Roxadustat (FG-4592) treatment for anemia in dialysis-dependent (DD) and not dialysis-dependent (NDD) chronic kidney disease patients: A systematic review and meta-analysis.

The effect of roxadustat (FG-4592) on individuals with chronic kidney diseases (CKD) patients receiving or not receiving the dialysis was unclear. The aim of this study was to evaluate the efficacy of roxadustat for the treatment of anemia in patients who are dialysis dependent (DD) or dialysis independent (NDD) CKD. We performed a systematic review of randomised controlled trials (RCTs) comparing treatment with roxadustat versus placebo or epoetin alfa up to November 2019. We investigated the efficacy of roxadustat in the levels of hemoglobin and other clinical parameters in renal anemia in patients with NDD and DD-CKD. We estimated weighted-mean difference (WMD) using random effect models. We included six RCTs comprising 1001 patients of whom 70.6 % were treated with roxadustat and 294 controls. The control group for studies of NDD-CKD patients was placebo whereas an active control of epoetin-alfa was used in studies of DD-CKD patients. Median follow-up time was 8 weeks. All trials were industry-sponsored. Overall, roxadustat increased hemoglobin levels by 1.20 g/dl (95 % CI:0.66, 1.75,P < 0.0001,I2 = 99.3 %). Hemoglobin levels increased by 1.99 g/dl in NDD-CKD patients versus placebo and 0.52 g/dl in DD-CKD patients versus epoetin-alfa. Roxadustat was associated with a decrease the levels of hepcidin by -49.3 ng/dl (-38.5 ng/dl in NDD patients versus placebo and -27.7 ng/dl in DD patients versus epoetin alfa), a decrease in ferritin of -49.7 µmol/l (-52.2 µmol/l in NDD patients versus placebo and -7.3 µmol/l in DD patients versus epoetin alfa), and increase in total iron-binding capacity of 32.2 µmol/l (14.1 µmol/l in NDD patients versus placebo and 13.6 µmol/l in DD patients versus epoetin alfa). The percentage change in the transferrin saturation levels was -2.07 % (-6%, NDD patients versus placebo, and +3.7 % in DD patients versus epoetin alfa) in anemia associated CKD patients. This review found roxadustast increases the levels of hemoglobin, serum transferrin, intestinal iron absorption, and reduces hepcidin in both NDD and DD-CKD patients. Safety data is still emerging.

Factors related to fatigue in Chinese patients with end-stage renal disease receiving maintenance hemodialysis: a multi-center cross-sectional study.

BACKGROUD: Fatigue is considered as a common symptom in patients with end-stage renal disease (ESRD) and can significantly decrease patients' quality of life. This study aimed to assess fatigue in hemodialysis patients and to investigate risk factors of fatigue in Chinese patients receiving maintenance hemodialysis (MHD) in China. METHODS: Eligible patients completed questionnaires including demographic information, a Chinese version of the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue), the Family APGAR Index (APGAR), the medical outcomes study health status-Social Functioning subscale (SF-36,SocF), and the Pittsburgh sleep quality index (PSQI). Laboratory parameters were abstracted by medical records review. The multiple linear regression model was used to relate parameters with the FACIT-Fatigue score. RESULTS: A total of 345 MHD patients (216 men and 129 women, age 55.6 ± 12.8) were recruited in this study. The score of FACIT-Fatigue was 39 (Interquartile Range, 31-44). Fatigue was correlated with PSQI scores (p < 0.001), SocF scores (p < 0.001), comorbidity (p = 0.006), exercise time <1 hour per day (p = 0.003), adequacy of dialysis (Kt/V) < 1.2 (p = 0.016), APGAR scores (p = 0.014), and high Scr (p = 0.043). CONCLUSIONS: Fatigue is related to sleep disturbance, social and family functioning, taking physical exercise time, comorbidity condition, Kt/V and serum creatinine level in Chinese MHD patients. Future studies and interventions should focus on developing strategies and improving the quality of life in patients by addressing these significant contributing factors.

Educational intervention for metabolic bone disease in patients with chronic kidney disease: a systematic review and meta-analysis.

Metabolic bone disease (MBD) is a common complication of chronic kidney disease (CKD). The currently accepted international guidelines for treatment of CKD-MBD has been published, unfortunately adequate control of serum markers of disorder, especially hyperphosphatemia, is poorly achieved. Whether educational intervention is an effective way for improving CKD-MBD remains controversial. A systematic review of educational intervention versus routine care to improve patients with CKD-MBD was conducted. All randomized controlled trials (RCTs) and quasi-RCTs examining the efficacy of educational intervention to improve patients with CKD-MBD were included. We performed a comprehensive search of several databases and sources to identify eligible trials. In addition, we searched unpublished studies by tracking the SIGLE (System for Information on Grey Literature) database. Finally, 8 RCTs and 2 quasi-RCTs containing 775 participants were included in our systematic review. The result of our study revealed that the educational intervention to patients with CKD-MBD led to an improvement of the serum phosphorus and calcium by phosphate product. Educational intervention is a beneficial supplement method in improving CKD-MBD and putting off deterioration of the disease.

Development and Evaluation of the Psychometric Properties of the CKD-MBD Knowledge and Behavior (CKD-MBD-KB) Questionnaire for Patients With Chronic Kidney Disease.

CONTEXT: Chronic kidney disease-mineral and bone disorder (CKD-MBD) is one of the most complicated morbidities among patients with end-stage renal disease. At present, a specific questionnaire assessing relevant knowledge and behavior for patients with CKD-MBD is still unavailable. OBJECTIVES: To develop and evaluate a valid and reliable questionnaire specific to patients with CKD-MBD. METHODS: Both quantitative and qualitative analyses were combined to develop and estimate the CKD-MBD knowledge and behavior (CKD-MBD-KB) questionnaire. Three hundred thirteen and 295 patients, respectively, participated in the investigation during the period from November 2013∼October 2014. Reliability and validity testing were conducted to analyze the psychometric properties of questionnaire. RESULTS: The final version of the CKD-MBD-KB questionnaire encompasses two domains, five facets, and 50 items. Reliability analysis showed that the Cronbach alpha of the five facets ranged from 0.578 to 0.854. Retest correlation coefficients of the five facets ranged from 0.825 to 0.944. Nine common factors were extracted from exploratory factor analysis that interpreted the cumulative variation of 64.1%, and factor loadings of all items were greater than 0.4. The results of confirmatory factor analysis indicated that the model had a satisfactory goodness of fit; the root mean square error of approximation = 0.070. Meanwhile, a significant correlation was found between each item and its facet. CONCLUSION: This CKD-MBD-KB questionnaire has been confirmed to have adequate psychometric properties (good reliability and validity) and may be useful in the assessment of patient-related knowledge, intervention programs, and treatment protocols.

Psychometric properties of the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) in Chinese patients receiving maintenance dialysis.

CONTEXT: Fatigue is a common symptom reported by patients with end-stage renal disease, and it can significantly decrease patients' quality of life. A brief and convenient fatigue assessment tool is needed for Chinese patients on maintenance dialysis. OBJECTIVES: To determine the psychometric characteristics of the Chinese version of the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) in patients receiving maintenance dialysis. METHODS: The Chinese version of the FACIT-Fatigue was obtained from the FACIT system. Test-retest reliability of this scale was examined using intraclass correlation coefficients, and the internal consistency was calculated by Cronbach's alpha. Content validity was examined using the content validity index (CVI), scale-level CVI/universal agreement, and scale-level CVI/average agreement. Construct validity was tested using Pearson product-moment correlations of the FACIT-Fatigue scores with the Revised Piper Fatigue Scale, Hospital Anxiety and Depression Scale, Pittsburgh Sleep Quality Index, and disease characteristics during the same period. RESULTS: A total of 172 patients (111 males and 61 females, mean age 52.6 ± 12.5 years) completed this study, with a median FACIT-Fatigue score of 41 (first and third quartiles 34.3-46). The Chinese version of the FACIT-Fatigue had excellent test-retest reliability (intraclass correlation coefficient = 0.98) and internal consistency (Cronbach's alpha = 0.92); the validity of the scale was supported by CVI, scale-level CVI/universal agreement, and scale-level CVI/average agreement values of at 0.67-1, 0.85, and 0.96, respectively. The standard error of measurement of the FACIT-Fatigue was 1.2. The significant correlations between the FACIT-Fatigue score and the Revised Piper Fatigue Scale (r = -0.658), Hospital Anxiety and Depression Scale (-0.566), and Pittsburgh Sleep Quality Index (-0.489) were supported by the FACIT-Fatigue, with good construct validity (all P < 0.01). CONCLUSION: The FACIT-Fatigue had acceptable validity and reliability for maintenance dialysis patients and can be used as a valid tool for the measurement of fatigue among these Chinese patients.

Indicators and correlates of psychological disturbance in Chinese patients receiving maintenance hemodialysis: a cross-sectional study.

PURPOSE: Depression and anxiety have been considered as the most common comorbidities in maintenance hemodialysis (MHD) patients. This study aimed to assess mental disorder in hemodialysis patients and to study the indicators and correlates of psychological disturbance among patients receiving MHD in China. METHODS: A cross-sectional study was conducted in 187 outpatients undergoing regular hemodialysis for at least 3 months. All the participants completed the Hospital Anxiety and Depression Scale (HADS), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue, Chinese mainland version), Pittsburgh Sleep Quality Index (PSQI), Family APGAR Index (PAGAR), Family Adaptability and Cohesion Evaluation Scale (FACES II, Chinese version) and the Social Functioning Questionnaire (SFQ). RESULTS: Based on the cutoff point of HADS-D/A ≥ 8, 51 (27.3%) and 29 (15.5%) patients reported depression and anxiety, respectively; 26 (13.9%) of all reported both depression and anxiety. Depressive patients had lower economic status, less subsidies, less than 3 years duration on hemodialysis and comorbidities when compared to patients without depression (all P < 0.05). HADS-D showed positive correlations with HADS-A, PSQI and SFQ and negative correlations with FACIT-Fatigue, PAGAR, family cohesion and adaptability (all P < 0.001). Patients with better family cohesion showed higher level of psychosocial well-being no matter their economic status. Binary logistic regression analysis demonstrated that anxiety (OR 1.80, P < 0.001) and bad social functioning (OR 1.31, P < 0.001) were independently associated with depression. CONCLUSION: More attention should be paid on assessment and management psychological disturbance, and development family/social/medical supporting system for Chinese patients receiving MHD.