Chinese Chronic Kidney Disease Patients Research Articles

Prevalence and Risk Factors of Chronic Kidney Disease in Patients With Type 2 Diabetes in China: Cross-Sectional Study.

Chronic kidney disease (CKD) is a significant long-term complication of diabetes and is a primary contributor to end-stage kidney disease. This study aimed to report comprehensive nationwide data on the prevalence, screening, and awareness rates of CKD in Chinese patients with type 2 diabetes, along with associated risk factors. Baseline data analysis of the ongoing prospective, observational IMPROVE study was conducted. The study cohort comprised patients who had been diagnosed with type 2 diabetes more than 12 months prior, received at least 1 hypoglycemic medication, and were aged ≥18 years. The participants completed questionnaires and underwent laboratory assessments, including blood and urine samples. The data encompassed patient demographics, medical history, concurrent medications, and comorbidities. Comprehensive evaluations involved physical examinations, urinary albumin-to-creatinine ratio (UACR), estimated glomerular filtration rate (eGFR), glycated hemoglobin (HbA1c), fasting blood glucose, 2-hour postprandial blood glucose, fasting blood lipid profile, and urinalysis. Descriptive statistics were applied for data interpretation, and logistic regression analyses were used to identify the CKD-associated risk factors in patients with type 2 diabetes. A national study from December 2021 to September 2022 enlisted 9672 participants with type 2 diabetes from 45 hospitals that had endocrinology departments. The enrollees were from diverse regions in China, as follows: central (n=1221), east (n=3269), south (n=1474), north (n=2219), and west (n=1489). The prevalence, screening, and awareness rates of CKD among patients with type 2 diabetes were 31% (2997/9672), 27% (810/2997), and 54.8% (5295/9672), respectively. Multivariate binary regression analysis revealed that the CKD risk factors were screening, awareness, smoking, age, diabetes duration, concurrent antihypertensive and microcirculation medications, diabetic complications (foot, retinopathy, and neuropathy), hypertension, elevated low-density lipoprotein (LDL) cholesterol, and suboptimal glycemic control. Subgroup analysis highlighted an increased CKD prevalence among older individuals, those with prolonged diabetes durations, and residents of fourth-tier cities. Residents of urban areas that had robust educational and economic development exhibited relatively high awareness and screening rates. Notably, 24.2% (1717/7107) of patients with an eGFR ≥90 mL/min/1.73 m2 had proteinuria, whereas 3.4% (234/6909) who had a UACR <30 mg/g presented with an eGFR <60 mL/min/1.73 m2. Compared with patients who were cognizant of CKD, those who were unaware of CKD had increased rates of HbA1c ≥7%, total cholesterol >5.18 μmol/L, LDL cholesterol >3.37 μmol/L, BMI ≥30 kg/m2, and hypertension. In a Chinese population of adults with type 2 diabetes, the CKD prevalence was notable, at 31%, coupled with low screening and awareness rates. Multiple risk factors for CKD have been identified. ClinicalTrials.gov NCT05047471; https://clinicaltrials.gov/study/NCT05047471.

Effectiveness and safety of finerenone in Chinese CKD patients without diabetes: a retrospective, real-world study

BackgroundFinerenone, a non-steroidal mineralocorticoid receptor antagonist, has previously demonstrated its efficacy and safety in chronic kidney disease (CKD) associated with diabetes mellitus. Given its therapeutic potential, finerenone has been preliminarily explored in clinical practice for non-diabetic CKD patients. The effectiveness and safety in this population require further investigation in a real-world setting.MethodsThis retrospective, real-world analysis included non-diabetic CKD patients receiving finerenone. The main clinical outcomes assessed were changes in urinary albumin-to-creatinine ratio (UACR) and estimated glomerular filtration rate (eGFR). Serum potassium (sK+) levels were also monitored. Data were collected at baseline, and then at 1 month and 3 months following treatment initiation.ResultsTotally, 16 patients were included. There was a notable decrease in UACR from 1-month post-treatment, with a further reduction at 3 months, resulting in a median reduction of 200.41 mg/g (IQR, 84.04–1057.10 mg/g; P = 0.028; percent change, 44.52% [IQR, 31.79–65.42%]). The average eGFR at baseline was 80.16 ml/min/1.73m2, with no significant change after 1 month (80.72 ml/min/1.73m2, P = 0.594) and a slight numerical increase to 83.45 ml/min/1.73m2 (P = 0.484) after 3 months. During the 3-month follow-up, sK+ levels showed only minor fluctuations, with no significant differences compared to baseline, and remained within the normal range throughout the treatment period. No treatment discontinuation or hospitalization due to hyperkalemia was observed.ConclusionIn non-diabetic CKD patients, finerenone showed good effectiveness and safety within a 3-month follow-up period. This study provides valuable real-world evidence supporting the use of finerenone in non-diabetic CKD and highlights the need for future large-scale prospective research to further validate its efficacy.

#437 A multicenter, single-arm study of roxadustat in Chinese patients with chronic kidney disease-associated anemia receiving peritoneal dialysis

Abstract Background and Aims Anemia increases morbidity and mortality in patients with chronic kidney disease (CKD). Phase 3 studies have demonstrated the efficacy of roxadustat for anemia treatment in patients with CKD undergoing dialysis; however, data from Chinese patients undergoing peritoneal dialysis (PD) are limited. We evaluated the efficacy and safety of roxadustat in Chinese patients with CKD-anemia undergoing PD. Method In this phase 4, single-arm, multicenter study, we planned to enroll at least 150 Chinese patients with CKD-anemia undergoing PD (either erythropoiesis-stimulating agent [ESA]-treated or ESA-naïve at enrollment), including at least 50 patients with type 2 diabetes mellitus (T2DM) and 50 patients without diabetes mellitus (DM). Study visits occurred every 2 weeks until Week 8 and then every 4 weeks. All patients received oral roxadustat treatment three times per week for 24 weeks according to the approved product package insert. The primary efficacy endpoint was the proportion of patients with a mean hemoglobin (Hb) ≥100 g/L at Weeks 20–24. The secondary efficacy endpoints were subgroup analyses (T2DM vs. non-DM). The exploratory endpoints were the dose required to maintain Hb at ≥100 g/L over Weeks 20–24, the proportion of time when Hb was 100–130 g/L, changes in residual renal function (RRF), urea clearance index (Kt/V), and creatinine clearance (Ccr), amongst others. For the safety analyses, adverse events (AEs) were assessed during treatment and at 4 weeks after completion. Results Overall, 195 patients (116 male [59.5%]) with a mean (standard deviation [SD]) age of 46.3 (12.3) years were enrolled from 22 centers, and 172 (88.2%) completed the study (main reasons for discontinuation: withdrawal, 7 [3.6%]; AE, 5 [2.6%]; switched from PD to hemodialysis, 5 [2.6%]). Overall, 189 patients (96.9%) were ESA-treated and 43 (22.1%) had T2DM. The median (interquartile range) dialysis duration was 16.1 (5.2–43.2) months. The mean (SD) baseline Hb was 98.1 (10.7) g/L, and the ferritin level and transferrin saturation were 320.9 (287.5) μg/L and 35.5% (17.0%), respectively. The mean (SD) treatment duration was 154.3 (35.6) days, and the mean (SD) weekly dose was 244.9 (88.7) mg. The intention-to-treat (ITT) set and safety analysis set (SAF) included all 195 patients. In the ITT set, 85.1% (95% confidence interval [CI] 79.8%–90.5%) of patients had Hb ≥100 g/L over Weeks 20–24. According to the subgroup analysis, 89.2% (95% CI 78.5%–99.9%) of T2DM patients and 84.0% (95% CI 77.8%–90.1%) of non-DM patients had Hb ≥100 g/L over Weeks 20–24 (Fig. 1). The mean (SD) weekly dose required to maintain Hb at ≥100 g/L at Weeks 20–24 was 215.9 (100.0) mg, and the proportion of time that Hb was 100–130 g/L was 76.4% (23.2%). There was a slight decrease in RRF and Ccr. Table 1 shows the RRF, Kt/V, and Ccr results. Of the 195 SAF patients, 158 (81.0%) had ≥1 treatment-emergent AE (TEAE), 20 (10.3%) had drug-related TEAEs, 40 (20.5%) had treatment-emergent serious AEs, and 1 (0.5%) had a TEAE that led to death. The top three TEAEs were upper respiratory tract infection (25 [12.8%]), hypokalemia (17 [8.7%]), and hypoalbuminemia (15 [7.7%]). Conclusion Treatment with roxadustat for 24 weeks effectively corrected anemia in Chinese CKD patients undergoing PD and maintained Hb at ≥100 g/L in the majority of patients, irrespective of baseline T2DM. The AEs were consistent with the characteristics of patients with CKD undergoing PD and with the known safety profile of roxadustat.

Applying stacking ensemble method to predict chronic kidney disease progression in Chinese population based on laboratory information system: a retrospective study.

Chronic kidney disease (CKD) is a major public health issue, and accurate prediction of the progression of kidney failure is critical for clinical decision-making and helps improve patient outcomes. As such, we aimed to develop and externally validate a machine-learned model to predict the progression of CKD using common laboratory variables, demographic characteristics, and an electronic health records database. We developed a predictive model using longitudinal clinical data from a single center for Chinese CKD patients. The cohort included 987 patients who were followed up for more than 24 months. Fifty-three laboratory features were considered for inclusion in the model. The primary outcome in our study was an estimated glomerular filtration rate ≤15 mL/min/1.73 m2 or kidney failure. Machine learning algorithms were applied to the modeling dataset (n = 296), and an external dataset (n = 71) was used for model validation. We assessed model discrimination via area under the curve (AUC) values, accuracy, sensitivity, specificity, positive predictive value, negative predictive value, and F1 score. Over a median follow-up period of 3.75 years, 148 patients experienced kidney failure. The optimal model was based on stacking different classifier algorithms with six laboratory features, including 24-h urine protein, potassium, glucose, urea, prealbumin and total protein. The model had considerable predictive power, with AUC values of 0.896 and 0.771 in the validation and external datasets, respectively. This model also accurately predicted the progression of renal function in patients over different follow-up periods after their initial assessment. A prediction model that leverages routinely collected laboratory features in the Chinese population can accurately identify patients with CKD at high risk of progressing to kidney failure. An online version of the model can be easily and quickly applied in clinical management and treatment.

Efficacy and Safety of Ferric Citrate on Hyperphosphatemia among Chinese Patients with Chronic Kidney Disease Undergoing Hemodialysis: A Phase III Multicenter Randomized Open-Label Active-Drug-Controlled Study

Introduction: Hyperphosphatemia in chronic kidney disease (CKD) patients is positively associated with mortality. Ferric citrate is a potent phosphorus binder that lowers serum phosphorus level and improves iron metabolism. We compared its efficacy and safety with active drugs in Chinese CKD patients with hemodialysis. Methods: Chinese patients undergoing hemodialysis were randomized into two treatment groups in a 1:1 ratio, receiving either ferric citrate or sevelamer carbonate, respectively, for 12 weeks. Serum phosphorus levels, calcium concentration, and iron metabolism parameters were evaluated every 2 weeks. Frequency and severity of adverse events were recorded. Results: 217 (90.4%) patients completed the study with balanced demographic and baseline characteristics between two groups. Ferric citrate decreased the serum phosphorus level to 0.59 ± 0.54 mmol/L, comparable to 0.56 ± 0.62 mmol/L by sevelamer carbonate. There was no significant difference between two groups (p > 0.05) in the proportion of patients with serum phosphorus levels reaching the target range, the response rate to the study drug, and the changes of corrected serum calcium concentrations, and intact-PTH levels at the end of treatment. The change of iron metabolism indicators in the ferric citrate group was significantly higher than those in the sevelamer carbonate group. There are 47 (40.5%) patients in the ferric citrate group, and 26 (21.3%) patients in the sevelamer carbonate group experienced drug-related treatment emergent adverse events (TEAEs); most were mild and tolerable. Common drug-related TEAEs were gastrointestinal disorders, including diarrhea (12.9 vs. 2.5%), fecal discoloration (14.7 vs. 0%), and constipation (1.7 vs. 7.4%) in ferric citrate and sevelamer carbonate group. Conclusion: Ferric citrate capsules have good efficacy and safety in the control of hyperphosphatemia in adult patients with CKD undergoing hemodialysis. Efficacy is not inferior to sevelamer carbonate. The TEAEs were mostly mild and tolerated by the patients.

Creatinine-based equations to estimate glomerular filtration rate should be used with caution in patients with neurogenic bladder.

Patients with neurogenic bladder (NGB) are at an increased risk of developing chronic kidney disease (CKD). However, data related to the real performance of the serum creatinine (Cr)-based estimated glomerular filtration rate (eGFR) equation in patients with NGB are limited. This study is to evaluate the performance of new Cr-based Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation without race and the GFR estimation equation for Chinese CKD patients for the estimation of GFR in Chinese patients with NGB. GFR was determined simultaneously by three methods: a) GFR measured by renal dynamic imaging with 99mTc-DTPA (G-GFR), which was used as the reference GFR; b) GFR estimated by the new Cr-based Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation without race (EPI-GFR); and c) GFR estimated by the equation for Chinese CKD patients (C-GFR). Pearson correlation and linear regression were used to compare eGFR and G-GFR. Differences, absolute differences, precision, and accuracy were compared to identify which equation showed better performance in evaluating GFR in patients with NGB. A total of 171 patients with NGB, including 121 men and 50 women from 20 provinces, 4 autonomous regions, and 3municipalities in China, were enrolled in the final analysis, and the average age was 31.3 ± 11.9 years. Both C-GFR and EPI-GFR were moderately correlated with G-GFR and overestimated G-GFR. The difference between EPI-GFR and G-GFR was similar to that between C-GFR and G-GFR (median of 9.97 vs. 9.95 mL/min/1.73m2 for difference, Wilcoxon signed ranks test, Z = -1.704, p = 0.088), but the absolute difference between EPI-GFR and G-GFR was significantly lower than that between C-GFR and G-GFR (median of 22.3 vs. 25.1 mL/min/1.73m2 for absolute difference, Wilcoxon signed ranks test, Z = -4.806, p < 0.001). Both EPI-GFR and C-GFR displayed similar results of 15, 30, and 50% accuracies (χ2-test, p > 0.05), and there were no significant differences between EPI-GFR and C-GFR in misclassification percentages at different G-GFR levels (χ2-test, p > 0.05). Our study indicated that for patients with NGB in China, Cr-based eGFR equations, which include the new CKD-EPI equation without race and the Chinese GFR estimation equation, showed suboptimal performance, and limited their application in GFR estimation. Further studies are needed to investigate whether incorporating additional biomarkers, such as cystatin C, could improve their performance of GFR estimating equations in patients with NGB.

Validation of the EKFC equation for glomerular filtration rate estimation and comparison with the Asian-modified CKD-EPI equation in Chinese chronic kidney disease patients in an external study

Objectives The aim of this study is to determine whether new European Kidney Function Consortium (EKFC) equation is more applicable than Asian-modified CKD-EPI equation in clinical practice, having a higher accuracy in estimating GFR in our external CKD population. Methods We calculated estimated GFREKFC and GFRCKD-EPI independently using the EKFC and Asian-modified CKD-EPI formulas, respectively. The clinical diagnostic performance of the two equations was assessed and compared by median bias, precision, accuracy (P 30) and so on, using 99mTc-DTPA dual plasma sample clearance method as a reference method for GFR measurement (mGFR). The equation that met the following targets was superior: (1) median bias within ± 3 mL/min/1.73 m2; (2) P 30 > 75%; and (3) better precision and 95% limits of agreement in Bland–Altman analysis. Results Totally, 160 CKD patients were recruited in our external cohort. GFREKFC was highly related to mGFR, with a regression equation of GFREKFC=mGFR × 0.87 + 5.27. Compared with the Asian-modified CKD-EPI equation, EKFC equation demonstrated a wider median bias (–1.64 vs. 0.84 mL/min/1.73 m2, p < 0.01) that was within 3 mL/min/1.73 m2 and not clinically meaningful. Furthermore, the precision (12.69 vs. 12.72 mL/min/1.73 m2, p = 0.42), 95% limits of agreement in Bland–Altman analysis (42.4 vs. 44.4 mL/min/1.73 m2) and incorrect reclassification index of the two target equations were almost identical. Although, EKFC equation had a slightly better P 30 (80.0% vs. 74.4%, p = 0.01). Conclusions The overall performance of EKFC equation is acceptable. There is no clinically meaningful difference in the performance of the Asian-modified CKD-EPI and EKFC equations within the limits imposed by the small sample size.

MO391: Association Between Skeletal Muscle and Level of Physical Activity in Patients With Chronic Kidney Disease: A Cross-Sectional Analysis of the Peaking Cohort

Abstract BACKGROUND AND AIMS Favorable skeletal muscles have been associated with higher physical activity (PA) in the general population. However, little is known regarding this relationship in a population of Chinese chronic kidney disease (CKD) patients. The aim of this study is to investigate the relationship between PA and skeletal muscle in Chinese non-dialysis CKD patients. METHOD This was a cross-sectional analysis of the PEAKING cohort—an open cohort aimed to explore the effect of PA on health-related outcomes in the Chinese non-dialysis CKD population from 2017. The PA of patients was assessed by wearing an accelerometer (ActiGraph) for 9 consecutive days. The levels of PA were classified into four categories (no PA, low, moderate and high level of PA) according to the 2008 U.S. Physical Activity Guidelines. The information of skeletal muscles was evaluated by Biospace Inbody 770 within 180 days after the enrollment. Multivariate linear analysis was conducted to investigate the association between PA and skeletal muscle, adjusted for age, sex, CKD stages, smoking and drinking status, drug use and complications. RESULTS A total of 104 non-dialysis CKD patients (median age 49.6 years, 48% female, 49% with CKD stage 3 or above) were enrolled in this study. None of the included CKD patients had no or low-level PA while 42 (40%) patients had moderate and 62 (60%) had high-level PA. Multivariate linear regression showed that there was no significant association between skeletal muscle and level of PA (B = 0.07, 95% CI −0.58, 2.01; P = 0.279). CONCLUSION Higher-level PA was not significantly associated with more skeletal muscle mass. Further work examining the relationship between skeletal muscle and level of PA needs to be done in a larger sample of non-dialysis CKD patients.

Machine Learning for the Prevalence and Severity of Coronary Artery Calcification in Nondialysis Chronic Kidney Disease Patients: A Chinese Large Cohort Study.

Purpose:This study sought to determine whether machine learning (ML) can be used to better identify the risk factors and establish the prediction models for the prevalence and severity of coronary artery calcification (CAC) in nondialysis chronic kidney disease (CKD) patients and compare the performance of distinctive ML models with conventional logistic regression (LR) model.Materials and Methods:In all, 3701 Chinese nondialysis CKD patients undergoing noncontrast cardiac computed tomography (CT) scanning were enrolled from November 2013 to December 2017. CAC score derived from the cardiac CT was calculated with the calcium scoring software and was used to assess and stratify the prevalence and severity of CAC. Four ML models (LR, random forest, support vector machine, and k-nearest neighbor) and the corresponding feature ranks were conducted. The model that incorporated the independent predictors was shown as the receiver-operating characteristic (ROC) curve. Area under the curve (AUC) was used to present the prediction value. ML model performance was compared with the traditional LR model using pairwise comparisons of AUCs.Results:Of the 3701 patients, 943 (25.5%) patients had CAC. Of the 943 patients with CAC, 764 patients (20.6%) and 179 patients (4.8%) had an Agatston CAC score of 1 to 300 and ≥300, respectively. The primary cohort and the independent validation cohort comprised 2957 patients and 744 patients, respectively. For the prevalence of CAC, the AUCs of ML models were from 0.78 to 0.82 in the training data set and the internal validation cohort. For the severity of CAC, the AUCs of the 4 ML models were from 0.67 to 0.70 in the training data set and from 0.53 to 0.70 in the internal validation cohort. For the prevalence of CAC, the AUC was 0.80 (95% confidence interval [CI]: 0.77-0.83) for ML (LR) versus 0.80 (95% CI: 0.77-0.83) for the traditional LR model (P=0.2533). For the severity of CAC, the AUC was 0.70 (95% CI: 0.63-0.77) for ML (LR) versus 0.70 (95% CI: 0.63-0.77) for traditional LR model (P=0.982).Conclusions:This study constructed prediction models for the presence and severity of CAC based on Agatston scores derived from noncontrast cardiac CT scanning in nondialysis CKD patients using ML, and showed ML LR had the best performance.

The Impact of Hyperkalemia on Mortality and Healthcare Resource Utilization Among Patients With Chronic Kidney Disease: A Matched Cohort Study in China.

ObjectivesThis study aimed to estimate the impact of hyperkalemia on 1-year survival and all-cause healthcare resource utilization among patients with chronic kidney disease in China.MethodsAdult new-onset chronic kidney disease patients were identified between 2012 and 2016, among which the hyperkalemia and non-hyperkalemia cohorts were further selected and matched. Survival and all-cause healthcare resource utilization during a 12 month period were compared using Kaplan-Meier curves with log-rank test, Cox proportional hazard model, and Kaplan-Meier sample average method.ResultsAmong 1,003 pairs of patients (mean age 67.2 ± 14.3 years), the 1-year all-cause mortality was 5.39-times higher in the hyperkalemia cohort than the non-hyperkalemia cohort (hazard ratio = 5.39, P < 0.001). The mean costs and number of healthcare services among the hyperkalemia patients were significantly higher (P < 0.05) in each follow-up month. An annual increase cost of ¥38,479 was observed in the hyperkalemia cohort, largely due to the sharp increase in inpatient costs during the first month after hyperkalemia events (¥22,204 vs. 1,032, P < 0.001). Medication costs were the most important cost component for both cohorts [¥26,786 (45%) vs. ¥12,378(60%)]. However, hyperkalemia patients spent more on non-medication treatment [¥13,410(23%) vs. ¥2,335(11%)] including nursing, monitoring, etc. Hyperkalemia patients had more annual inpatient admissions (1.9 vs. 0.7) and length of stays (28.6 vs. 8.7), while the number of outpatient visits (36.8 vs. 36.4) were similar.ConclusionsIn Chinese chronic kidney disease patients, hyperkalemia is associated with substantially increased clinical and economic burdens that are driven by the short period following the hyperkalemia events, which strengthens calls for sufficient supervision and management of serum potassium.

Food Literacy and Its Associated Factors in Non-Dialysis Patients with Chronic Kidney Disease in China: A Cross-Sectional Study.

PurposeNephrology professionals’ understanding of food literacy (FL) and influencing factors is significant for nutrition management, which is key to controlling disease progress among non-dialysis patients with chronic kidney disease (CKD). However, few studies have explored FL in CKD patients. Hence, this study aimed to investigate the level of FL of non-dialysis patients with CKD and to analyze influencing factors in China.Patients and MethodsA total of 203 CKD patients without dialysis were recruited from August to December 2020 to participate in a cross-sectional study. Food literacy was assessed by a modified short food literacy questionnaire for adults. Related influencing factors were measured by the motivation for dietary self-control scale and the satisfaction with dietary behavior scale. Data were also collected regarding patients’ health information-seeking behavior (four items), satisfaction and compliance with dietary advice from healthcare professionals (two items), and demographics and clinical diagnoses.ResultsThe mean age of patients was 44.5 years (range 18 to 75), and 42.5% were male. Most (50.2%) were in stages 1–2 of CKD. The mean FL score of these patients was 38.75±0.38. The multivariable linear regression analysis shows that secondary educational level (β=0.221, p=0.004), motivation for controlling diet (β=0.198, p=0.003), satisfaction with dietary behaviors (β=0.319, p<0.001), and health information-seeking behavior (β=0.146, p=0.019) were significant influencing factors.ConclusionFood literacy of Chinese CKD patients without dialysis should be improved. Patients with higher education levels exhibit more active information-seeking behaviors, have greater satisfaction with dietary behaviors, and their motivation for dietary self-control is more likely to be associated with better FL. Healthcare workers should be aware of factors influencing FL and attempt to integrate assessment of FL into routine food-related education for CKD patients.

The ensemble learning model is not better than the Asian modified CKD-EPI equation for glomerular filtration rate estimation in Chinese CKD patients in the external validation study

ObjectiveTo assess the clinical practicability of the ensemble learning model established by Liu et al. in estimating glomerular filtration rate (GFR) and validate whether it is a better model than the Asian modified Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation in a cohort of Chinese chronic kidney disease (CKD) patients in an external validation study.MethodsAccording to the ensemble learning model and the Asian modified CKD-EPI equation, we calculated estimated GFRensemble and GFRCKD-EPI, separately. Diagnostic performance of the two models was assessed and compared by correlation coefficient, regression equation, Bland–Altman analysis, bias, precision and P30 under the premise of 99mTc-diethylenetriaminepentaacetic acid (99mTc-DTPA) dual plasma sample clearance method as reference method for GFR measurement (mGFR).ResultsA total of 158 Chinese CKD patients were included in our external validation study. The GFRensemble was highly related with mGFR, with the correlation coefficient of 0.94. However, regression equation of GFRensemble = 0.66*mGFR + 23.05, the regression coefficient was far away from one, and the intercept was wide. Compared with the Asian modified CKD-EPI equation, the diagnostic performance of the ensemble learning model also demonstrated a wider 95% limit of agreement in Bland-Altman analysis (52.6 vs 42.4 ml/min/1.73 m2), a poorer bias (8.0 vs 1.0 ml/min/1.73 m2, P = 0.02), an inferior precision (18.4 vs 12.7 ml/min/1.73 m2, P < 0.001) and a lower P30 (58.9% vs 74.1%, P < 0.001).ConclusionsOur study showed that the ensemble learning model cannot replace the Asian modified CKD-EPI equation for the first choice for GFR estimation in overall Chinese CKD patients.

HLA-B*58:01 screening to prevent allopurinol-induced severe cutaneous adverse reactions in Chinese patients with chronic kidney disease.

Human leukocyte antigen (HLA)-B*58:01 allele is a significant risk factor for allopurinol-induced severe cutaneous adverse reactions (SCARs) which is potentially fatal. In some studies, chronic kidney disease (CKD) was also implicated to compound the risk of SCARs. We aim to investigate if pre-treatment HLA-B*58:01 screening can prevent allopurinol-induced SCARs in Chinese patients with CKD and its cost-effectiveness. We prospectively recruited Chinese CKD patients who required allopurinol during 2011-2015 and performed pre-treatment HLA testing (HLA screening group). Patients tested positive for HLA-B*58:01 were refrained from allopurinol while those tested negative were prescribed allopurinol. The incidence of SCARs in the HLA screening group was compared with the historical control in previous 5years and the cost-effectiveness of HLA testing was analyzed. In the historical control (2006-2010), 3605 patients on allopurinol were screened, 22 out of 1027 (2.14%) CKD Chinese patients newly started on allopurinol developed SCARs, including 6 SJS/TEN. In the HLA screening group, 28 out of 192 patients (14.6%) tested HLA-B*58:01 positive were advised to avoid allopurinol; 156 out of 164 HLA-B*58:01-negative patients received allopurinol and none developed SCARs. The incidence rate of SCARs was significantly lower in the HLA screening group compared with controls (0% vs 2.14% respectively, p = 0.037*). The targeted HLA screening approach was associated with lower healthcare costs compared with no HLA screening (US$ 92,430 vs US$ 281,226). Pre-treatment HLA-B*58:01 screening is cost-effective to target on patients with CKD in Chinese to prevent allopurinol-induced SCARs.

Depression and Associated Factors in Chinese Patients With Chronic Kidney Disease Without Dialysis: A Cross-Sectional Study.

Background: Chronic kidney disease (CKD) has been a globally public health problem over the past decades. The maintenance of physical and mental health is of importance for patients nowadays. Notably, depression is prevalent and associated with various adverse events in CKD patients without dialysis. Prior studies have reported that pain, negative illness perception, pain, and low self-esteem are potential risk factors of depression, while few studies have comprehensively investigated the mechanisms among these factors and depression among this population.Purpose: This study aims to investigate the prevalence of depression and further explore the factors associated with depression among CKD patients without dialysis in China.Design and Methods: We conducted a cross-sectional study in patients with diagnosed CKD to investigate the prevalence of depression was by the Beck Depression Inventory-II (BDI-II). The data on pain interference, illness perception, and self-esteem were also collected via self-administered questionnaires. A structural equation model (SEM) was used to examine the factors associated with depression.Main Findings: From June to October 2019, we successfully interviewed 334 CKD patients at the outpatient clinics. Their mean age was 45.6 years (ranging from 19 to 74 years), and 48.5% were male. Most respondents were at early CKD stages (77.5% stage 1–3) and the prevalence of depression was 22.2%. We found a moderate association between illness perception and depression, which was modified by self-esteem. Similar but weaker association was found between pain interference and depression.Conclusion and Recommendations: Negative illness perception, low self-esteem and severe pain interference were associated with depression among Chinese CKD patients without dialysis. Future studies are warranted to investigate the underlying mechanism and formulate the intervention strategies for this high-risk population.

A Novel Creatinine-Based Equation to Estimate Glomerular Filtration Rate in Chinese Population With Chronic Kidney Disease: Implications for DOACs Dosing in Atrial Fibrillation Patients.

Background: Over/under-estimating renal function may increase inappropriate dosing strategy associated adverse outcomes; however, previously reported equations to estimate renal function have limited accuracy in chronic kidney disease (CKD) patients. Consequently, we intended to develop a novel equation to precisely estimate renal function and subsequently guide clinical treatment for CKD patients. Methods: A novel approach, Xiangya-s equation, to estimate renal function for CKD patients was derived by linear regression analysis and validated in 1885 patients with measured glomerular filtration rate (mGFR) < 60 ml/min/1.73 m2 by renal dynamic imaging at three representative hospitals in China, with the performance evaluated by accuracy, bias and precision. In the meanwhile, 2,165 atrial fibrillation (AF) patients who initiated direct oral anticoagulants (DOACs) between December 2015 and December 2018 were identified and renal function was assessed by estimated creatinine clearance (eCrCl). Events per 100 patient-years was calculated. Cox proportional hazards regression was applied to compare the incidence of outcomes of each group. Results: Xiangya-s equation demonstrated higher accuracy, lower bias and improved precision when compared with 12 creatinine-based and 2 CysC-based reported equations to estimate GFR in multi-ethnic Chinese CKD patients. When we applied Xiangya-s equation to patients with AF and CKD prescribed DOACs, wide variability was discovered in eCrCl calculated by the Cockcroft-Gault (CG), Modification of Diet in Renal Disease Study (MDRD), Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI), Xiangya equation which we had developed for generally patients and Xiangya-s equations, which persisted after grouping by different renal function stages. Equation choice affected drug-dosing adjustments, with the formulas agreeing for only 1.19%, 5.52%, 33.22%, 26.32%, and 36.61% of potentially impacted patients for eCrCl cutoffs of <15, <30, 15–49, 30–49, ≥50 ml/min, respectively. Relative to CG equation, accordance in DOACs dosage was 81.08%, 88.54%, 62.25%, and 47.68% for MDRD, CKD-EPI, Xiangya and Xiangya-s equations for patients with CrCl < 50 ml/min (eCrCl cutoffs of <30, 30–49, ≥50 ml/min), respectively. Reclassification of renal function stages by Xiangya-s equation was significantly associated with stroke or systemic embolism, non-major clinically relevant bleeding and any bleeding events. Conclusion: Xiangya-s equation provides more accurate GFR estimates in Chinese CKD patients who need consecutive monitoring of renal function, which may assist clinicians in choosing appropriate drug dosages.

Drug treatment patterns and work productivity in chronic kidney disease patients with anemia in China: Cross sectional analysis of real-world data.

BackgroundWe explored the association of anemia severity in patients with chronic kidney disease (CKD) and anemia treatment with work productivity in China.MethodsCross-sectional survey data from Chinese physicians and their CKD patients were collected in 2015. Physicians recorded demographics, disease characteristics, and treatment. Patients completed the Work Productivity and Activity Impairment questionnaire. Data were stratified by dialysis-dependence, hemoglobin (Hb) level, and anemia treatment.ResultsBased on data from 1,052 patients (704 non-dialysis-dependent [NDD] and 348 dialysis-dependent [DD] patients), prescribed anemia treatment differed significantly across Hb levels (P < 0.001). In NDD patients, anemia treatment also differed significantly by on-treatment Hb level (P < 0.001). In treated NDD patients with Hb < 10 g/dL, Hb 10 to 12 g/dL, and Hb > 12 g/dL, 31%, 59%, and 38% of patients, respectively, were prescribed oral iron, and 34%, 19%, and 0% of patients, respectively, were prescribed oral iron with erythropoiesis-stimulating agents (ESA). NDD patients were less likely to be prescribed any anemia treatment, and ESA specifically, than DD patients. When treated, 67% and 45% of NDD and DD patients, respectively, had Hb ≥ 10 g/dL (P < 0.001). Overall work and activity impairment differed significantly across Hb levels in NDD and DD patients, with the least impairment observed at the highest Hb level.ConclusionApproximately 40% of NDD patients and 60% of DD patients receiving anemia treatment had Hb < 10 g/dL. Compared with mild anemia patients, severe anemia patients were more likely to be treated for anemia and have impaired work productivity. Chinese CKD patients could benefit from improved anemia treatment.

Renal function is associated with plasma trimethylamine-N-oxide, choline, L-carnitine and betaine: a pilot study.

Chronic kidney disease (CKD) is characterized by decreased glomerular filtration rate (GFR) due to a variety of causes. Most patients remain undiagnosed at early stage of CKD and proceed to end stage CKD due to unawareness and lacking of efficient biomarkers. Trimethylamine-N-oxide (TMAO) and its predecessor products: choline, L-carnitine and betaine are associated with reduced renal function. However, whether the combined variation of the four metabolites could contribute in prediction and stratification of impaired glomerular function in Chinese CKD patients is unknown. Our aim is to investigate the associations of plasma TMAO, choline, L-carnitine and betaine with glomerular filtration in CKD patients. A total of 65 CKD patients and 64 healthy controls were enrolled in this study. Fasting plasma metabolites were detected using liquid chromatography-based method. Plasma TMAO, choline, betaine and L-carnitine levels were differentially correlated with eGFR. The four metabolites were independently associated with CKD after adjustment for multiple traditional risk factors. The combination of the four metabolites had good performance at discriminating CKD from healthy controls (AUC = 0.96) as well as discriminating low eGFR from high eGFR in CKD (AUC = 0.96). Combinations of TMAO and its precursors were associated with glomerular function and might be utilized in evaluation of CKD.

Prevalence and influencing factors of vitaminD deficiency in chronic kidney disease: Across-sectional study.

Very few studies have investigated vitamin D deficiency of Chinese chronic kidney disease (CKD) patients. Our main aims were to measure 25(OH)D levels and to explore the possible correlated factors contributing to vitamin D deficiency. 207 patients who came from north China and were not receiving vitamin D supplementation were included in this study from February 2013 to April 2015. We collected blood samples to determine levels of serum creatinine (Scr), blood urea nitrogen (BUN), uric acid (UA), serum phosphate (P) and calcium (Ca), intact parathyroid hormone (iPTH), albumin (ALB), as well as urinary protein within 24 hours (24hUPr). Total 25(OH)D was measured via electrochemiluminescence immunoassay. Vitamin D deficiency should be defined as a 25(OH)D <15ng/mL. Of the 207 patients, only 20.3% had a circulating 25(OH)D level >15ng/mL. The concentrations of 25(OH)D were 11.73±6.75 ng/mL, 10.44±6.03ng/mL, 10.05±5.57 ng/mL, 9.10±5.00 ng/mL, 7.13±3.99 ng/mL (p<0.001) according to estimated glomerular filtration rate (eGFR) (89-60, 59-45, 44-30, 29-15, <15 mL/min/1.73m2). The prevalence of 25(OH)D deficiency was significantly high in each group (70.1%, 70.8%, 76.5%, 81.6%, 91.4%, p<0.001). 25(OH)D concentration decreased with the decline of renal function. The difference of 25(OH)D levels between the 24hUPr ≥ 3.5 g group and the 24hUPr <3.5 g group was statistically significant. Multivariate linear regression analysis showed that 25(OH)D concentration was associated with 24hUPr and serum Ca. The 25(OH)D concentration was lower, and the prevalence of 25(OH)D deficiency was higher in diabetes mellitus (DM) patients compared with patients without DM. This study shows a high prevalence of 25(OH)D deficiency in CKD patients from north China, and the deficiency is dependent on eGFR. Urinary protein and serum Ca might be associated with 25(OH)D concentration. DM patients have lower 25(OH)D concentrations than non-DM patients.

Prognostic value of pulmonary hypertension in pre-dialysis chronic kidney disease patients.

Pulmonary hypertension is common in chronic kidney disease (CKD) patients. However, the prognostic value of pulmonary hypertension in Chinese predialytic CKD patients is rarely reported. We evaluated the relevant factors and prognostic value of pulmonary hypertension in CKD patients. This retrospective cohort study enrolled 1092 predialytic patients from The Third Affiliated Hospital of Sun Yat-Sen University from May 1st, 2011, to December 31st, 2016. Data of interest were retrieved from electronic medical records. Pulmonary hypertension was defined as pulmonary arterial systolic pressure (PASP) ≥ 35mmHg by echocardiology. All participants were followed from the date of the first echocardiography examination. The primary endpoints were all-cause mortality and cardiovascular mortality. The secondary endpoint was end-stage renal disease (ESRD) defined as starting renal replacement therapy. The prevalence of pulmonary hypertension was 15.9% in the study population. For CKD stage 1, 2, 3a, 3b, 4 and 5, the prevalence was 6.0%, 9.6%, 17.2%, 13.3%, 20.7% and 26.6%, respectively. Older age, lower left ventricular ejection fraction, anemia and higher pulse pressure were independently associated with pulmonary hypertension in CKD patients. In multivariate Cox regression analysis, pulmonary hypertension was the independent risk factor for cardiovascular mortality, but not of all-cause mortality and ESRD. Pulmonary hypertension is not rare in early CKD patients. Patients with older age, anemia, higher pulse pressure and compromised heart function were more likely to comorbid pulmonary hypertension. Pulmonary hypertension maybe a sign of worse cardiovascular outcome in CKD patients.

Prognostic of different glomerular filtration rate formulas in patients receiving percutaneous coronary intervention: insights from a multicenter observational cohort

BackgroundThe relationships of renal dysfunction (RD) and chronic kidney disease (CKD) with prognosis have been well established among non-ST elevation acute coronary syndrome (NSTE-ACS) patients who receive percutaneous coronary intervention (PCI), but the efficacy of different estimated glomerular filtration rate (eGFR) formulas for predicting the prognosis is unknown.MethodsThe cohort originated from a retrospective data, which consecutively enrolled 8197 patients. The eGFR was calculated by the Cockcroft-Gault, Modification of Diet in Renal Disease (MDRD), CKD Epidemiology Collaboration-creatinine, CKD Epidemiology Collaboration-Cys-C, CKD Epidemiology Collaboration-Cys-C-creatinine and a modified abbreviated MDRD (c-aGFR) equations in Chinese CKD patients. Patients were excluded if the eGFR could not be obtained by one of the formulas. Patients were categorized as having normal renal function, mild RD, moderate RD, severe RD, or kidney failure to compare prognosis. The primary outcome was the in-hospital net adverse clinical events (NACE). The secondary outcomes were NACE and all-cause death during follow-up.ResultsIn total, 2159 NSTE-ACS patients (age: 64.23 ± 10.25 years; males: 73.7%) were enrolled. 39 (1.8%) patients with in-hospital NACE were observed. During the 3.23 ± 1.55-year follow-up, 1.7% death and 4.2% NACE were observed in 1 year. The percentage of severe RD patients ranged from 15.4 to 39.2% according to different calculation formulas. A high prevalence of in-hospital NACE was observed in the severe RD groups (ranging from 8 to 14.3% for different formulas). Multiple regression analysis showed that a high eGFR is a protect factor against NACE and all-cause death regardless of the formula use. Receiver operating characteristic curves showed similar predictive performance of the c-aGFR when compared to other formulas (in-hospital NACE: AUC = 0.612, follow-up NACE: AUC = 0.622, and follow-up death: AUC = 0.711).ConclusionsSevere RD results in a high prevalence of in-hospital NACE in NSTE-ACS patients after PCI regardless of the formulas use. Different formulas have a similar ability to predict in-hospital and long-term prognosis in NSTE-ACS patients. The c-aGFR formula is the simplest and a more convenient formula for use in practice.