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1.
BMC Nephrol ; 24(1): 198, 2023 06 30.
Artículo en Inglés | MEDLINE | ID: mdl-37391713

RESUMEN

BACKGROUND: Ferritin levels are used to make decisions on therapy of iron deficiency in patients with chronic kidney disease (CKD). Hyperferritinaemia, common among patients with CKD from the Northern Territory (NT) of Australia, makes use of ferritin levels as per clinical guidelines challenging. No gold standard assay exists for measuring ferritin levels. Significant variability between results from different assays creates challenges for clinical decision-making regarding iron therapy. In the NT, different laboratories use different methods. In 2018, Territory Pathology changed the assay from Abbott ARCHITECT i1000 (AA) to Ortho-Clinical Diagnostics Vitros 7600 (OCD). This was during the planning of the INtravenous iron polymaltose for First Nations Australian patients with high FERRitin levels on haemodialysis (INFERR) clinical trial. The trial design was based on AA assay ferritin levels. We compared the two assays' level of agreement in measuring ferritin levels in CKD patients. METHODS: Samples from INFERR clinical trial participants were analysed. Other samples from patients whose testing were completed the same day on OCD analyzers and run within 24 h on AA analyzers were added to ensure wide range of ferritin levels, adding statistical strength to the comparison. Ferritin levels from both assays were compared using Pearson's correlation, Bland-Altman, Deming and Passing-Bablok regression analyses. Differences between sample types, plasma and serum were assessed. RESULTS: Sixty-eight and 111 (179) samples from different patients from Central Australia and Top End of Australia, respectively, were analyzed separately and in combination. The ferritin levels ranged from 3.1 µg/L to 3354 µg/L and 3 µg/L to 2170 µg/L for AA and OCD assays respectively. Using Bland-Altman, Deming and Passing-Bablok regression methods for comparison, ferritin results were consistently 36% to 44% higher with AA than OCD assays. The bias was up to 49%. AA ferritin results were the same in serum and plasma. However, OCD ferritin results were 5% higher in serum than plasma. CONCLUSIONS: When making clinical decisions, using ferritin results from the same assay in patients with CKD is critical. If the assay is changed, it is essential to assess agreement between results from the new and old assays. Further studies to harmonize ferritin assays are required.


Asunto(s)
Toma de Decisiones Clínicas , Plasma , Humanos , Administración Intravenosa , Ferritinas , Northern Territory
2.
Intern Med J ; 52(2): 288-294, 2022 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-33251718

RESUMEN

BACKGROUND: Indigenous Australians are disproportionately affected by end stage kidney disease. Despite this, they face significant delays being assessed and waitlisted for kidney transplant. AIMS: To examine the kidney transplant waitlisting process in our region, to compare the workup process between Indigenous Australians and non-Indigenous patients, and identify major sources of delay. METHODS: We analysed the records of all patients being treated by our service who were on the kidney transplant waitlist between January 2017 and June 2018. Between-group differences were used to compare the time between commencement of dialysis and completion of each component of assessment. Patients who had more than 1 year between commencement of dialysis and waitlisting were further analysed for major sources of delay. RESULTS: Twenty-five patients were included (20 Indigenous Australians and 5 non-Indigenous). The median time to waitlisting for transplant after commencing dialysis was significantly longer in the Indigenous group (1215 vs 264 days, P = 0.032). Indigenous Australian patients waited longer before commencing the transplant assessment process and before completing dental assessment, tissue typing and review by the transplant nephrologist and surgeon. Five patients (two Indigenous Australians, three non-Indigenous) were waitlisted within 1 year of commencing dialysis. Among the remaining 20 patients, cardiac and systems issues were the two most common major sources of delay. CONCLUSION: Indigenous Australian patients face significant delays accessing the kidney transplant waitlist. Cardiac assessment and systems issues are prominent sources of delay and efforts to address these areas may help to improve equity of access to kidney transplantation.


Asunto(s)
Servicios de Salud del Indígena , Fallo Renal Crónico , Trasplante de Riñón , Australia/epidemiología , Humanos , Fallo Renal Crónico/cirugía , Nativos de Hawái y Otras Islas del Pacífico , Diálisis Renal
3.
Nephrology (Carlton) ; 27(9): 771-779, 2022 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-35727904

RESUMEN

AIM: To examine whether differences in tacrolimus and mycophenolic acid (MPA) pharmacokinetics contribute to the poorer kidney transplant outcomes experienced by Aboriginal Australians. METHODS: Concentration-time profiles for tacrolimus and MPA were prospectively collected from 43 kidney transplant recipients: 27 Aboriginal and 16 Caucasian. Apparent clearance (CL/F) and distribution volume (V/F) for each individual were derived from concentration-time profiles combined with population pharmacokinetic priors, with subsequent assessment for between-group difference in pharmacokinetics. In addition, population pharmacokinetic models were developed using the prospective dataset supplemented by previously developed structural models for tacrolimus and MPA. The change in NONMEM objective function was used to assess improvement in goodness of model fit. RESULTS: No differences were found between Aboriginal and Caucasian groups or empirical Bayes estimates, for CL/F or V/F of MPA or tacrolimus. However, a higher prevalence of CYP3A5 expressers (26% compared with 0%) and wider between-subject variability in tacrolimus CL/F (SD = 5.00 compared with 3.25 L/h/70 kg) were observed in the Aboriginal group, though these differences failed to reach statistical significance (p = .07 and p = .08). CONCLUSION: There were no differences in typical tacrolimus or MPA pharmacokinetics between Aboriginal and Caucasian kidney transplant recipients. This means that Bayesian dosing tools developed to optimise tacrolimus and MPA dosing in Caucasian recipients may be applied to Aboriginal recipients. In turn, this may improve drug exposure and thereby transplant outcomes in this group. Aboriginal recipients appeared to have greater between-subject variability in tacrolimus CL/F and a higher prevalence of CYP3A5 expressers, attributes that have been linked with inferior outcomes.


Asunto(s)
Inmunosupresores , Trasplante de Riñón , Ácido Micofenólico , Nativos de Hawái y Otras Islas del Pacífico , Tacrolimus , Población Blanca , Australia/epidemiología , Teorema de Bayes , Citocromo P-450 CYP3A/genética , Citocromo P-450 CYP3A/metabolismo , Humanos , Inmunosupresores/farmacocinética , Fallo Renal Crónico/etnología , Fallo Renal Crónico/genética , Fallo Renal Crónico/terapia , Trasplante de Riñón/efectos adversos , Modelos Biológicos , Ácido Micofenólico/farmacocinética , Nativos de Hawái y Otras Islas del Pacífico/etnología , Nativos de Hawái y Otras Islas del Pacífico/genética , Estudios Prospectivos , Tacrolimus/farmacocinética , Receptores de Trasplantes , Población Blanca/etnología , Población Blanca/genética
4.
J Med Virol ; 93(11): 6362-6370, 2021 11.
Artículo en Inglés | MEDLINE | ID: mdl-34173977

RESUMEN

Central Australia is a human T-cell leukemia virus type 1c (HTLV-1c) endemic region and has the highest incidence of chronic kidney disease (CKD) in Australia. The factors associated with HTLV-1 seropositivity among Aboriginal Australian adults with CKD receiving hemodialysis (HD) were determined. A retrospective observational study of Aboriginal adults (≥ 18 years) who were receiving regular HD at the two main dialysis units in Alice Springs, December 1, 2010 to December 31, 2015. Demographic and clinical data before commencing HD were extracted from hospital records from the first presentation to Alice Springs Hospital (ASH) to HD commencement and associations were determined using logistic regression. Among 373 patients receiving HD, 133 (35.9%) were HTLV-1 infected. Identifiable factors associated with HTLV-1 status included increasing age, male gender, and diabetes before HD. The odds of diabetes mellitus were significantly higher among patients with HTLV-1 (adjusted odds ratio [aOR]: 2.76, 95% confidence interval [CI]: 1.19, 6.39; p = 0.017). More than one-fifth of participants had an acute kidney injury, the risk of which was increased among those with a previous blood stream infection (aOR: 3.02, 95% CI: 1.71, 5.34, p < 0.001). Men with a high HTLV-1 proviral load (≥500 copies per 105 peripheral blood leukocytes) had an increased risk of urinary tract infection (UTI) before HD (aOR: 5.15, 95% CI: 1.62, 16.40; p = 0.006). A strong association between HTLV-1 and diabetes, and an increased risk of UTI among men with a high HTLV-1 PVL, suggest that interactions between HTLV-1 infection and conventional risk factors may increase the risk for CKD in this population.


Asunto(s)
Lesión Renal Aguda/etiología , Infecciones por HTLV-I/etiología , Virus Linfotrópico T Tipo 1 Humano/genética , Fallo Renal Crónico/complicaciones , Nativos de Hawái y Otras Islas del Pacífico/estadística & datos numéricos , Infecciones Urinarias/etiología , Lesión Renal Aguda/epidemiología , Adulto , Australia/epidemiología , Estudios Transversales , Femenino , Infecciones por HTLV-I/epidemiología , Infecciones por HTLV-I/virología , Virus Linfotrópico T Tipo 1 Humano/patogenicidad , Humanos , Incidencia , Fallo Renal Crónico/epidemiología , Masculino , Persona de Mediana Edad , Oportunidad Relativa , Provirus/genética , Grupos Raciales , Insuficiencia Renal Crónica/complicaciones , Insuficiencia Renal Crónica/epidemiología , Estudios Retrospectivos , Factores de Riesgo , Infecciones Urinarias/epidemiología , Carga Viral
5.
BMC Nephrol ; 16: 181, 2015 Oct 31.
Artículo en Inglés | MEDLINE | ID: mdl-26520140

RESUMEN

BACKGROUND: This study will assess measures of vascular health and inflammation in Aboriginal Australian adults with chronic kidney disease (CKD), and determine if intensive periodontal intervention improves cardiovascular health, progression of renal disease and periodontal health over a 24-month follow-up. METHODS: The study will be a randomised controlled trial. All participants will receive the periodontal intervention benefits, with the delayed intervention group receiving periodontal treatment 24 months following baseline. Inclusion criteria include being an Aboriginal Australian, having CKD (a. on dialysis; b. eGFR levels of < 60 mls/min/1.73 m(2) (CKD Stages 3 to 5); c. ACR ≥ 30 mg/mmol irrespective of eGFR (CKD Stages 1 and 2); d. diabetes plus albuminuria (ACR ≥ 3 mg/mmol) irrespective of eGFR), having moderate or severe periodontal disease, having at least 12 teeth, and living in Central Australia for the 2-year study duration. The intervention involves intensive removal of dental plaque biofilms by scaling, root-planing and removal of teeth that cannot be saved. The intervention will occur in three visits; baseline, 3-month and 6-month follow-up. The primary outcome will be changes in carotid intima-media thickness (cIMT). Secondary outcomes will include progression of CKD or death as a consequence of CKD/cardiovascular disease. Progression of CKD will be defined by time to the development of the first of: (1) new development of macroalbuminuria; (2) 30 % loss of baseline eGFR; (3) progression to end stage kidney disease defined by eGFR < 15 mLs/min/1.73 m(2); (4) progression to end stage kidney disease defined by commencement of renal replacement therapy. A sample size of 472 is necessary to detect a difference in cIMT of 0.026 mm (SD 0.09) at the significance criterion of 0.05 and a power of 0.80. Allowing for 20 % attrition, 592 participants are necessary at baseline, rounded to 600 for convenience. DISCUSSION: This will be the first RCT evaluating the effect of periodontal therapy on progression of CKD and cardiovascular disease among Aboriginal patients with CKD. Demonstration of a significant attenuation of CKD progression and cardiovascular disease has the potential to inform clinicians of an important, new and widely available strategy for reducing CKD progression and cardiovascular disease for Australia's most disadvantaged population. TRIAL REGISTRATION: This trial is registered with the Australian New Zealand Clinical Trial Registry ANZCTR12614001183673.


Asunto(s)
Enfermedades Cardiovasculares/mortalidad , Nativos de Hawái y Otras Islas del Pacífico/etnología , Nativos de Hawái y Otras Islas del Pacífico/estadística & datos numéricos , Enfermedades Periodontales/mortalidad , Enfermedades Periodontales/terapia , Insuficiencia Renal Crónica/mortalidad , Adulto , Anciano , Anciano de 80 o más Años , Australia/epidemiología , Enfermedades Cardiovasculares/prevención & control , Causalidad , Comorbilidad , Femenino , Humanos , Incidencia , Estudios Longitudinales , Masculino , Persona de Mediana Edad , Pronóstico , Insuficiencia Renal Crónica/prevención & control , Factores de Riesgo , Tasa de Supervivencia , Resultado del Tratamiento , Adulto Joven
7.
Res Involv Engagem ; 10(1): 73, 2024 Jul 15.
Artículo en Inglés | MEDLINE | ID: mdl-39010175

RESUMEN

BACKGROUND: Engagement and partnership with consumers and communities throughout research processes produces high quality research meeting community needs and promoting translation of research into improved policy and practice. Partnership is critical in research involving Aboriginal and/or Torres Strait Islander people (First Nations Peoples) to ensure cultural safety. We present lessons from the design, implementation and progress of the National Health and Medical Research Council funded INtravenous iron polymaltose for First Nations Australian patients with high FERRitin levels on hemodialysis (INFERR) clinical trial. MAIN BODY: The trial was designed to understand the benefits and harms of iron therapy in First Nations Australians on haemodialysis with anaemia and hyperferritinaemia. The lack of evidence for treatment was discussed with patients who were potential participants. A key element ensuring safe conduct of the INFERR trial was the establishment of the Indigenous Reference Groups (IRGs) comprising of dialysis patients based in the Top End of Australia and Central Australia. Two IRGs were needed based on advice from First Nations communities and researchers/academics on the project regarding local cultural differences and approaches to trial conduct. The IRGs underpin culturally safe trial conduct by providing input into study materials and translating study findings into effective messages and policies for First Nations dialysis patients. Throughout the trial conduct, the IRGs' role has developed to provide key mechanisms for advice and guidance regarding research conduct both in this study and more broadly. Support provided to the IRGs by trial First Nations Research Officers and independent First Nations researchers/academics who simplify research concepts is critical. The IRGs have developed feedback documents and processes to participants, stakeholders, and the renal units. They guarantee culturally safe advice for embedding findings from the trial into clinical practice guidelines ensuring evidence-based approaches in managing anaemia in haemodialysis patients with hyperferritinaemia. CONCLUSION: Active consumer and community partnership is critical in research conduct to ensure research impact. Strong partnership with consumers in the INFERR clinical trial has demonstrated that First Nations Consumers will engage in research they understand, that addresses health priorities for them and where they feel respected, listened to, and empowered to achieve change.


In this paper, we present the importance of actively involving consumers in the planning, implementation and conduct of research using the example of a clinical trial among Aboriginal and/or Torres Strait Australians (First Nations Australians) who have kidney disease and are currently receiving haemodialysis. The study assesses how safe and effective it is for people on dialysis to receive iron given through the vein during dialysis when they have anaemia and high levels of a blood test called ferritin, a test used routinely to measure iron levels. Two consumer reference groups of First Nations patients on dialysis, one based in the Top End of Australia and the other based in Central Australia, are supported by First Nations Research Officers and Research Academics to make sure that the research is performed in a way that involves, respects and values First Nations participation, culture, and knowledge. Active consumer and community partnership in this study has supported robust research governance processes which we believe are crucial for knowledge translation to have a positive impact for patients.

8.
Nephrology (Carlton) ; 17 Suppl 1: 5-8, 2012 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-22497646

RESUMEN

To our knowledge, 5 cases of disseminated microsporidiosis with Encephalitozoon species have been reported worldwide in transplant recipients. George et al. present the first such case in Australia, to be reported and treated with good clinical recovery.


Asunto(s)
Encephalitozoon/aislamiento & purificación , Encefalitozoonosis/microbiología , Trasplante de Riñón/efectos adversos , Albendazol/uso terapéutico , Antiinfecciosos/uso terapéutico , Biopsia , Encefalitozoonosis/diagnóstico , Encefalitozoonosis/tratamiento farmacológico , Humanos , Inmunosupresores/efectos adversos , Masculino , Microscopía Electrónica , Persona de Mediana Edad , Radiografía Torácica , Resultado del Tratamiento
9.
Trials ; 22(1): 868, 2021 Dec 02.
Artículo en Inglés | MEDLINE | ID: mdl-34857020

RESUMEN

BACKGROUND: The effectiveness of erythropoiesis-stimulating agents, which are the main stay of managing anaemia of chronic kidney disease (CKD), is largely dependent on adequate body iron stores. The iron stores are determined by the levels of serum ferritin concentration and transferrin saturation. These two surrogate markers of iron stores are used to guide iron replacement therapy. Most Aboriginal and/or Torres Islander Australians of the Northern Territory (herein respectfully referred to as First Nations Australians) with end-stage kidney disease have ferritin levels higher than current guideline recommendations for iron therapy. There is no clear evidence to guide safe and effective treatment with iron in these patients. We aim to assess the impact of intravenous iron treatment on all-cause death and hospitalisation with a principal diagnosis of all-cause infection in First Nations patients on haemodialysis with anaemia, high ferritin levels and low transferrin saturation METHODS: In a prospective open-label blinded endpoint randomised controlled trial, a total of 576 participants on maintenance haemodialysis with high ferritin (> 700 µg/L and ≤ 2000 µg/L) and low transferrin saturation (< 40%) from all the 7 renal units across the Northern Territory of Australia will be randomised 1:1 to receive intravenous iron polymaltose 400 mg once monthly (200 mg during 2 consecutive haemodialysis sessions) (Arm A) or no IV iron treatment (standard treatment) (Arm B). Rescue therapy will be administered when the ferritin levels fall below 700 µg/L or when clinically indicated. The primary outcome will be the differences between the two study arms in the risk of hospitalisation with all-cause infection or death. An economic analysis and several secondary and tertiary outcomes analyses will also be performed. DISCUSSION: The INFERR clinical trial will address significant uncertainty on the safety and efficacy of iron therapy in First Nations Australians with CKD with hyperferritinaemia and evidence of iron deficiency. This will hopefully lead to the development of evidence-based guidelines. It will also provide the opportunity to explore the causes of hyperferritinaemia in First Nations Australians from the Northern Territory. TRIAL REGISTRATION: This trial is registered with The Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12620000705987 . Registered 29 June 2020.


Asunto(s)
Pueblos Indígenas , Deficiencias de Hierro , Australia , Compuestos Férricos , Ferritinas , Humanos , Hierro , Deficiencias de Hierro/etnología , Deficiencias de Hierro/terapia , Estudios Prospectivos , Ensayos Clínicos Controlados Aleatorios como Asunto , Diálisis Renal
10.
BMC Public Health ; 10: 80, 2010 Feb 19.
Artículo en Inglés | MEDLINE | ID: mdl-20167129

RESUMEN

BACKGROUND: There is an overwhelming burden of cardiovascular disease, type 2 diabetes and chronic kidney disease among Indigenous Australians. In this high risk population, it is vital that we are able to measure accurately kidney function. Glomerular filtration rate is the best overall marker of kidney function. However, differences in body build and body composition between Indigenous and non-Indigenous Australians suggest that creatinine-based estimates of glomerular filtration rate derived for European populations may not be appropriate for Indigenous Australians. The burden of kidney disease is borne disproportionately by Indigenous Australians in central and northern Australia, and there is significant heterogeneity in body build and composition within and amongst these groups. This heterogeneity might differentially affect the accuracy of estimation of glomerular filtration rate between different Indigenous groups. By assessing kidney function in Indigenous Australians from Northern Queensland, Northern Territory and Western Australia, we aim to determine a validated and practical measure of glomerular filtration rate suitable for use in all Indigenous Australians. METHODS/DESIGN: A cross-sectional study of Indigenous Australian adults (target n = 600, 50% male) across 4 sites: Top End, Northern Territory; Central Australia; Far North Queensland and Western Australia. The reference measure of glomerular filtration rate was the plasma disappearance rate of iohexol over 4 hours. We will compare the accuracy of the following glomerular filtration rate measures with the reference measure: Modification of Diet in Renal Disease 4-variable formula, Chronic Kidney Disease Epidemiology Collaboration equation, Cockcroft-Gault formula and cystatin C- derived estimates. Detailed assessment of body build and composition was performed using anthropometric measurements, skinfold thicknesses, bioelectrical impedance and a sub-study used dual-energy X-ray absorptiometry. A questionnaire was performed for socio-economic status and medical history. DISCUSSION: We have successfully managed several operational challenges within this multi-centre complex clinical research project performed across remote North, Western and Central Australia. It seems unlikely that a single correction factor (similar to that for African-Americans) to the equation for estimated glomerular filtration rate will prove appropriate or practical for Indigenous Australians. However, it may be that a modification of the equation in Indigenous Australians would be to include a measure of fat-free mass.


Asunto(s)
Tasa de Filtración Glomerular , Servicios de Salud del Indígena/normas , Enfermedades Renales/diagnóstico , Pruebas de Función Renal/normas , Riñón/fisiología , Nativos de Hawái y Otras Islas del Pacífico/estadística & datos numéricos , Adulto , Australia , Composición Corporal , Tamaño Corporal , Medios de Contraste/farmacocinética , Estudios Transversales , Bases de Datos Factuales , Femenino , Humanos , Yohexol/farmacocinética , Pruebas de Función Renal/métodos , Masculino , Valor Predictivo de las Pruebas , Medición de Riesgo
11.
Clin J Am Soc Nephrol ; 11(6): 993-1004, 2016 06 06.
Artículo en Inglés | MEDLINE | ID: mdl-27076636

RESUMEN

BACKGROUND AND OBJECTIVES: Indigenous Australians experience a heavy burden of CKD. To address this burden, the eGFR Follow-Up Study recruited and followed an Indigenous Australian cohort from regions of Australia with the greatest ESRD burden. We sought to better understand factors contributing to the progression of kidney disease. Specific objectives were to assess rates of progression of eGFR in Indigenous Australians with and without CKD and identify factors associated with a decline in eGFR. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: This observational longitudinal study of Indigenous Australian adults was conducted in >20 sites. The baseline cohort was recruited from community and primary care clinic sites across five strata of health, diabetes status, and kidney function. Participants were then invited to follow up at 2-4 years; if unavailable, vital status, progression to RRT, and serum creatinine were obtained from medical records. Primary outcomes were annual eGFR change and combined renal outcome (first of ≥30% eGFR decline with follow-up eGFR<60 ml/min per 1.73 m(2), progression to RRT, or renal death). RESULTS: Participants (n=550) were followed for a median of 3.0 years. Baseline and follow-up eGFR (geometric mean [95% confidence interval], 83.9 (80.7 to 87.3) and 70.1 (65.9 to 74.5) ml/min per 1.73 m(2), respectively. Overall mean annual eGFR change was -3.1 (-3.6 to -2.5) ml/min per 1.73 m(2). Stratified by baseline eGFR (≥90, 60-89, <60 ml/min per 1.73 m(2)), annual eGFR changes were -3.0 (-3.6 to -2.4), -1.9 (-3.3 to -0.5), and -5.0 (-6.5 to -3.6) ml/min per 1.73 m(2). Across baseline eGFR categories, annual eGFR decline was greatest among adults with baseline albumin-to-creatinine ratio (ACR) >265 mg/g (30 mg/mmol). Baseline determinants of the combined renal outcome (experienced by 66 participants) were higher urine ACR, diabetes, lower measured GFR, and higher C-reactive protein. CONCLUSIONS: The observed eGFR decline was three times higher than described in nonindigenous populations. ACR was confirmed as a powerful predictor for eGFR decline across diverse geographic regions.


Asunto(s)
Progresión de la Enfermedad , Nativos de Hawái y Otras Islas del Pacífico , Insuficiencia Renal Crónica/etnología , Insuficiencia Renal Crónica/fisiopatología , Adulto , Anciano , Albuminuria/orina , Australia/epidemiología , Creatinina/orina , Femenino , Estudios de Seguimiento , Tasa de Filtración Glomerular , Humanos , Estudios Longitudinales , Masculino , Persona de Mediana Edad , Insuficiencia Renal Crónica/terapia , Adulto Joven
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