BackgroundThis 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.MethodsThe 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 m2 (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 m2; (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.DiscussionThis 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 registrationThis trial is registered with the Australian New Zealand Clinical Trial Registry ANZCTR12614001183673.
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.
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.
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