scholarly journals Improving Transplant Medication Safety Through a Pharmacist-Empowered, Patient-Centered, mHealth-Based Intervention: TRANSAFE Rx Study Protocol (Preprint)

2017 ◽  
Author(s):  
James N Fleming ◽  
Frank Treiber ◽  
John McGillicuddy ◽  
Mulugeta Gebregziabher ◽  
David J Taber
Keyword(s):  
Clinical Trial ◽  
Kidney Transplant ◽  
Outcome Measures ◽  
Medication Safety ◽  
Graft Loss ◽  
Graft Function ◽  
Economic Effectiveness ◽  
Controlled Clinical Trial ◽  
Transplant Recipients ◽  
Kidney Transplant Recipients

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)

scholarly journals Trends in the Causes of Death among Kidney Transplant Recipients in the United States (1996–2014)

2018 ◽  
Vol 48 (6) ◽  
pp. 472-481 ◽  
Author(s):  
Ahmed A. Awan ◽  
Jingbo Niu ◽  
Jenny S. Pan ◽  
Kevin F. Erickson ◽  
Sreedhar Mandayam ◽  
...  
Keyword(s):  
United States ◽  
Kidney Transplant ◽  
Cardiovascular Mortality ◽  
Causes Of Death ◽  
Graft Loss ◽  
Graft Function ◽  
The United States ◽  
Mortality Data ◽  
Transplant Recipients ◽  
Kidney Transplant Recipients

Background: Death with graft function remains an important cause of graft loss among kidney transplant recipients (KTRs). Little is known about the trend of specific causes of death in KTRs in recent years. Methods: We analyzed United States Renal Data System data (1996–2014) to determine 1- and 10-year all-cause and cause-specific mortality in adult KTRs who died with a functioning allograft. We also studied 1- and 10-year trends in the various causes of mortality. Results: Of 210,327 KTRs who received their first kidney transplant from 1996 to 2014, 3.2% died within 1 year after transplant. Cardiovascular deaths constituted the majority (24.7%), followed by infectious (15.2%) and malignant (2.9%) causes; 40.1% of deaths had no reported cause. Using 1996 as the referent year, all-cause as well as cardiovascular mortality declined, whereas mortality due to malignancy did not. For analyses of 10-year mortality, we studied 94,384 patients who received a first kidney transplant from 1996 to 2005. Of those, 22.1% died over 10 years and the causative patterns of their causes of death were similar to those associated with 1-year mortality. Conclusions: Despite the downtrend in mortality over the last 2 decades, a significant percentage of KTRs die in 10-years with a functioning graft, and cardiovascular mortality remains the leading cause of death. These data also highlight the need for diligent collection of mortality data in KTRs.

scholarly journals Obesity affects graft function but not graft loss in kidney transplant recipients

2020 ◽  
Vol 48 (1) ◽  
pp. 030006051989513
Author(s):  
Maria Irene Bellini ◽  
Kostas Koutroutsos ◽  
Hannah Nananpragasam ◽  
Emily Deurloo ◽  
Jack Galliford ◽  
...  
Keyword(s):  
Kidney Transplant ◽  
Graft Loss ◽  
Graft Function ◽  
Transplant Recipients ◽  
Kidney Transplant Recipients

scholarly journals Long-Term Outcomes after Acute Rejection in Kidney Transplant Recipients: An ANZDATA Analysis

2019 ◽  
Vol 30 (9) ◽  
pp. 1697-1707 ◽  
Author(s):  
Philip A. Clayton ◽  
Stephen P. McDonald ◽  
Graeme R. Russ ◽  
Steven J. Chadban
Keyword(s):  
Cardiovascular Disease ◽  
Acute Rejection ◽  
Kidney Transplant ◽  
Graft Loss ◽  
Graft Function ◽  
High Rate ◽  
Sensitivity Analyses ◽  
Transplant Recipients ◽  
Kidney Transplant Recipients

BackgroundDeclining rates of acute rejection (AR) and the high rate of 1-year graft survival among patients with AR have prompted re-examination of AR as an outcome in the clinic and in trials. Yet AR and its treatment may directly or indirectly affect longer-term outcomes for kidney transplant recipients.MethodsTo understand the long-term effect of AR on outcomes, we analyzed data from the Australia and New Zealand Dialysis and Transplant Registry, including 13,614 recipients of a primary kidney-only transplant between 1997 and 2017 with at least 6 months of graft function. The associations between AR within 6 months post-transplant and subsequent cause-specific graft loss and death were determined using Cox models adjusted for baseline donor, recipient, and transplant characteristics.ResultsAR occurred in 2906 recipients (21.4%) and was associated with graft loss attributed to chronic allograft nephropathy (hazard ratio [HR], 1.39; 95% confidence interval [95% CI], 1.23 to 1.56) and recurrent AR beyond month 6 (HR, 1.85; 95% CI, 1.39 to 2.46). Early AR was also associated with death with a functioning graft (HR, 1.22; 95% CI, 1.08 to 1.36), and with death due to cardiovascular disease (HR, 1.30; 95% CI, 1.11 to 1.53) and cancer (HR, 1.35; 95% CI, 1.12 to 1.64). Sensitivity analyses restricted to subgroups with either biopsy-proven, antibody-mediated, or vascular rejection, or stratified by treatment response produced similar results.ConclusionsAR is associated with increased risks of longer-term graft failure and death, particularly death from cardiovascular disease and cancer. The results suggest AR remains an important short-term outcome to monitor in kidney transplantation and clinical trials.

scholarly journals Conversion from Calcineurin Inhibitor– to Belatacept-Based Maintenance Immunosuppression in Renal Transplant Recipients: A Randomized Phase 3b Trial

2021 ◽  
Vol 32 (12) ◽  
pp. 3252-3264
Author(s):  
Klemens Budde ◽  
Rohini Prashar ◽  
Hermann Haller ◽  
Maria C. Rial ◽  
Nassim Kamar ◽  
...  
Keyword(s):  
Renal Transplant ◽  
Adverse Events ◽  
Kidney Transplant ◽  
De Novo ◽  
Graft Loss ◽  
Graft Function ◽  
Renal Transplant Recipients ◽  
Transplant Recipients ◽  
Kidney Transplant Recipients ◽  
Maintenance Immunosuppression

BackgroundCalcineurin inhibitors (CNIs) are standard of care after kidney transplantation, but they are associated with nephrotoxicity and reduced long-term graft survival. Belatacept, a selective T cell costimulation blocker, is approved for the prophylaxis of kidney transplant rejection. This phase 3 trial evaluated the efficacy and safety of conversion from CNI-based to belatacept-based maintenance immunosuppression in kidney transplant recipients.MethodsStable adult kidney transplant recipients 6–60 months post-transplantation under CNI-based immunosuppression were randomized (1:1) to switch to belatacept or continue treatment with their established CNI. The primary end point was the percentage of patients surviving with a functioning graft at 24 months.ResultsOverall, 446 renal transplant recipients were randomized to belatacept conversion (n=223) or CNI continuation (n=223). The 24-month rates of survival with graft function were 98% and 97% in the belatacept and CNI groups, respectively (adjusted difference, 0.8; 95.1% CI, −2.1 to 3.7). In the belatacept conversion versus CNI continuation groups, 8% versus 4% of patients experienced biopsy-proven acute rejection (BPAR), respectively, and 1% versus 7% developed de novo donor-specific antibodies (dnDSAs), respectively. The 24-month eGFR was higher with belatacept (55.5 versus 48.5 ml/min per 1.73 m2 with CNI). Both groups had similar rates of serious adverse events, infections, and discontinuations, with no unexpected adverse events. One patient in the belatacept group had post-transplant lymphoproliferative disorder.ConclusionsSwitching stable renal transplant recipients from CNI-based to belatacept-based immunosuppression was associated with a similar rate of death or graft loss, improved renal function, and a numerically higher BPAR rate but a lower incidence of dnDSA.Clinical Trial registry name and registration number: A Study in Maintenance Kidney Transplant Recipients Following Conversion to Nulojix® (Belatacept)-Based, NCT01820572

Using informatics and mobile health to improve medication safety monitoring in kidney transplant recipients

2019 ◽  
Vol 76 (15) ◽  
pp. 1143-1149 ◽  
Author(s):  
David J Taber ◽  
Nicole A Pilch ◽  
John W McGillicuddy ◽  
Caitlin Mardis ◽  
Frank Treiber ◽  
...  
Keyword(s):  
Kidney Transplant ◽  
Medication Safety ◽  
Retention Rate ◽  
Controlled Trial ◽  
Intervention Group ◽  
Safety Monitoring ◽  
Controlled Clinical Trial ◽  
Transplant Recipients ◽  
Kidney Transplant Recipients ◽  
Randomized Controlled

Abstract Purpose The development, testing, and preliminary validation of a technology-enabled, pharmacist-led intervention aimed at improving medication safety and outcomes in kidney transplant recipients are described. Summary Medication safety issues, encompassing medication errors (MEs), medication nonadherence, and adverse drug events (ADEs), are a predominant cause of poor outcomes after kidney transplantation. However, a limited number of clinical trials assessing the effectiveness of technology in improving medication safety and outcomes in transplant recipients have been conducted. Through an iterative, evidence-based approach, a technology-enabled intervention aimed at improving posttransplant medication safety outcomes was developed, tested, and preliminarily validated. Early acceptability and feasibility results from a prospective, randomized controlled trial assessing the effectiveness of this system are reported here. Of the 120 patients enrolled into the trial at the time of writing, 60 were randomly assigned to receive the intervention. At a mean ± S.D. follow-up of 5.8 ± 4.0 months, there were 2 patient dropouts in the intervention group, resulting in a retention rate of 98%, which was higher than the expected 90% retention rate. Conclusion The development and deployment of a comprehensive medication safety monitoring dashboard for kidney transplant recipients is feasible and acceptable to patients in the current healthcare environment. An ongoing randomized controlled clinical trial is assessing whether such a system reduces MEs and ADRs, leading to improved patient outcomes.

Immunosuppressive Management of Pediatric Kidney Transplant Recipients

2020 ◽  
Vol 26 (28) ◽  
pp. 3451-3459
Author(s):  
Tomáš Seeman
Keyword(s):  
Immunosuppressive Therapy ◽  
Kidney Transplant ◽  
Induction Therapy ◽  
Graft Loss ◽  
Calcineurin Inhibitors ◽  
Mtor Inhibitors ◽  
Therapeutic Drug ◽  
High Dose ◽  
Transplant Recipients ◽  
Kidney Transplant Recipients

: Kidney transplantation is a preferable treatment of children with end-stage kidney disease. All kidney transplant recipients, including pediatric need immunosuppressive medications to prevent rejection episodes and graft loss. : Induction therapy is used temporarily only immediately following transplantation while maintenance immunosuppressive drugs are started and given long-term. There is currently no consensus regarding the use of induction therapy in children; its use should be decided based on the immunological risk of the child. : The recent progress shows that the recommended strategy is to use as maintenance immunosuppressive therapy a combination of a calcineurin inhibitor (preferably tacrolimus) with an antiproliferative drug (preferably mycophenolate mofetil) with steroids that can be withdrawn early or late in low-risk children. The mTOR-inhibitors (sirolimus, everolimus) are used rarely in pediatrics because of common side effects and no evidence of a benefit over calcineurin inhibitors. The use of calcineurin inhibitors, mycophenolate, and mTOR-inhibitors should be followed by therapeutic drug monitoring. : Immunosuppressive therapy of acute rejection consists of high-dose steroids and/or anti-lymphocyte antibodies (T-cell mediated rejection) or plasma exchange, intravenous immunoglobulines and/or rituximab (antibodymediated rejection). : The future strategies for research are mainly precise characterisation of children needing induction therapy, more specific indications for mTOR-inhibitors and for the far future, the possibility to reach the immuno tolerance.

scholarly journals BK Polyomavirus Micro-RNAs: Time Course and Clinical Relevance in Kidney Transplant Recipients

Viruses ◽  
2021 ◽  
Vol 13 (2) ◽  
pp. 351
Author(s):  
Baptiste Demey ◽  
Véronique Descamps ◽  
Claire Presne ◽  
Francois Helle ◽  
Catherine Francois ◽  
...  
Keyword(s):  
Viral Replication ◽  
Kidney Transplant ◽  
Clinical Relevance ◽  
Graft Loss ◽  
First Year ◽  
Transplant Recipients ◽  
Kidney Transplant Recipients ◽  
Post Transplantation ◽  
Bk Polyomavirus ◽  
Micro Rnas

Background: Kidney transplant recipients (KTRs) are exposed to a high risk of BK polyomavirus (BKPyV) replication, which in turn may lead to graft loss. Although the microRNAs (miRNAs) bkv-miR-B1-3p and bkv-miR-B1-5p are produced during the viral cycle, their putative value as markers of viral replication has yet to be established. In KTRs, the clinical relevance of the changes over time in BKPyV miRNA levels has not been determined. Methods: In a retrospective study, we analyzed 186 urine samples and 120 plasma samples collected from 67 KTRs during the first year post-transplantation. Using a reproducible, standardized, quantitative RT-PCR assay, we measured the levels of bkv-miR-B1-3p and bkv-miR-B1-5p (relative to the BKPyV DNA load). Results: Detection of the two miRNAs had low diagnostic value for identifying patients with DNAemia or for predicting DNAuria during follow-up. Seven of the 14 KTRs with a sustained BKPyV infection within the first year post-transplantation showed a progressive reduction in the DNA load and then a rapid disappearance of the miRNAs. DNA and miRNA loads were stable in the other seven KTRs. Conclusions: After the DNA-based diagnosis of BKPyV infection in KTRs, bkv-miR-B1-3p and bkv-miR-B1-5p levels in the urine might be valuable markers for viral replication monitoring and thus might help physicians to avoid an excessive reduction in the immunosuppressive regimen.

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