Chinese Hemodialysis Patients Research Articles

Evaluating the Effectiveness of a Generative Pretrained Transformer-Based Dietary Recommendation System in Managing Potassium Intake for Hemodialysis Patients

ObjectiveDespite adequate dialysis, the prevalence of hyperkalemia in Chinese hemodialysis(HD) patients remains elevated. This study aims to evaluate the effectiveness of a dietary recommendation system driven by Generative Pre-trained Transformers (GPTs) in managing potassium levels in HD patients. MethodsWe implemented a bespoke dietary guidance tool utilizing GPTs technology. Patients undergoing HD at our center were enrolled for the study from October 2023 to November 2023. The intervention comprised two distinct phases. Initially, patients were provided with conventional dietary education focused on potassium management in HD. Subsequently, in the second phase, they were introduced to a novel GPT-based dietary guidance tool. This AI-powered tool offered real-time insights into the potassium content of various foods and personalized dietary suggestions. The effectiveness of the AI tool was evaluated by assessing the precision of its dietary recommendations. Additionally, we compared pre-dialysis serum potassium levels and the proportion of patients with hyperkalemia among patients before and after the implementation of the GPT-based dietary guidance system. ResultsIn our analysis of 324 food photographs uploaded by 88 HD patients, the GPTs system evaluated potassium content with an overall accuracy of 65%. Notably, the accuracy was higher for high-potassium foods at 85%, while it stood at 48% for low-potassium foods. Furthermore, the study examined the effect of GPTs-based dietary advice on patients' serum potassium levels, revealing a significant reduction in those adhering to GPTs recommendations compared to recipients of traditional dietary guidance (4.57±0.76 mmol/L vs. 4.84±0.94 mmol/L, p = 0.004). Importantly, Compared to traditional dietary education, dietary education based on the GPTs tool reduced the proportion of hyperkalemia in HD patients from 39.8% to 25%(p=0.036). ConclusionThese results underscore the promising role of AI in improving dietary management for HD patients. Nonetheless, the study also points out the need for enhanced accuracy in identifying low potassium foods. It paves the way for future research, suggesting the incorporation of extensive nutritional databases and the assessment of long-term outcomes. This could potentially lead to more refined and effective dietary management strategies in HD care.

Retracted: Cognitive Function and Vitamin D Status in the Chinese Hemodialysis Patients

Retracted: Cognitive Function and Vitamin D Status in the Chinese Hemodialysis Patients

Abdominal obesity in Chinese patients undergoing hemodialysis and its association with all-cause mortality.

Obesity in patients undergoing hemodialysis is common. However, there is limited information on the relationship between obesity types defined by the combined body mass index (BMI) and waist circumference (WC) classification criteria and all-cause mortality in Chinese hemodialysis patients. Our objective was to determine the association between obesity types and all-cause mortality in hemodialysis patients. We conducted a prospective cohort study including patients from 11 hemodialysis centers in Beijing. According to the World Health Organization's standards, patients were classified into 2 categories with WC and 4 categories with BMI and then followed up for 1 year. Kaplan-Meier survival analysis was used to compare the difference in the cumulative survival rate in different BMI and WC groups. A multivariate Cox regression analysis was used to determine the association between different types of obesity and all-cause mortality. A total of 613 patients were enrolled, the mean age was 63.8 ± 7.1 years old, and 42.1% were women. Based on the baseline BMI, there were 303 (49.4%) patients with normal weight, 227 (37.0%) with overweight, 37(6.0%) with obesity, and 46 (7.5%) with underweight. Based on the baseline WC, 346 (56.4%) patients had abdominal obesity. During a median follow-up of 52 weeks, 69 deaths occurred. Kaplan-Meier plots demonstrated a significant association of BMI categories (log-rank χ2 = 18.574, p<0.001) and WC categories (log-rank χ2 = 5.698, p=0.017) with all-cause death. With normal BMI and non-abdominal obesity as a reference, multivariate Cox regression analysis results showed that obesity (HR 5.36, 95% CI, 2.09-13.76, p<0.001), underweight (HR, 5.29, 95% CI, 2.32-12.07, p<0.001), normal weight combined with abdominal obesity (HR 2.61, 95% CI, 1.20-5.66, p=0.016), and overweight combined with abdominal obesity (HR 1.79, 95% CI, 1.03-3.73, p=0.031, respectively) were significantly associated with higher risks of all-cause mortality. Our study indicated that abdominal obesity is common and associated with all-cause mortality among Chinese hemodialysis patients.

Corrigendum: Efficacy and safety of darbepoetin alfa injection replacing epoetin alfa injection for the treatment of renal anemia in Chinese hemodialysis patients: A randomized, open‐label, parallel‐group, noninferiority phase III trial

Corrigendum: Efficacy and safety of darbepoetin alfa injection replacing epoetin alfa injection for the treatment of renal anemia in Chinese hemodialysis patients: A randomized, open‐label, parallel‐group, noninferiority phase III trial

Elevated serum FGF21 is an independent predictor for adverse events in hemodialysis patients from two large centers: a prospective cohort study

Introduction We explored the relationship and the predictive value of serum fibroblast growth factor 21 (FGF21) with all-cause mortality, major adverse cardiovascular events (MACEs) and pneumonia in hemodialysis (HD) patients. Methods A total of 388 Chinese HD patients from two HD centers were finally enrolled in this prospective cohort study (registration number: ChiCTR 1900028249) between January 2018 and December 2018. Serum FGF21 was detected. Patients were followed up with a median period of 47 months to record the MACEs and pneumonia until death or 31 December 2022. Results The incidence of all-cause mortality, MACEs and pneumonia in HD patients were 20.6%, 29.6%, and 34.8%, respectively. The optimal cutoffs for FGF21 to predict all-cause mortality, MACEs and pneumonia were 437.57 pg/mL, 216.99 pg/mL and 112.79 pg/mL. Multivariate Cox regression analyses showed that FGF21, as a categorical variable, was an independent predictor for all-cause mortality, MACEs and pneumonia (HR, 3.357, 95% CI, 2.128–5.295, p < 0.001; HR, 1.575, 95% CI, 1.046–2.371, p = 0.029; HR, 1.784; 95% CI, 1.124–2.830; p = 0.014, respectively). The survival nomogram, MACEs-free survival nomogram and pneumonia-free survival nomogram based on FGF21 constructed for individualized assessment of HD patients had a high C-index with 0.841, 0.706 and 0.734. Conclusion Higher serum FGF21 is an independent predictor of all-cause mortality, MACEs and pneumonia in HD patients.

Association between preoperative C-reactive protein to albumin ratio and late arteriovenous fistula dysfunction in hemodialysis patients: a cohort study

Arteriovenous fistula (AVF) dysfunction is a critical complication in hemodialysis (HD) patients, with inflammation potentially contributing to its development. This retrospective cohort study aimed to investigate the association between preoperative C-reactive protein to albumin ratio (CAR) and AVF dysfunction in Chinese HD patients. A total of 726 adults with end-stage renal disease who underwent new AVF placement between 2011 and 2019 were included. Multivariable Cox regression and Fine and Gray competing risk models were employed to assess the relationship between CAR and AVF dysfunction, considering death and renal transplantation as competing risks. Among 726 HD patients, 29.2% experienced AVF dysfunction during a median follow-up of 36 months. Adjusted analyses revealed that higher CAR levels were associated with an increased risk of AVF dysfunction, with a 27% higher risk per one-unit increase in CAR. Furthermore, patients with CAR values ≥ 0.153 exhibited a 75% elevated risk compared to those with CAR values < 0.035 (P = 0.004). The relationship between CAR and AVF dysfunction varied by the site of internal jugular vein catheter placement (P for trend = 0.011). Notably, the Fine and Gray analysis confirmed the association between CAR and AVF dysfunction, with a 31% increased risk per one-unit increase in CAR. The highest CAR tertile remained an independent predictor of AVF dysfunction (HR = 1.77, 95% CI 1.21–2.58, P = 0.003). These findings highlight the potential of CAR as a prognostic marker for AVF dysfunction in Chinese HD patients. Clinicians should consider CAR levels and catheter placement site when assessing the risk of AVF dysfunction in this population.

The relationship between illness perceptions and fluid-control adherence among Chinese hemodialysis patients: a cross-sectional study

ABSTRACT Fluid-control adherence was important for hemodialysis (HD) patients, and while significant correlations between treatment adherence and illness perceptions have been found, there is limited research that explored the relationship between illness perceptions and fluid-control adherence. We sought to assess illness perceptions and fluid-control adherence and to explore the relationship between them among Chinese hemodialysis patients. A cross-sectional study of 253 Chinese HD patients was conducted. We recorded sociodemographic and disease characteristics, Revised Illness Perception Questionnaire (IPQ-R) responses, Fluid Control in Hemodialysis Patients Scale (FCHPS) scores and the interdialytic weight gain (IDWG). The total FCHPS score of hemodialysis patients was of a moderate level, and 45.85% hemodialysis patients’ IDWG exceeded 3.0 kg. Regression analysis revealed that sex, academic level, marital status, treatment control dimension and causal (physical) factors of illness perceptions explained 12.7% variance in the total FCHPS score. Age, normalized whole-body urea clearance (Kt/V), dry weight (DW) residual urine volume (mL/24 h) and consequence dimension of illness perceptions explained 29.0% variance in IDWG. About mediating effect analysis, positive indirect effects on IDWG were found for identity, consequences and emotional representations through the attitude dimension of FCHPS, and negative indirect effects on IDWG were found for treatment control and illness coherence through the attitude dimension of FCHPS. The results demonstrated that some sociodemographic and clinical characteristics and illness perceptions were associated with fluid-control adherence, and the patient’s attitude toward fluid control is an important mediator between illness perceptions and IDWG, implying that attitude can be a focus of intervention programs based on illness perceptions to improve Chinese HD patients’ fluid-control adherence.

Efficacy and Safety of Roxadustat in Chinese Hemodialysis Patients: A Systematic Review and Meta-Analysis

(1) Background: Recently more and more Chinese clinical studies have been conducted to compare the efficacy and safety of roxadustat with erythropoiesis-stimulating agents (ESAs) in hemodialysis (HD) patients. We aimed to assess the efficacy and safety of roxadustat in Chinese HD patients. (2) Methods: The PubMed, Embase, the Cochrane Library, Web of Science, WanFang, China National Knowledge Infrastructure (CNKI), SinoMed, and VIP databases were searched from their inception to July 2022 for randomized controlled trials (RCTs) that compared the efficacy and safety of roxadustat to those of ESAs in treating anemia in Chinese HD patients. (3) Results: Twenty-one RCTs involving 1408 patients were enrolled. Our study showed that the improvement of hemoglobin (Hb) levels and iron metabolism were significantly higher in the roxadustat group than in the ESA group. Additionally, the total adverse events risk was significantly lower in the roxadustat group. (4) Conclusions: In this meta-analysis, we found that roxadustat was more effective and safer than ESAs in treating anemia in Chinese HD patients.

Randomized controlled trial of nalfurafine for refractory pruritus in hemodialysis patients

Background Chronic kidney disease-associated pruritus (CKD-aP) is very common and sometimes refractory to treatment in hemodialysis patients. In a trial conducted in Japan, nalfurafine, effectively reduced itching of treatment-resistant CKD-aP. Our present bridging study aimed to evaluate the efficacy and safety of nalfurafine in Chinese cohort with refractory CKD-aP. Methods In this phase III, multicenter bridging study conducted at 22 sites in China, 141 Chinese cases with refractory CKD-aP were randomly (2:2:1) assigned to receive 5 μg, 2.5 μg of nalfurafine or a placebo orally for 14 days in a double-blind manner. The primary end point was the mean decrease in the mean visual analogue scale (VAS) from baseline. Results A total of 141 patients were included. The primary endpoint analysis based on full analysis set (FAS), the difference of mean VAS decrease between 5 μg nalfurafine and placebo group was 11.37 mm (p = .041); the difference of mean VAS decrease between 2.5 μg and placebo group was 8.81 mm (p = .110). Both differences were greater than 4.13 mm, which met its predefined success criterion of at least 50% efficacy of the key Japanese clinical trial. The per protocol set (PPS) analysis got similar results. The incidence of adverse drug reactions (ADRs) was 49.1% in 5μg, 38.6% in 2.5 μg and 33.3% in placebo group. The most common ADR was insomnia, seen in 21 of the 114 nalfurafine patients. Conclusions Oral nalfurafine effectively reduced itching with few significant ADRs in Chinese hemodialysis patients with refractory pruritus.

Association of dietary fiber with subjective sleep quality in hemodialysis patients: a cross-sectional study in China

Background Poor sleep quality is a common problem among hemodialysis (HD) patients. Dietary fiber is a key component of a healthy diet and is beneficial for a variety of health outcomes; however, evidence of an association between dietary fiber consumption and subjective sleep quality has not been established among HD patients. Therefore, we determined the association between dietary fiber consumption and the subjective sleep quality in Chinese maintenance HD patients, taking into account fiber type and source. Methods Dietary intake was assessed with a validated food frequency questionnaire in a cross-sectional study including 741 maintenance HD patients between December 2021 and January 2022. The daily intake of dietary fiber was categorized into three groups. The lowest tertile was used as the reference category. Sleep quality of patients was accurately calculated using the Pittsburgh sleep quality index standard questionnaire. Multivariable logistic regression model and restricted cubic spline analysis were performed to assess the relationship between dietary fiber consumption and poor sleep quality. Results Compared with the lowest tertile group of dietary fiber intake, the highest tertile group had a lower prevalence of poor sleep quality. After adjustment for potential confounders, a higher intake of total dietary fiber (ORtertile 3 (T3) to tertile 1 (T1)= 0.51, 95% CI: 0.31–0.85), total insoluble dietary fiber (ORT3 to T1 =0.54, 95% CI: 0.33–0.89), and soluble dietary fiber in vegetables (ORT3 to T1 =0.61, 95% CI: 0.40–0.93) were associated with a lower prevalence of poor sleep quality. Furthermore, significant linear trends were also observed (p < 0.05). No significant interactions were observed in subgroup analyses. Conclusion A higher intake of dietary fiber was inversely associated with the poor sleep quality. These findings support the current recommendations that dietary fiber is essential for health and well-being.

Cognitive Function and Vitamin D Status in the Chinese Hemodialysis Patients.

Objective Vitamin D insufficiency and the cognitive function decline are both common in patients receiving hemodialysis (HD). The present study evaluated the relation between cognitive function and circulating vitamin D levels in HD patients in Wannan Medical College Affiliated Yijishan Hospital, China. Methods This study was conducted in 80 patients receiving HD in Wannan Medical College Affiliated Yijishan Hospital. To measure cognitive function, Montreal Cognitive Assessment-Basic (MoCA-B) Chinese Version was used. The 25-hydroxyvitamin D [25(OH)D], which is applied to assess vitamin D status, was tested. One-way ANOVA, Tukey post hoc test, and the correlation and regression analysis were used in this study. Results Based on the MoCA-B, cognitive function decline (the scores below 26) was present in 28 HD patients, accounting for 35% (28/80). The mean age of these patients is 50.5 ± 10.9 years old. The mean level of 25(OH)D was 16.1 ± 7.3 ng/ml in 80 HD patients. In univariate analysis, there was a significant relationship between MoCA-B score and serum 25(OH)D level (p < 0.05). The level of 25(OH)D was positively correlated with MoCA-B score (r = 0.312, p = 0.023), and the association was independent of demographic and clinical features. Conclusions Vitamin D insufficiency may contribute to cognitive function decline in HD patients. Serum level of 25(OH)D is an independent protective factor of cognitive function in the HD patients.

Development and validation of a diagnostic nomogram for sarcopenia in Chinese hemodialysis patients.

Sarcopenia is a clinical condition that is common in patients with chronic kidney disease (CKD), especially in those on dialysis. However, the relatively complicated diagnostic procedure limits its use in clinical situations. In this study we aimed to establish a simplified tool for the diagnosis of sarcopenia in patients on hemodialysis (HD). Overall, 757 eligible patients from seven HD centers in Shanghai and Suzhou, China, were recruited from 2020 to 2021. The cross-sectional data were analyzed. Sarcopenia was diagnosed according to the Asian Working Group for Sarcopenia 2019 criteria. Among them, 511 consecutive patients (77 with and 434 without sarcopenia) from five centers were included in the training set for the establishment of a diagnostic nomogram. Ten investigative parameters including clinical characteristics, body measurements and physical performance were used to derive the diagnostic nomogram. A total of 246 consecutive patients (47 with and 199 without sarcopenia) were included for validation of the diagnostic model. The average age of the enrolled patients was 60.4±12.1years, 59.8% were males and 90.5% received dialysis using an arteriovenous fistula. Overall, the sarcopenia rate was 16.4%. The training and validation sets showed no significant differences in sarcopenia rate (15.1% and 19.1%, respectively; P=.160). The nomogram derived from the training set for sarcopenia, which was based on only four features-age, sex, body weight and grip strength-achieved high C-indexes of 0.929 [95% confidence interval (CI) 0.904-0.953] and 0.955 (95% CI 0.931-0.979) in the training and external sets, respectively, and had a well-fitted calibration curve. The cut-off value was 0.725, with a sensitivity of 0.909 and a specificity of 0.816. The nomogram accurately diagnosed sarcopenia with fewer variables and more simplified diagnostic procedures. The nomogram had a good diagnostic capability for sarcopenia in patients on HD and may be a convenient tool for clinical use.

Hepatitis C Prevalence, Incidence, and Treatment in Chinese Hemodialysis Patients: Results From the Dialysis Outcomes and Practice Patterns Study-China (2019-21).

BackgroundPrior work from the Dialysis Outcomes and Practice Patterns Study (DOPPS) showed HCV prevalence in China in 2012–2015 being in the upper third and HCV incidence the 2nd highest among 15 different countries/regions investigated. The goal of the present investigation was to: (1) determine if HCV prevalence and incidence has changed, and (2) collect detailed data to understand how HCV is treated, monitored, and managed in Chinese HD facilities and non-dialysis chronic kidney disease (CKD) clinics.Data and MethodsDetailed data for 1,700 randomly selected HD patients were reported by 39 randomly selected HD facilities from Beijing, Shanghai, and Guangzhou participating in the DOPPS 7-China study from 2019 to 2021. The study site medical directors completed a survey regarding numerous aspects of HCV treatment and management in HD and ND-CKD patients.ResultsIn this 2019 to 2021 cohort, HCV prevalence was 7.4%, which was lower than the 14.8 and 11.5% HCV prevalence for the 2009–2011 and 2012–2015 cohorts, respectively. HCV incidence of 1.2 cases per 100 pt-yrs also was lower compared to the incidence of 2.1 for the 2012–2015 cohort. Although the great majority of study site medical directors indicated that all or nearly HCV+ patients should be treated for their HCV, very few HCV+ patients have been treated presumably due to substantial cost barriers for affording the new direct acting antivirals (DAAs). The randomly selected facilities in our DOPPS 7-China study appear to have excellent programs in place for frequent monitoring of patients and staff for HCV, education of staff, and referral of HCV cases to external infectious disease, gastroenterology, and liver disease specialists. Liver biopsies were not commonly performed in HCV+ HD patients. HCV genotyping also was rarely performed in participating units.ConclusionsOur study indicates a 50% decline in HCV prevalence and a >40% decline in HCV incidence in Chinese HD patients over the past 10–12 yrs. Chinese HD facilities and associated specialists appear to be well-equipped and organized for successfully treating and managing their HCV+ HD and CKD patients in order to achieve the WHO goal of eliminating HCV by 2030.

Prevalence and Clinical Characteristics of Calciphylaxis in Chinese Hemodialysis Patients.

BackgroundCalciphylaxis is a grievous life-threatening vascular disease that commonly affects dialysis population. This is the first epidemiological survey of calciphylaxis initiated in China.MethodsIn the cross-sectional survey, a stratified sampling method was used to select 24 dialysis centers in Jiangsu Province. The participants were all adult patients in each center who had been on hemodialysis for more than 6 months. Calciphylaxis patients were uniformly diagnosed based on characteristic skin lesions and histopathological features.ResultsA total of 3,867 hemodialysis patients (average age of 55.33 ± 13.89 years; 61.81% of males) were included. Forty eight cases were diagnosed with calciphylaxis, and prevalence was 1.24%. Among calciphylaxis patients, 33 cases were male, and the average age and median dialysis duration were 53.85 ± 15.17 years and 84.00 (48.00, 138.75) months, respectively. Skin biopsy was performed in 70.83% of calciphylaxis patients, and positive rate was 64.71%. Meanwhile, the positive rate of bone scintigraphy in the diagnosis of calciphylaxis was 62.5%. The prevalence of hyperparathyroidism in case group was as high as 72.92% with longer duration, and 42.86% had undergone parathyroidectomy. Multivariate analysis indicated that increased BMI, prolonged dialysis duration, warfarin therapy, hyperparathyroidism, diabetes, tumors, low serum albumin and high serum alkaline phosphatase levels were high-risk factors for calciphylaxis.ConclusionsThe prevalence of calciphylaxis in Chinese hemodialysis patients was 1.24% according to regional epidemiological survey, but its actual prevalence would be presumably far beyond present data. It's urgent to improve clinical understanding of calciphylaxis, and multifaceted diagnostic methods should be applied for early screening.

Status of and Factors Influencing the Stigma of Chinese Young and Middle-Aged Maintenance Hemodialysis Patients: A Preliminary Study.

Many young and middle-aged maintenance hemodialysis patients suffer a poor prognosis, experience a series of problems during long-term treatment and are thus prone to stigma. This study was designed to analyze stigma in young and middle-aged maintenance hemodialysis patients and explore its influencing factors. This study was conducted as a cross-sectional descriptive study with a convenience sampling method and included 97 patients from Shanghai Jiao Tong University Affiliated Sixth People’s Hospital between November 2020 and February 2021. The Social Impact Scale, a demographic questionnaire, and hemodialysis indicators were used in the investigation. Patient biochemical indexes from hemodialysis were compared. Young and middle-aged maintenance hemodialysis patients had a medium level of stigma. Patients who had low income, were younger, were male, had long-term hemodialysis and were unemployed had significantly higher stigma scores than other patients (P < 0.05). Age, gender, occupational status, annual household income and the duration of hemodialysis were found to be the main factors related to stigma in young and middle-aged maintenance hemodialysis patients by multiple regression analysis. Perceptions of hemodialysis-related stigma were common in our sample. Patients who had low income, were younger, were male, had long-term hemodialysis and were employed had a higher level of stigma, which deserves attention from clinical medical workers. Replication studies are needed to confirm these findings.

MO829: Hepatitis C Prevalence, Incidence and Treatment in Chinese Hemodialysis Patients: Results From the Dialysis Outcomes and Practice Patterns Study-China (2019–21)

Abstract BACKGROUND AND AIMS Prior work from the Dialysis Outcomes and Practice Patterns Study (DOPPS) showed the HCV incidence and prevalence in China in 2012–15 to be the second highest and upper third, respectively, among 15 different countries/regions. With direct-acting antivirals (DAA) approved in 2017 in China, we have utilized the DOPPS-China study to: (1) determine if HCV prevalence and incidence in Chinese HD patients has changed after DAAs became available and (2) to understand how HCV is treated, monitored and managed in Chinese HD facilities and non-dialysis chronic kidney disease (CKD) clinics. METHOD Detailed data for 1700 HD patients were collected from 39 randomly selected HD facilities in Beijing, Shanghai and Guangzhou participating in the DOPPS 7-China study (2019–21). Study site medical directors completed a survey regarding HCV treatment and management practices for HD and ND-CKD patients. HCV prevalence was calculated based on an initial cross-section (n = 1279) of study patients, and HCV incidence was based on 1197 patients who were HCV negative at baseline, had ≥2 HCV antibody measurements during follow-up, and were treated in facilities accepting HCV + patients. The median study follow-up was 1.2 years. RESULTS HCV prevalence in this 2019–21 cohort was 7.4% (Table 1), which was &amp;lt;14.8% and 11.5% HCV prevalences reported in DOPPS-China for the 2009–11 and 2012–5 cohorts, respectively (Jadoul et al. 2019). HCV incidence was also lower in the 2019–21 cohort (1.2 cases/100 pt-years) versus that in the 2012–5 cohort (2.1 cases/100 pt-years). Although nearly all study site medical directors indicated that all or nearly all HCV + patients should be treated for HCV (data not shown), medical directors indicated that relatively few HCV + patients have been treated as yet at most dialysis units (Table 2). The DOPPS 7-China study appeared to have excellent programs in place for frequent monitoring of patients and staff for HCV, education of staff and referral of HCV cases in most HD units to infectious disease, gastroenterology and liver disease specialists. Liver biopsies were not commonly performed in HCV + HD patients. HCV genotyping was also rarely performed. Admittedly, data were not collected from the specialist clinics where genotyping may have occurred. CONCLUSION HCV continues to be prevalent among Chinese HD patients despite the prevalence appearing to be lower now than that seen in the 2009–15 DOPPS-China cohorts. However, most HCV + HD patients remain untreated, which may be due to financial/cost reimbursement barriers and patients’ non-acceptance of HCV treatment. If such barriers can be overcome, then Chinese HD facilities and associated specialists, as described here in DOPPS 7, appear to be well-equipped and organized to successfully treating and managing their HCV + HD and CKD patients in order to achieve the WHO goal of eliminating HCV by 2030.

Efficacy and safety of darbepoetin alfa injection replacing epoetin alfa injection for the treatment of renal anemia in Chinese hemodialysis patients: A randomized, open-label, parallel-group, noninferiority phase III trial.

BackgroundThis study was to explore the clinical efficacy and safety of darbepoetin alfa injection replacing epoetin alfa injection (recombinant human erythropoietin injection, rHuEPO) for the treatment of anemia associated with chronic kidney failure in Chinese patients undergoing hemodialysis.MethodThis study was a multicenter, randomized, open‐label, intergroup parallel control phase III noninferiority trial from April 19, 2013 to September 9, 2014 at 25 sites. In this study, the members of the darbepoetin alfa group underwent intravenous administration once per week or once every two weeks. The members of the control drug epoetin alfa group underwent intravenous administration two or three times per week. All subjects underwent epoetin alfa administration during the 8‐week baseline period. After that, subjects were randomly assigned to the darbepoetin alfa group or epoetin alfa group. The noninferiority in the changes of the average Hb concentrations from the baseline to the end of the evaluation period (noninferiority threshold: −1.0 g/dl) was tested between the two treatments. The time‐dependent hemoglobin (Hb) concentration and the maintenance rate of the target Hb concentration (the proportion of subjects with Hb concentrations between 10.0 and 12.0 g/dl) were also evaluated. Iron metabolism, including changes in the serum iron, total iron‐binding capacity, ferritin, transferrin saturation, and comparisons of the dose adjustments between the two groups during the treatment period were analyzed further. Adverse events (AEs) were also observed and compared, and the safety was analyzed between the two treatment groups. The conversion rate switching from epoetin alfa to darbepoetin alfa was also discussed. SAS® software version 9.2 was used to perform all statistical analyses. Descriptive statistics were used for all efficacy, safety, and demographic variable analyses, including for the primary efficacy indicators.ResultsFour hundred and sixty‐six patients were enrolled in this study, and ultimately 384 cases were analyzed for safety, including 267 cases in the darbepoetin alfa group and 117 cases in the epoetin alfa group. There were 211 cases in the per‐protocol set, including 152 cases in the darbepoetin alfa group and 59 cases in the epoetin alfa group. The changes in the average Hb concentrations from the baseline to the end of the evaluation period were −0.07 and −0.15 g/dl in the darbepoetin alfa group and epoetin alfa group respectively. The difference between the two groups was 0.08 g/dl (95% confidence interval [CI]: −0.22 to 0.39), and the lower limit of the 95% CI was −0.22 > −1.0 g/dl. The average Hb concentrations of the two groups were 10.88–11.43 g/dl (darbepoetin alfa) and 10.91–11.38 g/dl (epoetin alfa) during the study period of Weeks 0–28, with the maintenance rates of the target Hb concentration ranging within 71%–87% and 78%–95% in the darbepoetin alfa group and epoetin alfa group respectively. During the period of comparison between the two groups, the incidence of AEs in the darbepoetin alfa group was 61.42%, while in the epoetin alfa group it was 56.41%. All of the adverse events and reactions in the study were those commonly associated with hemodialysis.ConclusionThe overall efficacy and safety of darbepoetin alfa for the treatment of Chinese renal anemia patients undergoing hemodialysis are consistent with those of epoetin alfa.

Darbepoetin alfa injection versus epoetin alfa injection for treating anemia of Chinese hemodialysis patients with chronic kidney failure: A randomized, open-label, parallel-group, non-inferiority Phase III trail.

BackgroundErythropoietin is a glycoprotein that mainly regulates erythropoiesis. In patients with chronic renal failure with anemia, darbepoetin alfa can stimulate erythropoiesis, correct anemia, and maintain hemoglobin levels. This study was designed to demonstrate the efficacy and safety of darbepoetin alfa injections as being not inferior to epoetin alfa injections (Recombinant Human Erythropoietin injection, rHuEPO) when maintaining hemoglobin (Hb) levels within the target range (10.0–12.0 g/dL) for the treatment of renal anemia.MethodsNinety‐five patients were enrolled in this study from April 15, 2013 to April 10, 2014 at 25 sites. In this study, patients (n = 95) aged 18–70 years were randomized into a once per week intravenous darbepoetin alfa group (n = 56) and a twice or three times per week intravenous epoetin alfa group (n = 39) for 28 weeks, who had anemia with hemoglobin levels between 6 g/dL and 10 g/dL due to chronic kidney disease (CKD) and were undergoing hemodialysis or hemofiltration with ESA‐naive (erythropoiesis stimulating agent‐naive). The primary efficacy profile was the mean Hb level (the non‐inferiority margin was −1.0 g/dL, week 21–28); the secondary efficacy profiles were the Hb increase rate (week 0–4), the target Hb achievement cumulative rate and time, the change trends of the Hb levels, and the target Hb maintenance ratio. Adverse events (AEs) were observed and compared, and the efficacy and safety were analyzed between the two treatment groups. Additionally, the frequencies of dose adjustments between the darbepoetin alfa and epoetin alfa groups were compared during the treatment period. SAS® software version 9.2 was used to perform all statistical analyses. Descriptive statistics were used for all efficacy, safety, and demographic variable analyses, including for the primary efficacy indicators.ResultsThe mean Hb level was 11.3 g/dL in the darbepoetin alfa group and 10.7 g/dL in the epoetin alfa group, respectively; the difference of the lower limits of the 95% confidence intervals (CI) between the two groups was 0.1 g/dL (>−1.0 g/dL), and non‐inferiority was proven; the Hb levels started to increase in the first four weeks at a similar increase rate; no obvious differences were observed between the groups in the target Hb achievement cumulative rates, and the Hb levels as well as the target Hb level maintenance rate changed over time. The incidence of AEs was 62.5% in the darbepoetin alfa group and 76.9% in the epoetin alfa group. All the adverse events observed in the study were those commonly associated with hemodialysis.ConclusionDarbepoetin alfa intravenously once per week can effectively increase Hb levels and maintain the target Hb levels well, which makes it not inferior to epoetin alfa intravenously twice or three times per week. Darbepoetin alfa shows an efficacy and safety comparable to epoetin alfa for the treatment of renal anemia.

Echocardiographic left ventricular hypertrophy and geometry in Chinese chronic hemodialysis patients: the prevalence and determinants

BackgroundTo investigate the prevalence of left ventricular hypertrophy (LVH) and explore left ventricular geometry in maintenance hemodialysis (MHD) patients, and to explore the risk factors of LVH which is an important predictor of cardiovascular events.MethodsThe subjects were patients who are on MHD for more than 3 months in Peking University People's Hospital from March 2015 to February 2017. Demographic and clinical data were retrospectively collected. Left ventricular mass was measured by echocardiography. LVH is defined by Left ventricular mass index (LVMI) > 115 g/m2 for men and > 95 g/m2 in women. LVMI and relative wall thickness were used to determine left ventricular geometry. Logistic regression was used to analyze the risk factors of LVH.ResultsAltogether, 131 patients including 77 males were enrolled. The median age was 60 (47, 69) years, with a median dialysis vintage of 48 (18, 104) months. There were 80 patients with LVH, the prevalence rate was 61.1%, and 66.3% of them were moderate to severe LVH. We found that (1) most of the patients were concentric hypertrophy; (2) one-third of the patients were concentric remodeling; (3) only 4 cases with normal geometry. The pre-dialysis serum sodium level and time average pre-dialysis systolic blood pressure (SBP) were independent risk factors of LVH.ConclusionLVH is prevalent in MHD patients. Concentric hypertrophy and concentric remodeling are the most common geometric patterns. Attention should be paid to long-term pre-dialysis SBP management and pre-dialysis sodium control as they might be potentially modifiable risk factors for LVH.

Thrombocytopenia predicts mortality in Chinese hemodialysis patients- an analysis of the China DOPPS

BackgroundHemodialysis (HD) patients have a higher mortality rate compared with general population. Our previous study revealed that platelet counts might be a potential risk factor. The role of platelets in HD patients has rarely been studied. The aim of this study is to examine if there is an association of thrombocytopenia (TP) with elevated risk of all-cause mortality and cardiovascular (CV) death in Chinese HD patients.MethodsData from a prospective cohort study, China Dialysis Outcomes and Practice Patterns Study (DOPPS) 5, were analyzed. Demographic data, comorbidities, platelet counts and other lab data, and death records which extracted from the medical record were analyzed. TP was defined as the platelet count below the lower normal limit (< 100*109/L). Associations between platelet counts and all-cause and CV mortality were evaluated using Cox regression models. Stepwise multivariate logistic regression was used to identify the independent associated factors, and subgroup analyses were also carried out.ResultsOf 1369 patients, 11.2% (154) had TP at enrollment. The all-cause mortality rates were 26.0% vs. 13.3% (p < 0.001) in patients with and without TP. TP was associated with higher all-cause mortality after adjusted for covariates (HR:1.73,95%CI:1.11,2.71), but was not associated with CV death after fully adjusted (HR:1.71,95%CI:0.88,3.33). Multivariate logistic regression showed that urine output < 200 ml/day, cerebrovascular disease, hepatitis (B or C), and white blood cells were independent impact factors (P < 0.05). Subgroup analysis found that the effect of TP on all-cause mortality was more prominent in patients with diabetes or hypertension, who on dialysis thrice a week, with lower ALB (< 4 g/dl) or higher hemoglobin, and patients without congestive heart failure, cerebrovascular disease, or hepatitis (P < 0.05).ConclusionIn Chinese HD patients, TP is associated with higher risk of all-cause mortality, but not cardiovascular mortality. Platelet counts may be a useful prognostic marker for clinical outcomes among HD patients, though additional study is needed.