Therapeutic apheresis and dialysis : official peer-reviewed journal of the International Society for Apheresis, the Japanese Society for Apheresis, the Japanese Society for Dialysis Therapy
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Randomized Controlled Trial
Oral roxadustat three times weekly in ESA-naïve and ESA-converted patients with anemia of chronic kidney disease on hemodialysis: Results from two phase 3 studies.
Roxadustat is a hypoxia-inducible factor prolyl hydroxylase inhibitor approved in China for anemia of dialysis-dependent chronic kidney disease (CKD). Japanese hemodialysis patients with anemia of CKD previously naïve to, or converted from, erythropoiesis-stimulating agents (ESAs) were enrolled in two open-label, noncomparative studies of titrated oral roxadustat administered three times weekly. ESA-naïve patients (n = 75) were randomized to roxadustat (initial dose, 50 or 70 mg) for 24 weeks; ESA-converted patients (n = 164) were assigned to roxadustat (initial dose, 70 or 100 mg based on prior ESA dose) for 52 weeks. ⋯ Nasopharyngitis was the most common TEAE. Two deaths, considered unrelated to roxadustat, occurred in the ESA-Converted Study. Roxadustat effectively corrected and maintained Hb, regardless of previous ESA treatment, in Japanese anemic CKD patients on hemodialysis.
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Iron and erythropoietin deficiencies are determinants of anemia in chronic kidney disease. In hemodialysis (HD) patients, intravenous (IV) iron is associated with a greater hemoglobin (Hb) production and better erythropoietin response but may be associated to hypersensitivity reaction. After the 2013 European Medicines Agency report regarding early detection/management of iron allergic reactions, IV iron administration dramatically reduced in Italian Hemodialysis-Limited-Assistance-Centre (HD-CAL) where a physician is present only once a week. ⋯ Six months of FCM IV treatment once a week increased ferritin and Hb compared to sodium ferric gluconate once a week leading to decreased erythropoietin consumption from 24 000 to 15 000 U/patient/week with an erythropoietin annual expense reduction. No blood transfusions, gastrointestinal intolerance or other adverse effects were reported. The FCM IV administration protocol for our HD-CAL patients was safe and no adverse events were reported, resulting in significantly increased ferritin, transferrin saturation, and Hb levels, reduction of erythropoietin requirements, and consequently reduction of erythropoietin expenses.
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The aim of our study is to evaluate the impact of early vs. late initiation of continuous renal replacement therapy (CRRT), defined by clinical information system (CIS) software using an early warning algorithm based on acute kidney injury network (AKIN) stages, on survival outcome of critically ill intensive care unit (ICU) patients with acute kidney injury (AKI). Of 1144 patients (mean [SD] age: 61.3 [17.9] years, 57.7% were males) hospitalized in ICU over a 2-year-period from January 2016 to December 2017, a total of 272 patients who had developed AKI requiring CRRT were included in this retrospective cross-sectional study. Data on patient demographics (age, gender), reason for ICU hospitalization, AKIN stage, Sequential Organ Failure Assessment (SOFA) score, Acute Physiology and Chronic Health Evaluation II (APACHE II) score, indications for CRRT, and time of CRRT initiation with respect to AKIN early warning algorithm were retrieved from hospital records and the CIS software database. ⋯ Pre- and post-CRRT SOFA scores were significantly lower in patients who received CRRT 0-24 h vs. 24-120 h after the AKIN alarm (P = 0.009 and P = 0.004, respectively), while pre-CRRT APACHE II scores were significantly lower in patients who received CRRT before vs. after the AKIN alarm (P = 0.008). In conclusion, our findings indicate the potential role of using AKIN stage-based early warning system in guiding time to start CRRT and improved survival in critically ill patients with AKI, provided that the CRRT was initiated within the early (first 24 h) of the alarming AKIN Stage II-III events. Future well-designed clinical trials addressing early vs. late initiation of CRRT in critical care patients with AKI are needed to find and answer to the ongoing controversy and help clinicians in refining their indications for starting CRRT.
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Randomized Controlled Trial Multicenter Study
Intermittent Oral Dosing of Roxadustat in Peritoneal Dialysis Chronic Kidney Disease Patients with Anemia: A Randomized, Phase 3, Multicenter, Open-Label Study.
Roxadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor developed to treat anemia in chronic kidney disease (CKD) patients. This Phase 3, randomized, open-label, 24-week study investigated the efficacy and safety of roxadustat in Japanese CKD patients with anemia on peritoneal dialysis (PD) who were previously treated or not treated with erythropoiesis stimulating agents (ESAs). Patients not previously receiving ESA (ESA-Naïve group) were randomized to roxadustat at a starting dose of 50 or 70 mg three times weekly; patients previously receiving ESA (ESA-Converted group) switched from ESA to roxadustat 70 or 100 mg three times weekly depending on the prior ESA dose. ⋯ Average Hb levels (weeks 18-24) were 11.05 g/dL (95% CI: 10.67-11.42; ESA-Naïve) and 10.93 g/dL (95% CI: 10.73-11.13; ESA-Converted). Common TEAEs included nasopharyngitis and back pain. Roxadustat was well tolerated and effective in maintaining target Hb levels in CKD patients on PD who were previously treated or not treated with ESA.
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Comparative Study
In Vitro Evaluation of Resistance and Warming Performance of a Small Blood Warmer on a Continuous Renal Replacement Therapy Circuit.
Children on extracorporeal devices are at increased risk of hypothermia and require circuits with lower extracorporeal volume to avoid blood priming. We performed an in vitro study of the enFlow blood warmer to assess its warming performance and impact on circuit resistance at a high blood flow rate. The enFlow was added on the return line of a continuous renal replacement therapy circuit in a closed circuit primed with expired packed red blood cells (40% Hct). ⋯ Combining both warmers achieved a higher post-warmer temperature between 35.1 and 36.5°C. The enFlow can warm blood at high flow rates with minimal extracorporeal volume increase (~5 mL) and improve hypothermia prevention but may have resistance issues at the highest flows. The use of this device could benefit pediatric practice where smaller extracorporeal volumes are needed and patients are at increased risk of hypothermia.