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  • 1.

    【2hr】Patients’ perspectives on dialysis decision-making and end-of-life care

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    机译 患者对透析决策和临终护理的看法
    摘要：Background: Few studies have explored dialysis patients’ perspectives on dialysis decision-making and end-of-life-care (EoLC) preferences. We surveyed a racially diverse cohort of maintenance dialysis patients in the Cleveland, OH, USA, metropolitan area. Materials and methods: In this cross-sectional study, we administered a 41-item questionnaire to 450 adult chronic dialysis patients. Items assessed patients’ knowledge of their kidney disease as well as their attitudes toward chronic kidney disease (CKD) treatment issues and EoLC issues. Results: The cohort included 67% Blacks, 27% Caucasians, 2.8% Hispanics, and 2.4% others. The response rate was 94% (423/450). Most patients considered it essential to obtain detailed information about their medical condition (80.6%) and prognosis (78.3%). Nearly 19% of respondents regretted their decision to start dialysis. 41% of patients would prefer treatment(s) aimed at relieving pain rather than prolonging life (30.5%), but a majority would want to be resuscitated (55.3%). Only 8.4% reported having a designated healthcare proxy, and 35.7% reported completing a living will. A significant percentage of patients wished to discuss their quality of life (71%), psychosocial and spiritual concerns (50.4%), and end-of-life issues (38%) with their nephrologist. Conclusion: Most dialysis patients wish to have more frequent discussions about their disease, prognosis, and EoLC planning. Findings from this study can inform the design of future interventions.
  • 2.

    【2hr】Treatment of iron deficiency in patients with chronic kidney disease: A prospective observational study of iron isomaltoside (NIMO Scandinavia)

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    机译 慢性肾脏疾病患者铁缺乏症的治疗：异麦芽糖苷铁的前瞻性观察研究（NIMO斯堪的那维亚）
    摘要：Aims: Iron deficiency is common in patients with chronic kidney disease (CKD). Appropriate iron substitution is critical and intravenous iron is an established therapy for these patients. The objective of this study was to assess treatment routine, effectiveness, and safety of iron isomaltoside (Monofer®, Pharmacosmos A/S, Holbaek, Denmark) in CKD patients in clinical practice. Materials and methods: This was a prospective observational study conducted in predialysis CKD patients treated with iron isomaltoside according to the product label and to routine clinical care. Results: The study included 108 patients with predialysis CKD: 22 were in stage 2 – 3, 41 in stage 4, and 45 in stage 5. The mean (standard deviation) age was 67 (15) years, and 55% of patients were male. The majority of patients (65%) received one iron isomaltoside treatment. In patients with a baseline Hb < 10 g/dL, the mean dose of iron isomaltoside in the study was lower than the estimated total iron requirement (567 mg versus 921 mg). A treatment response of Hb ≥ 1 g/dL was achieved in 16/28 (57%) of patients, and the mean post-treatment Hb level was 10.5 g/dL. The probability of retreatment did not correlate with dose, but no dose administered was > 1,000 mg. There were no serious adverse drug reactions. One nonserious adverse drug reaction – injection site discoloration – was reported, and the patient had an uneventful recovery. Conclusion: Iron isomaltoside shows a good effectiveness and safety profile in predialysis CKD patients. However, some patients did not receive adequate iron doses to allow for optimal correction of their iron deficiency anemia.
  • 3.

    【2hr】Rate and risk factors for AKI after CT scans in a cancer cohort

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    机译 癌症队列CT扫描后AKI的发生率和危险因素
    摘要：Aims: The proinflammatory milieu in cancer patients may expose them to increased risk for acute kidney injury (AKI) after IV contrast (CON). The aims of this study were to determine: (1) the rates of AKI after CON and noncontrast (NC) CT scans in cancer inpatients, (2) if rates differed among cancer subtypes, and (3) whether recent chemotherapy, comorbid conditions, or nephrotoxins increase AKI after CON. Materials and methods: Retrospective data was collected on adults who had received a CON or NC CT from January 1, 2012 to December 30, 2014. AKI was defined as a > 1.5× increased baseline creatinine. Data was analyzed using Rao-Scott χ2-test, propensity score matching, and logistic regressions. Results: A total of 7,512 CT scans were performed in 4,456 patients (4,958 NC, 2,554 CON). The rate for AKI with CON was 7.3% and 11.4% (p < 0.001) with NC imaging. The risk of AKI increased with lower baseline eGFR: for eGFR ≤ 29 mL/min/1.73m2, OR = 1.83 (p = 0.0002); for eGFR 30 – 59 mL/min/1.73m2, OR = 1.5 compared to eGFR ≥ 60 mL/min/1.73m2 (p < 0.0001). AKI rates were higher when any chemotherapy was given within 60 days of CT (OR = 1.22, p < 0.02), with congestive heart failure (OR 1.51, p = 0.0006), and history of AKI (OR 3.89, p < 0.0001). In 1:1 propensity score matched samples, the OR for AKI after CON was 0.87 (p = 0.23) compared to NC. Conclusion: In cancer patients, eGFR below 59 mL/min/1.73m2 were associated with increased rate of AKI, independent of contrast exposure. Congestive heart failure and prior AKI were also associated with increased rates of AKI.
  • 4.

    【2hr】Significance of urinary albumin excretion in patients with cast nephropathy

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    机译 铸型肾病患者尿白蛋白排泄的意义
    摘要：Background: This study was performed to determine whether the urinary albumin excretion rate (%UAE) could distinguish myeloma cast nephropathy (MCN) without glomerular amyloid deposition from MCN with glomerular amyloid deposition. Materials and methods: We retrospectively reviewed clinicopathological data on 16 patients with MCN diagnosed by renal biopsy at Toranomon Hospital from 2004 to 2014. Results: A total of 10 patients had pure MCN without glomerular amyloid deposition (group 1), and 6 patients had MCN with glomerular amyloid deposition (group 2). In all 10 patients from group 1, the underlying disease was multiple myeloma (MM), while 4 patients had MM, and 2 patients had lymphoplasmacytic lymphoma/Waldenström macroglobulinemia (LPL/WM) in group 2. Total protein did not show a significant difference between the two groups, but serum albumin was significantly higher in group 1 than group 2 (p = 0.0101). Serum-adjusted calcium did not show a significant difference between the groups, while serum creatinine (Cre) was significantly higher in group 1 than group 2 (p = 0.0343). Although urinary protein excretion did not differ significantly between the groups, the %UAE was significantly lower in group 1 than group 2 (p = 0.00198). In group 2, 3 of the 4 patients with MM died within 15 months of diagnosis, but the 2 patients with LPL/WM are alive after 32 months. In group 1, only 1 patient died (of unknown causes) within 15 months after diagnosis. Conclusion: In patients with MCN, %UAE may be a useful marker for the detection of coexistence of glomerular lesions, such as amyloidosis, which are associated with a poor outcome.
  • 5.

    【2hr】Serum bone markers in ROD patients across the spectrum of decreases in GFR: Activin A increases before all other markers

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    机译 ROD患者的血清骨标志物在GFR下降的整个范围内：激活素A高于所有其他标志物
    摘要：Introduction: Renal osteodystrophy (ROD) develops early in chronic kidney disease (CKD) and progresses with loss of kidney function. While intact parathyroid hormone (PTH), 1,25-dihydroxyvitamin D3 (1,25D), and fibroblast growth factor-23 (FGF-23) levels are usually considered the primary abnormalities in ROD development, the role of serum activin A elevations in CKD and its relationships to ROD have not been explored. The aims of this study were to evaluate serum activin A at different CKD stages, and to establish the relationships between activin A, bone biomarkers, and bone histomorphometric parameters. Materials and methods: 104 patients with CKD stages 2 – 5D underwent bone biopsies. We measured in the serum activin A, BSAP, DKK1, FGF-23, α-Klotho, intact PTH, sclerostin, TRAP-5b, and 1,25D. Biochemical results were compared across CKD stages and with 19 age-matched controls with normal kidney function. Results: Median activin A levels were increased in all stages of CKD compared to controls from 544 pg/mL in CKD 2 (431 – 628) to 1,135 pg/mL in CKD 5D (816 – 1,456), compared to 369 pg/mL in controls (316 – 453, p < 0.01). The increase of activin A in CKD 2 (p = 0.016) occurred before changes in the other measured biomarkers. Activin A correlated with intact PTH and FGF-23 (r = 0.65 and 0.61; p < 0.01) and with histomorphometric parameters of bone turnover (BFR/BS, Acf, ObS/BS and OcS/BS; r = 0.47 – 0.52; p < 0.01). These correlations were comparable to those found with intact PTH and FGF-23. Conclusion: Serum activin A levels increase starting at CKD 2 before elevations in intact PTH and FGF-23. Activin A correlates with bone turnover similar to intact PTH and FGF-23. These findings suggest a role for activin A in early development of ROD.
  • 6.

    【2hr】Ferumoxytol for iron deficiency anemia in patients undergoing hemodialysis. The FACT randomized controlled trial

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    机译 阿魏酸用于血液透析患者的铁缺乏性贫血。 FACT随机对照试验
    摘要：Background: Patients with chronic kidney disease (CKD) undergoing dialysis often require intravenous iron for iron deficiency anemia (IDA). Materials and methods: The Ferumoxytol for Anemia of CKD Trial (FACT), a randomized, multicenter, open-label, phase 4 study, compared the long-term safety and efficacy of ferumoxytol with iron sucrose for the treatment of IDA in patients with CKD undergoing hemodialysis. Patients with IDA and CKD undergoing hemodialysis were randomized 2:1 to ferumoxytol 1.02 g (2 × 510 mg) or iron sucrose 1.0 g (10 × 100 mg) for a 5-week treatment period (TP). Over 11 months, patients underwent additional 5-week TPs whenever IDA (hemoglobin < 11.5 g/dL and transferrin saturation < 30%) was detected. The primary efficacy endpoint was mean change in hemoglobin from baseline to week 5 for each TP. Adverse events were recorded during the study. Results: Overall, 293 patients received ferumoxytol (n = 196) or iron sucrose (n = 97). Ferumoxytol was noninferior to iron sucrose regarding hemoglobin change from baseline to week 5. The mean change in hemoglobin in the ferumoxytol and iron sucrose groups was 0.5 and 0.4 g/dL, respectively, in TP 1 (least-squares mean difference, 0.13; 95% confidence interval, –0.11 to 0.36) and 0.6 and 0.3 g/dL, respectively, in TP 2 (0.30; 0.06 – 0.55). Treatment-related and serious adverse events were similar in both groups; no new safety signals emerged. Conclusion: Long-term administration of ferumoxytol has noninferior efficacy and a similar safety profile to iron sucrose when used to treat IDA in patients with CKD undergoing hemodialysis.
  • 7.

    【2hr】The impact of a remote monitoring system of healthcare resource consumption in patients on automated peritoneal dialysis (APD): A simulation study

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    机译 病人医疗资源消耗远程监控系统对自动腹膜透析（APD）的影响：一项模拟研究
    摘要：Aims: Remote monitoring (RM) can improve management of chronic diseases. We evaluated the impact of RM in automated peritoneal dialysis (APD) in a simulation study. Materials and methods: We simulated 12 patient scenarios with common clinical problems and estimated the likely healthcare resource consumption with and without the availability of RM (RM+ and RM– groups, respectively). Scenarios were evaluated 4 times by randomly allocated nephrologist-nurse teams or nephrologist-alone assessors. Results: The RM+ group was assessed as having significantly lower total healthcare resource consumption compared with the RM– group (36.8 vs. 107.5 total episodes of resource consumption, p = 0.002). The RM+ group showed significantly lower “unplanned hospital visits” (2.3 vs. 11.3, p = 0.005), “emergency room visits” (0.5 vs. 5.3, p = 0.003), “home visits” (0.5 vs. 5.8, p = 0.016), “exchanges over the telephone” (18.5 vs. 57.8, p = 0.002), and “change to hemodialysis” (0.5 vs. 2.5, p = 0.003). Evaluations did not differ between nephrologist-nurse teams vs. nephrologist-alone assessors. Conclusion: RM can be expected to reduce healthcare resource consumption in APD patients.
  • 8.

    【2hr】Individualized anemia management in a dialysis facility – long-term utility as a single-center quality improvement experience

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    机译 透析设备中的个性化贫血管理–作为单中心质量改进经验的长期效用
    摘要：Background: Standard protocol-based approaches to erythropoiesis stimulating agent (ESA) dosing in anemia management of end-stage renal disease (ESRD) fail to address the inter-individual variability in patient’s response to ESA. We conducted a single-center quality improvement project to investigate the long-term performance of a computer-designed dosing system. Materials and methods: The study was a retrospective case-control study with long-term follow-up. All hemodialysis patients who received treatment at University Kidney Center (Louisville, KY, USA) between September 1, 2009, and March 31, 2017, were included. We implemented an individualized ESA dosing algorithm into an electronic health records database software to provide patient-specific ESA dose recommendations to anemia managers at monthly intervals. The primary outcome was the percentage of hemoglobin (Hb) concentrations between 10 and 12 g/dL during the case-control study and 9 and 11 g/dL during follow-up. Secondary outcomes were intra- and inter-individual Hb variability. For the case-control study, we compared outcomes over 12 months before and after implementation of the algorithm. Subjects served as their own controls. We used the last Hb concentration of the month and ESA dose per week. Long-term follow-up examined trends in proportion within the target range, Hb, and ESA dose. Results: Individualized ESA dosing in 56 subjects was associated with a moderate (6.6%) increase of mean Hb maintenance within target over the 12-month observation period (62.7% before vs. 69.3% after, p = 0.063). Intra-individual mean Hb variability decreased (1.1 g/dL before vs. 0.8 g/dL after, p < 0.001), so did inter-individual mean Hb variability (1.2 g/dL before vs. 1.0 g/dL after, p = 0.010). Long-term follow-up in 233 subjects for 42 months demonstrated stability of the achieved Hb despite an increasing ESA resistance in the patient population. Conclusion: Implementation of the individualized ESA dosing algorithm facilitates improvement in Hb maintenance within target, decreases Hb variability and reduces the dose of ESA required to achieve Hb target.
  • 9.

    【2hr】Consequences of delay in screening, monitoring, and treatment of angiomyolipoma and tuberous sclerosis: A case report

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    机译 延缓血管平滑肌脂肪瘤和结节性硬化症的筛查，监测和治疗的后果：一例报告
    摘要：Background: Tuberous sclerosis complex (TSC) is a multisystem disorder that results in tumor growth in various organs. TSC can affect the kidneys in the form of renal angiomyolipomas and cysts that can lead to chronic kidney disease. Case presentation: A 38-year-old woman was referred to Kennedy Krieger Institute for comprehensive TSC management. Before referral, the patient had gone most of her life without a definite diagnosis of TSC despite visually-prominent signs such as forehead plaques, facial angiofibromas, and ungual fibromas. Eventually, complications of the disease led to the patient requiring hemodialysis at age 34 and a complete bilateral nephrectomy at age 36. However, the patient was not diagnosed with TSC until an evaluation at the National Institutes of Health at age 37. After becoming a patient at our clinic, a multidisciplinary approach was taken to provide comprehensive care by including various disciplines such as nephrology, neurology, pulmonology, ophthalmology, dentistry, dermatology, and cardiology. Discussion and conclusion: TSC consensus recommendations aid in diagnosis, monitoring, and treatment of TSC and its associated manifestations, including those involving the kidneys. Our case underscores the importance of early identification of TSC to prevent future complications and promotes use of a multidisciplinary team to provide comprehensive care.
  • 10.

    【2hr】An integrated pathology and ultrasonography-based simulation for training in performing kidney biopsy

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    机译 基于病理学和超声检查的集成模拟，用于进行肾脏活检的训练
    摘要：Background: Medical practice trends and limitations in trainees’ duty hours have diminished the interest and exposure of nephrology fellows to percutaneous kidney biopsy (PKB). We hypothesized that an integrated nephrology-pathology-led simulation may be an effective educational tool. Materials and methods: A 4-hour PKB simulation workshop (KBSW), led by two ultrasonography (US)-trained nephrologists and two nephropathologists, consisted of 6 stations: 1) diagnostic kidney US with live patients, 2) kidney pathology with plasticine models of embedded torso cross-sections, 3) US-based PKB with mannequin (Blue Phantom™), 4) kidney pathology with dissected cadavers, 5) US-based PKB in lightly-embalmed cadavers, and 6) tissue retrieval adequacy examination by microscope. A 10-question survey assessing knowledge acquisition and procedural confidence gain was administered pre- and post-KBSW. Results: 21 participants attended the KBSW and completed the surveys. The overall percentage of correct answers to knowledge questions increased from 55 to 83% (p = 0.016). The number of “extremely confident” answers increased from 0 – 5% to 19 – 28% in all 4 questions (p = 0.02 – 0.04), and the number of “not at all confident” answers significantly decreased from 14 – 62% to 0 – 5% in 3 out of 4 questions (p = 0.0001 – 0.03). Impact of the imparted training on subsequent practice pattern was not assessed. Conclusion: A novel KBSW is an effective educational tool to acquire proficiency in PKB performance and could help regain interest among trainees in performing PKBs.
  • 11.

    【2hr】Long-term treatment with biosimilar epoetin-α (HX575) in hemodialysis patients with renal anemia: real-world effectiveness and safety in the MONITOR-CKD5 study

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    机译 肾贫血的血液透析患者长期使用生物仿制药Epoetin-α（HX575）治疗：MONITOR-CKD5研究的现实有效性和安全性
    摘要：Aims: To assess real-world effectiveness and safety of intravenous (IV) HX575, a biosimilar epoetin-α, in hemodialysis (HD) patients. Materials and methods: This prospective, observational, pharmacoepidemiological study of adult HD patients treated with IV HX575 for renal anemia for up to 24 months was conducted in 114 centers in 10 European countries. Of 2,086 enrolled subjects (safety sample), 2,023 had ≥ 1 follow-up visit (effectiveness sample). Results: Most (59.3%) patients were male, median age was 68 years. At enrollment, most (82.5%) had been treated with an erythropoiesis-stimulating agent, and 73.0% had adequate iron stores. At baseline, mean (± standard deviation) baseline hemoglobin (Hb) was 11.09 (± 1.14) g/dL and HX575 dose 106.5 (± 78.7) international units (IU)/kg/week; at month 24, Hb was 11.25 (± 1.19) g/dL and HX575 dose 113.0 (± 102.5) IU/kg/week. Variations in mean HX575 dose and Hb over the study were not statistically significant. As to safety, 140 patients (6.7%) experienced ≥ 1 adverse event; of these, 19 events (16 patients; 0.8%) were related to HX575 treatment, 148 (108 patients; 5.2%) were reported as serious, including 12 events in 11 patients (0.5%) stated to be related. No cases of anti-epoetin antibodies or pure red cell aplasia were reported. Conclusions: MONITOR-CKD5 confirmed the real-world effectiveness and safety profile of IV biosimilar HX575. HD patients treated for up to 24 months showed stable dosing patterns and Hb outcomes. The safety profile of HX575 is likewise comparable to reference epoetin-α.
  • 12.

    【2hr】Early postoperative measurement of fibroblast growth factor 23 predicts severe acute kidney injury in infants after cardiac surgery

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    机译 术后早期对成纤维细胞生长因子23的测量可预测心脏手术后婴儿的严重急性肾损伤
    摘要：Aims: Acute kidney injury (AKI) occurs in 30 – 40% of children after cardiac surgery (CS) and is associated with poor prognosis. Fibroblast growth factor 23 (FGF23) is a bone-derived hormone with a pivotal role in phosphorus and vitamin D metabolism. We assessed FGF23 as an early marker for severe AKI (sAKI) in infants after CS. Materials and methods: Samples were previously collected in a multicenter observational study from children after CS. Serum FGF23 (n = 41) and urine AKI biomarker levels (n = 35) were assessed 4 – 8 hours after bypass. sAKI was defined as ≥ 100% rise in serum creatinine over baseline. Non-parametric and ROC analyses were used to evaluate the association between FGF23, urine AKI markers, and sAKI in the week after CS. Results: Serum FGF23, urine NGAL, and urine KIM1 were higher in sAKI patients. The AUC-ROC for urine NGAL (0.74, [0.49 – 0.99]), urine KIM1 (0.79, [0.68 – 0.98]), and serum FGF23 (0.74, [0.5 – 0.9]) showed fair prediction of sAKI. Conclusion: Early measurement of FGF23 has predictive ability in infants who develop sAKI after CS with cardiopulmonary bypass.
  • 13.

    【2hr】Mini-review of kidney disease following hematopoietic stem cell transplant

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    机译 造血干细胞移植后肾脏疾病的简短回顾
    摘要：Advancements in hematopoietic cell transplantation (HCT) have broadened indications for its use and resulted in more long-term survivors. Stem cell transplantation is associated with several well-known toxicities, although renal complications are not well defined. Acute and chronic kidney disease remains a common complication following transplantation itself. Incidence and risk factors for the development of chronic kidney disease (CKD) is less well understood. Recent estimates suggest that nearly 15% of subjects undergoing HCT will develop CKD, a complication that can progress to end-stage renal disease (ESRD), disrupts overall quality of life, and reduces overall survival. Several commonly-reported risk factors include acute kidney injury, graft-versus-host disease, and long-term calcineurin inhibitor use. This review highlights the incidence, timeline, etiology, risk factors, and prognosis of kidney disease in the setting of hematopoietic stem cell transplantation. Investigation of the causes of CKD is needed, as are ways to prevent, mitigate, and treat kidney injury. Renal disease importantly reflects prognosis, with dialysis-requiring patients carrying greater than 80% mortality after 3 years. Although CKD following HCT is common, prospective studies are needed to confirm risk factors and better define the underlying mechanisms in order to promote therapies that prevent this complication.

  • 14.

    【2hr】Disaster preparation in kidney transplant recipients: a questionnaire-based cohort study from a large United States transplant center

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    机译 肾脏移植受者的灾难准备：来自大型美国移植中心的基于问卷的队列研究
    摘要：Background: Few quantitative assessments have assessed disaster preparation in kidney transplant patients. This is a survey-based assessment of disaster preparedness of 200 patients at the University of California San Francisco, USA. Materials and methods: Patients answered questionnaires assessing their level of preparedness as well as barriers to preparation. Preparedness was scored based on response to 7 questions. Univariate analyses compared participant characteristics extracted from the medical chart against three tertiles of preparedness: low (scores 0 – 2), medium (scores 3 – 4), and high (scores 5 – 7). California counties were coded and mapped by average preparedness scores. Results: Only 30% of patients were highly prepared for disasters. Participants were prepared with available medication for 2 weeks (78.5%) and least prepared in having a medical ID bracelet (13%). Significant minorities of patients (40% of patients or more) were unprepared with lists of medications, important phone numbers and disaster kits. Preparedness was not associated with demographic and clinical characteristics. Monterey County was the most prepared of the 31 California counties sampled (score of 4.25 out of 7). Conclusion: All patients should be educated regarding disaster preparation. County and medical services should collaborate to address specialized populations in general preparedness planning.
  • 15.

    【2hr】Affected parent sex and severity of autosomal dominant polycystic kidney disease: a retrospective cohort study

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    机译 回顾性队列研究影响了父母的性别和常染色体显性多囊肾的严重程度
    摘要：Objective: Parental inheritance may differentially affect autosomal dominant polycystic kidney disease (ADPKD) severity via genetic imprinting or in utero epigenetic modifications; however, evidence is inconsistent. We conducted a longitudinal retrospective cohort study to assess the association between sex of the affected parent and time to hypertension diagnosis, end-stage renal disease (ESRD), and death in patients with the PKD1 genotype. Materials and methods: 814 individuals who participated in research at the University of Colorado were studied. Kaplan-Meier survival analysis was performed. The predictor was parental sex, and outcomes were diagnosis of hypertension, progression to ESRD, and death. We also examined associations in four strata according to affected parent and participant sex, as previous studies have reported earlier onset of ESRD in males compared to females. Results: The median follow-up for each outcome was as follows: hypertension, 30 (interquartile range (IQR): 18, 37); ESRD, 43 (IQR: 31, 52), death 39 (IQR: 25, 52) years of age. Among affected offspring in the entire cohort, there was no difference in hypertension diagnosis (p = 0.97) or progression to ESRD (p = 0.79) according to affected parent sex; however, participants with an affected mother were more likely to die than participants with an affected father (p < 0.05). In stratified analyses, males were more likely than females to develop hypertension and reach ESRD when the affected parent was the father (p < 0.01) but not when the affected parent was the mother (p ≥ 0.11). Conclusions: Our results are largely in contrast to the hypothesis that severity of ADPKD is worse with maternal inheritance of disease.
  • 16.

    【2hr】Erythropoietic response to oral iron in patients with nondialysis-dependent chronic kidney disease in the FIND-CKD trial

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    机译 FIND-CKD试验中非透析依赖型慢性肾脏病患者对口服铁的促红细胞生成反应
    摘要：Aims: To evaluate erythropoietic response rates to oral iron over time in iron-deficient anemic patients with nondialysis-dependent chronic kidney disease (ND-CKD). Materials and methods: FIND-CKD was a 1-year, randomized, multicenter trial of iron therapy in patients with ND-CKD, anemia, and iron deficiency, without erythropoiesis-stimulating agent (ESA) therapy. Patients with active infection or C-reactive protein > 20 mg/L were excluded. In this post-hoc analysis, response was defined as ≥ 1 g/dL increase in hemoglobin (Hb) from baseline, before initiation of alternative anemia therapy (i.e., ESA, transfusion, or intravenous iron). Results: 308 patients received oral iron (200 mg elemental iron/day). Mean (SD) Hb at baseline was 10.4 (0.7) g/dL. At week 4, Hb data were available from 292 patients without alternative anemia therapy: 63/292 (21.6%) showed a response. Among the 229 nonresponders at week 4, 48.8% showed a cumulative response on ≥ 1 occasion by week 52 (11.1%, 19.9%, 25.9%, and 28.7% had a response at weeks 8, 12, 24, and 52, respectively), and 27.9% had received alternative iron therapy by week 52. Baseline levels of Hb, ferritin, and transferrin saturation were lower in responders than in nonresponders. Neither concomitant medication nor adherence (as assessed by medication count) was substantially different between early responders and nonresponders. Conclusion: Four weeks after starting oral iron therapy, only 21.6% of anemic patients with ND-CKD and iron deficiency showed an Hb increase of at least 1 g/dL. Among early nonresponders, < 30% responded at any subsequent time point. Earlier consideration of alternative therapy could improve anemia management in this population.
  • 17.

    【2hr】Variability in hemoglobin levels in hemodialysis patients in the current era: a retrospective cohort study

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    机译 当前时代血液透析患者血红蛋白水平的变化：一项回顾性队列研究
    摘要：Background: Given regulatory and reimbursement changes in anemia management, we examined hemoglobin variability in a contemporary cohort of maintenance hemodialysis patients. Materials and methods: The study population included > 200,000 hemodialysis patients with Medicare parts A and B as primary payer on October 1, 2012. Based on 25th and 75th percentiles, monthly hemoglobin values were categorized as low, intermediate, or high. Six variability categories were created by patterns during the 6-month observation period. Stable categories were: always-low, always-intermediate, always-high; variable patterns were: varying between low and intermediate, intermediate and high, low and high (most-variable). Cox proportional hazard models were used to assess the association between hemoglobin variability and all-cause mortality or major adverse cardiac events (MACE). Results: The 25th and 75th hemoglobin percentiles were 10.2 and 11.5 g/dL, respectively, in 2012, vs. 11 and 12.5 g/dL in 2004. ESA doses were lower in all categories in 2012 and transfusion rates higher, particularly for always-low patients. Hemoglobin variability decreased modestly: in 2004, 6.0% were always-intermediate, vs. 9.5% in 2012. In 2012, more patients were always-high and fewer were most-variable. Mortality hazard ratios (HRs) were higher for patients with any low hemoglobin: always-low (HR, 95% CI: 2.07, 1.84 – 2.31), varying between low and intermediate (1.37, 1.29 – 1.45), and most-variable (1.23, 1.16 – 1.31); the pattern was similar for MACE. Conclusions: In 2012 vs. 2004, hemoglobin levels decreased, the range of levels narrowed, and variability decreased modestly; transfusions increased. The highest risk of mortality and MACE appeared to occur in patients with persistently low, rather than highly variable, hemoglobin levels.

  • 18.

    【2hr】Healthcare outcomes in undocumented immigrants undergoing two emergency dialysis approaches

    包量

    机译 接受两种紧急透析方法的无证移民的医疗保健结果
    摘要：Background: Current estimates suggest 6,500 undocumented end-stage renal disease (ESRD) patients in the United States are ineligible for scheduled hemodialysis and require emergent dialysis. In order to remain in compliance with Emergency Medicaid, an academic health center altered its emergency dialysis criteria from those emphasizing interdialytic interval to a set emphasizing numerical thresholds. We report the impact of this administrative change on the biochemical parameters, utilization, and adverse outcomes in an undocumented patient cohort. Methods: This retrospective case series examines 19 undocumented ESRD patients during a 6-month transition divided into three 2-month periods (P1, P2, P3). In P1, patients received emergent dialysis based on interdialytic interval and clinical judgment. In P2 (early transition) and P3 (equilibrium), patients were dialyzed according to strict numerical criteria coupled with clinical judgment. Results: Emergent criteria-based dialysis (P2 and P3) was associated with increased potassium, blood urea nitrogen (BUN), and acidosis as compared to P1 (p < 0.05). Overnight hospitalizations were more common in P2 and P3 (p < 0.05). More frequent adverse events were noted in P2 as compared to P1 and P3, with an odds ratio (OR) for the composite endpoint (intubation, bacteremia, myocardial infarction, intensive care unit admission) of 48 (5.9 – 391.2) and 16.5 (2.5 – 108.6), respectively. Per-patient reimbursement-to-cost ratios increased during criteria-based dialysis periods (P1: 1.49, P2: 2.3, P3: 2.49). Discussion: Strict adherence to criteria-based dialysis models increases biochemical abnormalities while improving Medicaid reimbursement for undocumented immigrants. Alternatives to emergent dialysis are required which minimize cost, while maintaining dignity, safety, and quality of life.
  • 19.

    【2hr】Evaluation of the safety and immunogenicity of subcutaneous HX575 epoetin alfa in the treatment of anemia associated with chronic kidney disease in predialysis and dialysis patients

    包量

    机译 皮下注射HX575 Epoetin Alfa在透析前和透析患者中​​治疗与慢性肾脏病相关的贫血的安全性和免疫原性的评估
    摘要：Aim: To assess the safety and immunogenicity of subcutaneous (SC) HX575 (epoetin-α) in dialysis- and nondialysis-dependent adult patients with chronic kidney disease (CKD). Methods: Open-label, single-arm, multicenter study in patients (n = 416) from Germany, Italy, Poland, Romania, Russia, Turkey, and Ukraine. Results: Mean (standard deviation (SD)) age was 52.3 (15.8) years, all patients were Caucasian, and similar proportions were male/female. 250 patients (60.1%) were erythropoiesis-stimulating agent (ESA)-naïve, and 166 (39.9%) were receiving ESA maintenance therapy at study start; mean (SD) on-study treatment duration with HX575 was 43.4 (15.8) weeks and 45.3 (13.7) weeks, respectively. Binding antierythropoietin (EPO) antibodies were detected by radioimmunoprecipitation (RIP) assay in 7 patients (1.7%; incidence 0.019); 5 of these were ESA-naïve at study entry. No patient developed neutralizing antibodies as determined in a cell-based epoetin neutralizing assay. Of the 7 patients with a positive binding anti-EPO RIP assay, 4 tested negative at later time points while continuing HX575 treatment. Three patients had low titers of anti-EPO antibodies at the last study assessment. There were no clinical signs of immunogenicity or hypersensitivity. Conclusions: SC HX575 was effective for correcting and maintaining correction of anemia, and the mean weekly dose remained stable over time.
  • 20.

    【2hr】Interleukin-1 inhibition, chronic kidney disease-mineral and bone disorder, and physical function

    包量

    机译 白介素-1抑制，慢性肾脏疾病-矿物质和骨骼疾病以及身体机能
    摘要：Objective: Epidemiologic studies have suggested a link between chronic systemic inflammation and chronic kidney disease-mineral and bone disorder (CKD-MBD). Additionally, declining renal function is associated with worsening physical and cognitive function, which may potentially be explained by systemic inflammation, CKD-MBD, or both. We hypothesized that inhibiting inflammation with an interleukin-1 (IL-1) trap would improve markers of CKD-MBD as well as physical/cognitive function in patients with moderate-to-severe CKD. Methods: In a two-site, double-blind trial, 39 patients with stage 3 – 4 CKD completed a randomized trial receiving either the IL-1 trap rilonacept (160 mg/week) or placebo for 12 weeks. The following CKD-MBD markers were assessed in serum before and after the intervention: calcium, phosphorus, 25-hydroxyvitamin D, 1,25-dihydroxyvitamin D, 24,25-dihydroxyvitamin D, intact parathyroid hormone (iPTH), and fibroblast growth factor 23 (FGF23). A battery of tests was also administered in a subgroup (n = 23) to assess multiple domains of physical function (endurance, locomotion, dexterity, balance, strength, and fatigue) and cognitive function. Results: Participants were 65 ± 10 years of age, 23% female, and had a mean estimated glomerular filtration rate of 38 ± 13 mL/min/1.73m2. There were no changes in serum calcium, phosphorus, any vitamin D metabolite, iPTH, or FGF23 levels (p ≥ 0.28) with IL-1 inhibition. Similarly, rilonacept did not alter locomotion, dexterity, balance, strength, fatigue, or cognitive function (p ≥ 0.13). However, endurance (400-m walk time) tended to improve in the rilonacept (–31 s) vs. placebo group (–2 s; p = 0.07). Conclusions: In conclusion, 12 weeks of IL-1 inhibition did not improve markers of CKD-MBD or physical function.
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