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1.
Front Nephrol ; 4: 1352363, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-38476464

RESUMEN

Introduction: Wound complications can cause considerable morbidity in kidney transplantation. Closed-incision negative pressure wound therapy (ciNPWT) systems have been efficacious in reducing wound complications across surgical specialties. The aims of this study were to evaluate the use of ciNPWT, Prevena™, in kidney transplant recipients and to determine any association with wound complications. Material and methods: A single-center, prospective observational cohort study was performed in 2018. A total of 30 consecutive kidney transplant recipients deemed at high risk for wound complications received ciNPWT, and the results were compared to those of a historical cohort of subjects who received conventional dressings. Analysis for recipients with obesity and propensity score matching were performed. Results: In total, 127 subjects were included in the analysis. Of these, 30 received a ciNPWT dressing and were compared with 97 subjects from a non-study historical control group who had conventional dressing. The overall wound complication rate was 21.3% (27/127). There was no reduction in the rate of wound complications with ciNPWT when compared with conventional dressing [23.3% (7/30) and 20.6% (20/97), respectively, p = 0.75]. In the obese subset (BMI ≥30 kg/m2), there was no significant reduction in wound complications [31.1% (5/16) and 36.8% (7/19), respectively, p = 0.73]. Propensity score matching yielded 26 matched pairs with equivalent rates of wound complications (23.1%, 6/26). Conclusion: This is the first reported cohort study evaluating the use of ciNPWT in kidney transplantation. While ciNPWT is safe and well tolerated, it is not associated with a statistically significant reduction in wound complications when compared to conventional dressing. The findings from this study will be used to inform future studies associated with ciNPWT in kidney transplantation.

2.
Transplantation ; 2023 Nov 09.
Artículo en Inglés | MEDLINE | ID: mdl-37941113

RESUMEN

Chronic active antibody-mediated rejection (caAMR) is arguably the most important cause of late kidney allograft failure. However, there are no US Food and Drug Administration (FDA)-approved treatments for acute or chronic AMR and there is no consensus on effective treatment. Many trials in transplantation have failed because of slow and/or inadequate enrollment, and no new agent has been approved by the FDA for transplantation in over a decade. Several lines of evidence suggest that interleukin-6 is an important driver of AMR, and clazakizumab, a humanized monoclonal antibody that neutralizes interleukin-6, has shown promising results in phase 2 studies. The IMAGINE trial (Interleukin-6 Blockade Modifying Antibody-mediated Graft Injury and Estimated Glomerular Filtration Rate Decline) (NCT03744910) is the first to be considered by the FDA using a reasonably likely surrogate endpoint (slope of estimated glomerular filtration rate decline >1 y) for accelerated approval and is the only ongoing clinical trial for the treatment of chronic rejection. This trial offers us the opportunity to advance the care for our patients in need, and this article is a call to action for all transplant providers caring for patients with caAMR.

3.
JAMA ; 330(13): 1266-1277, 2023 10 03.
Artículo en Inglés | MEDLINE | ID: mdl-37787795

RESUMEN

Importance: Chronic kidney disease (low estimated glomerular filtration rate [eGFR] or albuminuria) affects approximately 14% of adults in the US. Objective: To evaluate associations of lower eGFR based on creatinine alone, lower eGFR based on creatinine combined with cystatin C, and more severe albuminuria with adverse kidney outcomes, cardiovascular outcomes, and other health outcomes. Design, Setting, and Participants: Individual-participant data meta-analysis of 27 503 140 individuals from 114 global cohorts (eGFR based on creatinine alone) and 720 736 individuals from 20 cohorts (eGFR based on creatinine and cystatin C) and 9 067 753 individuals from 114 cohorts (albuminuria) from 1980 to 2021. Exposures: The Chronic Kidney Disease Epidemiology Collaboration 2021 equations for eGFR based on creatinine alone and eGFR based on creatinine and cystatin C; and albuminuria estimated as urine albumin to creatinine ratio (UACR). Main Outcomes and Measures: The risk of kidney failure requiring replacement therapy, all-cause mortality, cardiovascular mortality, acute kidney injury, any hospitalization, coronary heart disease, stroke, heart failure, atrial fibrillation, and peripheral artery disease. The analyses were performed within each cohort and summarized with random-effects meta-analyses. Results: Within the population using eGFR based on creatinine alone (mean age, 54 years [SD, 17 years]; 51% were women; mean follow-up time, 4.8 years [SD, 3.3 years]), the mean eGFR was 90 mL/min/1.73 m2 (SD, 22 mL/min/1.73 m2) and the median UACR was 11 mg/g (IQR, 8-16 mg/g). Within the population using eGFR based on creatinine and cystatin C (mean age, 59 years [SD, 12 years]; 53% were women; mean follow-up time, 10.8 years [SD, 4.1 years]), the mean eGFR was 88 mL/min/1.73 m2 (SD, 22 mL/min/1.73 m2) and the median UACR was 9 mg/g (IQR, 6-18 mg/g). Lower eGFR (whether based on creatinine alone or based on creatinine and cystatin C) and higher UACR were each significantly associated with higher risk for each of the 10 adverse outcomes, including those in the mildest categories of chronic kidney disease. For example, among people with a UACR less than 10 mg/g, an eGFR of 45 to 59 mL/min/1.73 m2 based on creatinine alone was associated with significantly higher hospitalization rates compared with an eGFR of 90 to 104 mL/min/1.73 m2 (adjusted hazard ratio, 1.3 [95% CI, 1.2-1.3]; 161 vs 79 events per 1000 person-years; excess absolute risk, 22 events per 1000 person-years [95% CI, 19-25 events per 1000 person-years]). Conclusions and Relevance: In this retrospective analysis of 114 cohorts, lower eGFR based on creatinine alone, lower eGFR based on creatinine and cystatin C, and more severe UACR were each associated with increased rates of 10 adverse outcomes, including adverse kidney outcomes, cardiovascular diseases, and hospitalizations.


Asunto(s)
Albúminas , Albuminuria , Creatinina , Cistatina C , Tasa de Filtración Glomerular , Insuficiencia Renal Crónica , Adulto , Femenino , Humanos , Masculino , Persona de Mediana Edad , Albuminuria/diagnóstico , Albuminuria/epidemiología , Fibrilación Atrial , Creatinina/análisis , Cistatina C/análisis , Estudios Retrospectivos , Insuficiencia Renal Crónica/diagnóstico , Insuficiencia Renal Crónica/epidemiología , Anciano , Albúminas/análisis , Progresión de la Enfermedad , Internacionalidad , Comorbilidad
4.
Nephrology (Carlton) ; 28(11): 639-643, 2023 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-37635271

RESUMEN

We present the case of a recent ABO incompatible kidney transplant recipient with persistent SARS-CoV-2 infection and pneumonitis. Serial whole genome sequencing confirmed intra-host viral evolution, which was used as a surrogate to confirm active viral replication and support re-treatment with antivirals, late in the course of infection. A prolonged course of remdesivir combined with immunosuppression modulation resulted in successful clearance of virus and clinical improvement. The diagnostic process undertaken in this case provides a useful guide for other clinicians when approaching similar patients.


Asunto(s)
COVID-19 , Trasplante de Riñón , Neumonía , Humanos , Sistema del Grupo Sanguíneo ABO , Incompatibilidad de Grupos Sanguíneos , COVID-19/diagnóstico , Rechazo de Injerto , Terapia de Inmunosupresión , Trasplante de Riñón/efectos adversos , Trasplante de Riñón/métodos , SARS-CoV-2/genética , Masculino , Persona de Mediana Edad , Antivirales/uso terapéutico , Neumonía/tratamiento farmacológico
6.
Transplantation ; 107(7): 1593-1604, 2023 07 01.
Artículo en Inglés | MEDLINE | ID: mdl-36959121

RESUMEN

BACKGROUND: The comparative impact of everolimus (EVR)-based regimens versus standard of care (mycophenolic acid+standard calcineurin inhibitor [MPA+sCNI]) on cardiovascular outcomes in de novo kidney transplant recipients (KTRs) is poorly understood. The incidence of major adverse cardiac events (MACEs) in KTRs receiving EVR+reduced CNI (rCNI) or MPA+sCNI from the TRANSplant eFficacy and safety Outcomes with an eveRolimus-based regiMen study was evaluated. METHODS: The incidence of MACE was determined for all randomized patients receiving at least 1 dose of the study drug. Factors associated with MACEs were determined by logistic regression. Risk of MACE out to 3 y post-study was calculated using the Patient Outcome in Renal Transplantation equation. RESULTS: MACE occurred in 81 of 1014 (8.0%; EVR+rCNI) versus 89 of 1012 (8.8%; MPA+sCNI) KTRs (risk ratio, 0.91 [95% confidence interval [CI], 0.68-1.21]). The incidence of circulatory death, myocardial infarction, revascularization, or angina was similar between the arms. Incidence of MACE was similar between EVR+rCNI and MPA+sCNI arms with a higher incidence in prespecified risk groups: older age, pretransplant diabetes (15.1% versus 15.9%), statin use (8.5% versus 10.8%), and low estimated glomerular filtration rate (Month 2 estimated glomerular filtration rate <30 versus >60 mL/min/1.73 m 2 ; odds ratio, 2.23 [95% CI, 1.02-4.86]; P = 0.044), respectively. Predicted risk of MACE within 3 y of follow-up did not differ between the treatment arms. CONCLUSIONS: Cardiovascular morbidity and mortality were similar between de novo KTRs receiving EVR+rCNI and MPA+sCNI. EVR+rCNI is a viable alternative to the current standard of care in KTRs.


Asunto(s)
Everolimus , Trasplante de Riñón , Humanos , Everolimus/efectos adversos , Inhibidores de la Calcineurina/efectos adversos , Inmunosupresores/efectos adversos , Trasplante de Riñón/efectos adversos , Nivel de Atención , Ácido Micofenólico/uso terapéutico , Tasa de Filtración Glomerular , Rechazo de Injerto/etiología , Tacrolimus/efectos adversos
7.
Clin Transplant ; 37(5): e14945, 2023 05.
Artículo en Inglés | MEDLINE | ID: mdl-36807636

RESUMEN

INTRODUCTION: Demand for donor kidneys far exceeds the availability of organs from deceased donors. Living donor kidneys are an important part of addressing this shortfall, and laparoscopic nephrectomy is an important strategy to reduce donor morbidity and increase the acceptability of living donation. AIM: To retrospectively review the intraoperative and postoperative safety, technique, and outcomes of patients undergoing donor nephrectomy at a single tertiary hospital in Sydney, Australia. METHOD: Retrospective capture and analysis of clinical, demographic, and operative data for all living donor nephrectomies performed between 2007 and 2022 at a single University Hospital in Sydney, Australia. RESULTS: Four hundred and seventy-two donor nephrectomies were performed: 471 were laparoscopic, two of which were converted from laparoscopic to open and hand-assisted nephrectomy, respectively, and one (.2%) underwent primary open nephrectomy. The mean warm ischemia time was 2.8 min (±1.3 SD, median 3 min, range 2-8 min) and the mean length of stay (LOS) was 4.1 days (±1.0 SD). The mean renal function on discharge was 103 µmol/L (±23.0 SD). Seventy-seven (16%) patients had a complication with no Clavien Dindo IV or V complications seen. Outcomes demonstrated no impact of donor age, gender, kidney side, relationship to the recipient, vascular complexity; or surgeon experience, on complication rate or LOS. CONCLUSION: Laparoscopic donor nephrectomy is a safe and effective procedure with minimal morbidity and no mortality in this series.


Asunto(s)
Trasplante de Riñón , Laparoscopía , Donadores Vivos , Nefrectomía , Humanos , Australia , Riñón/fisiología , Riñón/cirugía , Laparoscopía/métodos , Nefrectomía/métodos , Estudios Retrospectivos , Recolección de Tejidos y Órganos/métodos
8.
Trials ; 23(1): 1042, 2022 Dec 22.
Artículo en Inglés | MEDLINE | ID: mdl-36550562

RESUMEN

BACKGROUND: Chronic active antibody-mediated rejection (AMR) is a major cause of graft loss with no approved drugs for its treatment. Currently, off-label regimens are used, reflecting the high unmet need for effective therapies based on well-controlled trials. Clazakizumab is a high-affinity, humanized monoclonal antibody that binds interleukin-6 and decreases donor-specific antibody (DSA) production and inflammation. Phase 2 pilot studies of clazakizumab in kidney transplant recipients with chronic active AMR suggest modulation of DSA, stabilization of glomerular filtration rate (GFR), and a manageable safety profile. We report the design of the Phase 3 IMAGINE study (NCT03744910) to evaluate the safety and efficacy of clazakizumab for the treatment of chronic active AMR. METHODS: IMAGINE is a multicenter, double-blind trial of approximately 350 kidney transplant recipients with chronic active AMR (Banff chronic glomerulopathy [cg] >0 with concurrent positive human leukocyte antigen DSA) randomized 1:1 to receive clazakizumab or placebo (12.5 mg subcutaneous once every 4 weeks). The event-driven trial design will follow patients until 221 occurrences of all-cause graft loss are observed, defined as return to dialysis, graft nephrectomy, re-transplantation, estimated GFR (eGFR) <15 mL/min/1.73m2, or death from any cause. A surrogate for graft loss (eGFR slope) will be assessed at 1 year based on prior modeling validation. Secondary endpoints will include measures of pharmacokinetics/pharmacodynamics. Recruitment is ongoing across North America, Europe, Asia, and Australia. DISCUSSION: IMAGINE represents the first Phase 3 clinical trial investigating the safety and efficacy of clazakizumab in kidney transplant recipients with chronic active AMR, and the largest placebo-controlled trial in this patient population. This trial includes prognostic biomarker enrichment and uniquely utilizes the eGFR slope at 1 year as a surrogate endpoint for graft loss, which may accelerate the approval of a novel therapy for patients at risk of graft loss. The findings of this study will be fundamental in helping to address the unmet need for novel therapies for chronic active AMR. TRIAL REGISTRATION: ClinicalTrials.gov NCT03744910 . Registered on November 19, 2018.


Asunto(s)
Trasplante de Riñón , Humanos , Trasplante de Riñón/efectos adversos , Anticuerpos Monoclonales Humanizados/efectos adversos , Método Doble Ciego , Tasa de Filtración Glomerular , Rechazo de Injerto/tratamiento farmacológico , Rechazo de Injerto/prevención & control , Isoanticuerpos , Supervivencia de Injerto
9.
Can J Kidney Health Dis ; 9: 20543581221084499, 2022.
Artículo en Inglés | MEDLINE | ID: mdl-35340772

RESUMEN

Background: Numerous factors influence patient recruitment to, and retention on, peritoneal dialysis (PD), but a major challenge is a perceived "inaccessibility" to treating clinicians. It has been suggested that remote patient monitoring (RPM) could be a means of improving such oversight and, thereby, uptake of PD. Objective: To describe patient and clinician perspectives toward RPM and the use of applications (Apps) suitable for mobiles, tablets, or computers to support the provision of PD care. Design: Qualitative design using semi-structured interviews. Setting: All patient participants perform PD treatment at home under the oversight of an urban PD unit in Sydney, Australia. Patient and clinician interviews were conducted within the PD unit. Participants: 14 participants (5 clinicians [2 nephrologists, 3 PD nurses] and 9 patients treated with PD). Methods: Semi-structured interviews were conducted using interview guides tailored for clinician and patient participants. Transcripts were coded and analyzed by a single researcher using thematic analysis. Results: Six themes were identified: perceived benefits of RPM implementation (offering convenience and efficiency, patient assurance through increased surveillance, more complete data and monitoring adherence), uncertainty regarding data governance (protection of personal data, data reliability), reduced patient engagement (transfer of responsibility leading to complacency), changing patient-clinician relationships (reduced patient-initiated communication, the need to maintain patient independence), increased patient and clinician burden (inadequate technological literacy, overmanagement leading to frequent treatment changes), and clinician preference influencing patient behavior. Limitations: The interviews were conducted in English only and with participants from a single urban dialysis unit, which may limit generalizability. Conclusions: For patients and clinicians, advantages from the use of RPM in PD may include increased patient confidence and assurance, improved treatment oversight, more complete data capture, and overcoming barriers to data documentation. Careful patient selection and patient and clinician education may help to optimize the benefits of RPM, maintain patient independence, and reduce the risks of patient disengagement. The use of an App may support RPM; however, participants expressed concerns about increasing the burden on some patients through the use of unfamiliar technology. Human Research Ethics Committee Approval Number: CH62/6/2019-028.


Contexte: De nombreux facteurs influent sur le recrutement et la rétention des patients en dialyse péritonéale (DP); un des principaux défis étant une impression d'« inaccessibilité ¼ aux cliniciens traitants. La télésurveillance des patients (TSP) a été suggérée comme possible moyen d'améliorer le suivi et, par conséquent, l'adhésion des patients à la DP. Objectif: Décrire les points de vue des patients et des cliniciens à l'égard de la TSP et de l'utilisation d'applications adaptées aux téléphones intelligents, aux tablettes ou aux ordinateurs pour aider à la prise en charge de la DP. Type d'étude: Étude qualitative menée par le biais d'entretiens semi-structurés. Cadre: Tous les patients suivant des traitements de DP à domicile sous la supervision de l'unité de DP d'un centre urbain de Sydney (Australie). Les entretiens avec les patients et les cliniciens ont été menés au sein de l'unité de DP. Participants à l'étude: 14 participants, soit 5 cliniciens (2 néphrologues, 3 infirmières et infirmiers en DP) et 9 patients sous DP. Méthodologie: Des entretiens semi-structurés ont été menés à l'aide de guides d'entrevue adaptés aux cliniciens et aux patients participants. Les transcriptions ont été codées, puis une analyse thématique par un seul chercheur a été réalisée. Résultats: Six thèmes ont été dégagés : 1) avantages perçus de la TSP (intervention pratique et efficace, patients rassurés par une surveillance accrue, données plus complètes et meilleur suivi de l'observance); 2) incertitude quant à la gouvernance des données (protection des données personnelles, fiabilité des données); 3) réduction de la participation des patients (transfert de responsabilité menant à la complaisance); 4) évolution de la relation patient-clinicien (réduction des échanges initiés par le patient, nécessité de maintenir l'indépendance du patient); 5) fardeau accru pour le patient et le clinicien (connaissances technologiques inadéquates, gestion excessive conduisant à de fréquents changements du traitement) et; 6) comportement du patient influencé par la préférence du clinicien. Limites: Les entretiens ont été menés uniquement en anglais, auprès de participants provenant d'une seule unité de dialyse en centre urbain, ce qui pourrait limiter la généralisabilité des résultats. Conclusion: Selon les patients et les cliniciens interrogés, la TSP en contexte de DP pourrait offrir plusieurs avantages : confiance et assurance accrues pour les patients, meilleure surveillance du traitement, saisie plus complète des données et suppression des entraves liées à la documentation des données. Une sélection rigoureuse des patients et une formation adéquate du patient et du clinicien pourraient contribuer à optimiser les avantages de la TSP, à maintenir l'indépendance du patient et à réduire les risques de désengagement. L'utilisation d'une application pourrait appuyer la TSP; des participants ont cependant exprimé des inquiétudes quant à une augmentation du fardeau pour certains patients moins familiers avec ce type de technologie. Numéro d'approbation du Comité d'éthique pour la recherche sur l'être humain : CH62/6/2019 ­ 028.

10.
Transpl Int ; 35: 10199, 2022.
Artículo en Inglés | MEDLINE | ID: mdl-35185379

RESUMEN

Reduced estimated glomerular filtration rate (eGFR) at 12-months after kidney transplantation is associated with increased risk of allograft loss, but it is uncertain whether donor age and types modify this relationship. Using Australia and New Zealand registry data, multivariable Cox proportional modelling was used to examine the interactive effects between donor age, types and 12-month eGFR on overall allograft loss. We included 11,095 recipients (4,423 received live-donors). Recipients with lowest 12-month eGFR (<30 ml/min/1.73 m2) experienced the greatest risk of allograft loss, with adjusted HR [95% CI) of 2.65 [2.38-2.95] compared to eGFR of 30-60 ml/min/1.73 m2; whereas the adjusted HR for highest eGFR (>60 ml/min/1.73 m2) was 0.67 [0.62-0.74]. The association of 12-month eGFR and allograft loss was modified by donor age (but not donor types) where a higher risk of allograft loss in recipients with lower compared with higher 12-month eGFR being most pronounced in the younger donor age groups (p < 0.01). Recipients with eGFR <30 ml/min/1.73 m2 12-months after transplantation experienced ≥2.5-fold increased risk of overall allograft loss compared to those with eGFR of >60 ml/min/1.73 m2, and the magnitude of the increased risk is most marked among recipients with younger donors. Careful deliberation of other factors including donor age when considering eGFR as a surrogate for clinical endpoints is warranted.


Asunto(s)
Trasplante de Riñón , Aloinjertos , Niño , Tasa de Filtración Glomerular , Rechazo de Injerto , Supervivencia de Injerto , Humanos , Trasplante de Riñón/efectos adversos , Donadores Vivos , Estudios Retrospectivos , Resultado del Tratamiento
11.
J Pain Symptom Manage ; 63(5): 737-746, 2022 05.
Artículo en Inglés | MEDLINE | ID: mdl-34954064

RESUMEN

CONTEXT: Renal Supportive Care Services (RSCS) were introduced in Australia to provide patient-centred care with a focus on better symptom management and improved quality of life in end stage kidney disease (ESKD) patients managed with or without dialysis. While RSCS have demonstrated clinical benefits with reduced length of hospital stay and symptom burden, there is a gap in understanding the experience of patients referred to RSCS. OBJECTIVES: To identify patient attitudes, beliefs, and perspectives on the RSCS. METHODS: Qualitative interviews were conducted with 20 participants from both dialysis and conservative treatment pathways. Transcripts were then thematically analysed and primary themes identified, which were reviewed with a stakeholder group that included doctors, nurses and allied health staff to provide triangulation. RESULTS: Patients perceived the RSCS as a provider of multidisciplinary, holistic and patient-centred care that, in addition, helped to ensure prognostic awareness and timely end-of-life care planning. This contributed to an overall sense of patient empowerment with healthcare decisions. This study identified three major themes: (1) Expectations of care; (2) Experience of care; and (3) Understanding patient needs. CONCLUSION: The study found that RSCS support patient-centred and family-orientated initiatives in decision making and control over healthcare management. This is empowering for patients. Additional patient values, needs and wants from the RSCS were also identified and these could be addressed to improve the patient experience. Our findings support the ongoing use of RSCS to improve the experience of ESKD patients.


Asunto(s)
Fallo Renal Crónico , Calidad de Vida , Australia , Femenino , Hospitales de Enseñanza , Humanos , Fallo Renal Crónico/terapia , Masculino , Evaluación del Resultado de la Atención al Paciente , Investigación Cualitativa , Diálisis Renal
12.
BMJ Open ; 11(10): e052138, 2021 10 07.
Artículo en Inglés | MEDLINE | ID: mdl-34620664

RESUMEN

OBJECTIVES: Development of pharmaceutical agents in transplantation is currently limited by long waits for hard endpoints. We applied a validated integrative risk-prognostication system integrative Box (iBox) as a surrogate endpoint to the TRANSFORM Study, a large randomised controlled trial, to project individual patient long-term kidney allograft survival from 1 year to 11 years after randomisation. DESIGN: Post-hoc analysis of a randomised open-label controlled trial. SETTING: Multicentre study including 186 centres in 42 countries worldwide. PARTICIPANTS: 2037 de novo kidney transplant recipients. INTERVENTION: Participants were randomised (1:1) to receive everolimus with reduced-exposure calcineurin inhibitor (EVR+rCNI) or mycophenolic acid with standard-exposure CNI (MPA+sCNI). PRIMARY OUTCOME MEASURE: The iBox scores were computed for each participant at 1 year after randomisation using functional, immunological and histological parameters. Individual long-term death-censored allograft survival over 4, 6 and 11 years after randomisation was projected with the iBox risk-prognostication system. RESULTS: Overall, 940 patients receiving EVR+rCNI and 932 receiving MPA+sCNI completed the 1-year visit. iBox scores generated at 1 year yielded graft survival prediction rates of 90.9% vs 92.1%, 87.9% vs 89.5%, and 80.0% vs 82.4% in the EVR+rCNI versus MPA+sCNI arms at 4, 6, and 11 years post-randomisation, respectively (all differences below the 10% non-inferiority margin defined by study protocol). Inclusion of immunological and histological Banff diagnoses parameters in iBox scores resulted in comparable and non-inferior predicted graft survival for both treatments. CONCLUSIONS: This proof-of-concept study provides the first application of a validated prognostication system as a surrogate endpoint in the field of transplantation. The iBox system, by projecting kidney allograft survival up to 11 years post-randomisation, confirms the non-inferiority of EVR+rCNI versus MPA+sCNI regimen. Given the current process engaged for surrogate endpoints qualification, this study illustrates the potential to fast track development of pharmaceutical agents. TRIAL REGISTRATION NUMBER: TRANSFORM trial: NCT01950819.iBox prognostication system: NCT03474003.


Asunto(s)
Trasplante de Riñón , Biomarcadores , Inhibidores de la Calcineurina , Everolimus , Humanos , Ácido Micofenólico/uso terapéutico
13.
Transpl Int ; 34(12): 2431-2441, 2021 12.
Artículo en Inglés | MEDLINE | ID: mdl-34626503

RESUMEN

Delayed graft function (DGF) after kidney transplantation is associated with inferior outcomes and higher healthcare costs. DGF is currently defined as the requirement for dialysis within seven days post-transplant; however, this definition is subjective and nonspecific. Novel biomarkers have potential to improve objectivity and enable earlier diagnosis of DGF. We reviewed the literature to describe the range of novel biomarkers previously studied to predict DGF. We identified marked heterogeneity and low reporting quality of published studies. Among the novel biomarkers, serum NGAL had the greatest potential as a biomarker to predict DGF, but requires further assessment and validation through larger scale studies of diagnostic test performance. Given inadequacies in the dialysis-based definition, coupled with the high incidence and impact of DGF, such studies should be pursued.


Asunto(s)
Pruebas Diagnósticas de Rutina , Trasplante de Riñón , Proteínas de Fase Aguda , Biomarcadores , Funcionamiento Retardado del Injerto/diagnóstico , Supervivencia de Injerto , Humanos , Riñón , Lipocalina 2 , Lipocalinas , Proteínas Proto-Oncogénicas
15.
BMC Urol ; 21(1): 87, 2021 Jun 07.
Artículo en Inglés | MEDLINE | ID: mdl-34098936

RESUMEN

BACKGROUND: Kaposi's sarcoma is an uncommon complication in renal transplant patients, and typically presents with cutaneous lesions on the lower extremities. Penile involvement has been reported only rarely. Management of cutaneous-limited disease is primarily reduction of immunosuppression and conversion to an mTOR-inhibitor, whereas the treatment of disseminated disease in transplant patients is more variable. CASE PRESENTATION: A 75-year-old male, originally from Somalia, received a deceased-donor kidney transplant for diabetic and hypertensive nephropathy. Seven months post-transplant he presented with lower limb lesions, oedema and bilateral deep vein thromboses. He then developed a fast-growing painful lesion on his penile shaft. A biopsy of this lesion confirmed KS, and a PET scan demonstrated disseminated disease in the lower extremities, penis and thoracic lymph nodes. His tacrolimus was converted to sirolimus, and his other immunosuppression was reduced. He was treated with single agent paclitaxel chemotherapy in view of his rapidly progressing, widespread disease. The penile lesion completely resolved, and the lower extremity lesions regressed significantly. His kidney allograft function remained stable throughout treatment. CONCLUSION: This case illustrates a rare presentation of an uncommon post-transplant complication and highlights the need for a high index of suspicion of KS in transplant patients presenting with atypical cutaneous lesions. It serves to demonstrate that the use of single agent paclitaxel chemotherapy, switch to an mTORi and reduction in immunosuppression where possible produces excellent short-term outcomes, adding to the body of evidence for this management strategy in disseminated Kaposi's sarcoma.


Asunto(s)
Antineoplásicos Fitogénicos/uso terapéutico , Trasplante de Riñón , Paclitaxel/uso terapéutico , Neoplasias del Pene/tratamiento farmacológico , Complicaciones Posoperatorias/tratamiento farmacológico , Sarcoma de Kaposi/tratamiento farmacológico , Anciano , Humanos , Masculino
16.
Transpl Int ; 34(8): 1517-1529, 2021 08.
Artículo en Inglés | MEDLINE | ID: mdl-34115918

RESUMEN

The COVID-19 pandemic has challenged the delivery of health services. Telehealth allows delivery of care without in-person contacts and minimizes the risk of vial transmission. We aimed to describe the perspectives of kidney transplant recipients on the benefits, challenges, and risks of telehealth. We conducted five online focus groups with 34 kidney transplant recipients who had experienced a telehealth appointment. Transcripts were thematically analyzed. We identified five themes: minimizing burden (convenient and easy, efficiency of appointments, reducing exposure to risk, limiting work disruptions, and alleviating financial burden); attuning to individual context (depending on stability of health, respect patient choice of care, and ensuring a conducive environment); protecting personal connection and trust (requires established rapport with clinicians, hampering honest conversations, diminished attentiveness without incidental interactions, reassurance of follow-up, and missed opportunity to share lived experience); empowerment and readiness (increased responsibility for self-management, confidence in physical assessment, mental preparedness, and forced independence); navigating technical challenges (interrupted communication, new and daunting technologies, and cognizant of patient digital literacy). Telehealth is convenient and minimizes time, financial, and overall treatment burden. Telehealth should ideally be available after the pandemic, be provided by a trusted nephrologist and supported with resources to help patients prepare for appointments.


Asunto(s)
COVID-19 , Trasplante de Riñón , Telemedicina , Humanos , Pandemias , SARS-CoV-2
18.
Nephrol Dial Transplant ; 36(6): 1048-1056, 2021 05 27.
Artículo en Inglés | MEDLINE | ID: mdl-32170940

RESUMEN

BACKGROUND: Quality-of-life is an essential outcome for clinical care. Both chronic kidney disease (CKD) and diabetes have been associated with poorer quality-of-life. The combined impact of having both diseases is less well understood. As diabetes is the most common cause of CKD, it is imperative that we deepen our understanding of their joint impact. METHODS: This was a prospective, longitudinal cohort study of community-based Australians aged ≥25 years who participated in the Australian Diabetes, Obesity and Lifestyle study. Quality-of-life was measured by physical component summary (PCS) and mental component summary sub-scores of the Short Form (36) Health Survey. Univariate and multivariate linear mixed effect regressions were performed. RESULTS: Of the 11 081 participants with quality-of-life measurements at baseline, 1112 had CKD, 1001 had diabetes and of these 271 had both. Of the 1112 with CKD 421 had Stage 1, 314 had Stage 2, 346 had Stage 3 and 31 had Stages 4/5. Adjusted linear mixed effect models showed baseline PCS was lower for those with both CKD and diabetes compared with either disease alone (P < 0.001). Longitudinal analysis demonstrated a more rapid decline in PCS in those with both diseases. CONCLUSIONS: The combination of CKD and diabetes has a powerful adverse impact on quality-of-life, and participants with both diseases had significantly poorer quality-of-life than those with one condition.


Asunto(s)
Diabetes Mellitus , Insuficiencia Renal Crónica , Australia/epidemiología , Diabetes Mellitus/epidemiología , Humanos , Estudios Prospectivos , Calidad de Vida , Insuficiencia Renal Crónica/epidemiología
19.
Transplant Proc ; 53(1): 136-140, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-32933766

RESUMEN

AIM: Rates of simultaneous liver and kidney transplantation (SLKT) have increased, but indications for SLKT remain poorly defined. Additional data are needed to determine which patients benefit from SLKT to best direct use of scarce donor kidneys. METHODS: Data were extracted from the Australia and New Zealand Dialysis and Transplant Registry (ANZDATA) database for all SLKT performed until the end of 2017. Patients were divided by pretransplant dialysis status into no dialysis before SLKT (preemptive kidney transplant) and any dialysis before SLKT (nonpreemptive). Baseline characteristics and outcomes were compared. RESULTS: Between 1989 and 2017, inclusive, 84 SLKT procedures were performed in Australia, of which 24% were preemptive. Preemptive and nonpreemptive SLKT recipients did not significantly differ in age (P = .267), sex (P = .526), or ethnicity (P = .870). Over a median follow-up time of 4.5 years, preemptively transplanted patients had a statistically equivalent risk of kidney graft failure (hazard ratio (HR) 1.83, 95% confidence interval [CI]: 0.36-12.86, P = .474) and all-cause mortality (HR 1.69, 95% CI: 0.51-5.6, P = .226) compared to nonpreemptive patients. Overall, 1- and 5-year survival rates for all SLKTs were 92% (95% CI: 86-96) and 60% (95% CI: 45-75), respectively. CONCLUSION: Kidney graft and overall patient survival were similar between patients with preemptive kidney transplant and those who were dialysis dependent.


Asunto(s)
Trasplante de Riñón/métodos , Trasplante de Hígado/métodos , Complicaciones Posoperatorias/epidemiología , Adulto , Australia , Femenino , Supervivencia de Injerto , Humanos , Trasplante de Riñón/mortalidad , Trasplante de Hígado/mortalidad , Masculino , Persona de Mediana Edad , Nueva Zelanda , Sistema de Registros , Tasa de Supervivencia
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