higher rates of CMV infection. Cyclosporine and mTORi conversion appears to be protective against CMV. A more individualized immunosuppression regimen based on infection risk merits consideration.

As healthcare continues its transition toward value-based care, it is increasingly important for transplant pharmacists to demonstrate their impact on patient care, health-related outcomes, and healthcare costs. Evidence-based quality and performance metrics are recognized as crucial tools for measuring the value of service. Yet, there is a lack of well-developed and agreed-upon specific metrics for many clinical pharmacy specialties, including solid organ transplantation. To address this need, a panel of transplant pharmacy specialists conducted a detailed literature review and engaged in several panel discussions to identify quality metrics to be considered for assessing the value of clinical pharmacy services provided to solid organ transplant recipients and living donors. The proposed metrics are based on the Donabedian model and are categorized to coincide with the typical phases of transplant care. The measures focus on key issues that arise in transplant recipients related to medication therapy, including adverse drug events, nonadherence, and clinical outcomes attributable to medication therapy management. This article proposes a comprehensive set of measures, any number of which transplant pharmacists can adopt and measure over time to objectively gauge the value of services they are providing to transplant recipients, the transplant center, and the overall healthcare system.