Background Roxadustat has been shown effective in treating patients with anemia due to chronic kidney disease. However, its long-term effect on clinical outcomes and socioeconomic burden and safety remains unclear. Methods/Design This is a multicenter, prospective, longitudinal observational cohort study assessing if Roxadustat improves prognosis in dialysis patients. Primary outcomes will be major adverse cardiovascular events (MACE), defined as composites of cardiovascular death, myocardial infarction, cerebral infarction, hospitalization because of heart failure; all-cause mortality, and annual economic costs in two years. The data will be collected via Research electronic data capture (REDCap) based database as well as software-based dialysis registry of Sichuan province. The primary outcomes for the ROAD study participants will be compared with those in the dialysis registry cohort. Data at baseline and study follow up will also be compared to assess the association between Roxadustat and long-term clinical outcomes. Discussion The main objective of this study is to the assess long-term association of Roxadustat on MACE, all-cause mortality, socio-economic burden, safety in dialysis patients, which will provide guidance for designing further large randomized controlled trials to investigate this clinic question. Study registration The study has been registered in Chinese Clinical Trials Registry (ROAD, ROxadustat in treating Anemia in Dialysis patients, registration number ChiCTR1900025765) and provincial observational cohort database (Renal disEAse observational CoHort database, REACH, ChiCTR1900024926), registered 07 September 2019, http://www.chictr.org.cn.
BackgroundErythropoietin is an important drug for the treatment of anemia in hemodialysis patients. However, many patients show erythropoietin-hyporesponsiveness. Roxadustat has been shown to be effective in treating patients with anemia due to chronic kidney disease. However, its efficacy and safety in hemodialysis patients with erythropoietin-hyporesponsive anemia remain unclear.MethodsErythropoietin-hyporesponsiveness was defined as erythropoietin dose of more than 450U/kg intravenously or 300U/kg subcutaneously for 16 weeks, with hemoglobin rising rate below 1 g/dL/month or 11.0 g/dL. A cohort of hemodialysis patients with anemia and a low response to erythropoietin from January 2020 to December 2020 were treated with roxadustat for 12 weeks to observe changes in hemoglobin, iron metabolism, blood lipid, and inflammatory indicators and to evaluate the safety and efficacy of roxadustat.ResultsThere were 56 patients with erythropoietin-hyporesponsiveness, and a total of 44 patients (78.6%) completed the 12-week follow-up, including 16 males (36.4%); patient ages were 54.6±14.2 years. The mean initial treatment dose of roxadustat was 104.4±12.4 mg thrice a week. At week 12, 30 subjects (68.2%) met the protocol-defined primary efficacy endpoint. After 12 weeks of treatment, hemoglobin was significantly increased from 7.81±1.36 g/dL to 9.80±1.94 g/dL (P<0.001), serum ferritin, serum total cholesterol and triglyceride were significantly decreased. While white blood cells and neutrophils significantly increased than baseline.ConclusionThis study indicated that roxadustat significantly increases hemoglobin levels, improving iron absorption and utilization, reducing cholesterol and triglyceride levels, with good short-term safety profile in hemodialysis patients with erythropoietin-hyporesponsive anemia.
In order to further improve the performance of scaled silicon-germanium (SiGe) heterojunction bipolar transistor (HBT) and consider the compatibility with mature CMOS process, a novel SiGe HBT is designed by introducing the embedded Si1−yGey stress raiser into the collector. In the proposed HBT structure, the collector region is subjected to additional uniaxial stress, to enhance the characteristic frequency. The effect of embedded Si1−yGey stress raiser on the frequency performance with different Ge mole fractions is simulated and analyzed by employing SILVACO TCAD tools. The simulation results show that the high frequency performance of the device can be significantly improved by applying additional uniaxial stress in the collector. At y = 0.3, the current gain of the device is increased by approximately 6% compared to the case where no stress is applied to the collector region (y = 0). Taking the uniform SiGe base case with the Ge fraction of 0.25 as an example, by adjusting the Ge fraction of the stress raiser, the peak values of f T and f max reach about 507.7 GHz and 730.7 GHz, respectively. Compared with the traditional SiGe HBT without any additional stress in the collector region, f T and f max are respectively increased by 29.1% and 71.5%. When y = 0.1, the proposed device has the best frequency characteristics due to the peak value of the f T×f max product.
In order to improve the electrical and frequency characteristics of SiGe heterojunction bipolar transistors (HBTs), a novel structure of SOI SiGe heterojunction bipolar transistor is designed in this work. Compared with traditional SOI SiGe HBT, the proposed device structure has smaller window widths of emitter and collector areas. Under the act of additional uniaxial stress induced by Si 0.85 Ge 0.15 , all the collector region, base region and emitter region are strained, which is beneficial to improve the performance of SiGe HBTs. Employing the SILVACO TCAD tools, the numerical simulation results show that the maximum current gain β max , the Earley voltage V A are achieved for 1062 and 186 V, respectively, the product of β and V A , i.e., β × V A , is 1.975 × 10 5 V and, the peak cutoff frequency f T is 419 GHz when the Ge component in the base has configured to be a trapezoidal distribution. The proposed SOI SiGe HBT architecture has a 52.9% improvement in cutoff frequency f T compared to the conventional SOI SiGe HBTs.
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