Switching patients from a CNI to belatacept may represent a safe approach to immunosuppression and is being further explored in an ongoing phase 3b trial.

Kidney failure is an important outcome for patients, clinicians, researchers, healthcare systems, payers, and regulators. However, no harmonized international consensus definitions of kidney failure and key surrogates of progression to kidney failure exist specifically for clinical trials. The International Society of Nephrology convened an international multistakeholder meeting to develop consensus on this topic. A core group, experienced in design, conduct, and outcome adjudication of clinical trials, developed a database of 64 randomized trials and the 163 included definitions relevant to kidney failure. Using an iterative process, a set of proposed consensus definitions were developed and subsequently vetted by the larger multi-stakeholder group of 83 participants representing 18 different countries. The

Background: Dietary salt has been debated for decades as having a potentially deleterious influence on human health. Objectives: To determine the quality of research and the relationship between dietary salt and markers for progression of kidney disease. Methods: Data sources included 7 electronic databases comprehensively searched for literature published between January 1, 1966, and August 31, 2004, and a manual search of bibliographies of relevant papers, and consultation with experts in the field. Differences between the paired reviewers were reconciled through consensus or by a content expert. Results: Sixteen studies met the inclusion-exclusion criteria and were identified for review; however, the study methodologies were extremely heterogeneous. Conclusions commonly cited in the studies include: variations in salt consumption are directly correlated with albuminuria, and an increase in salt consumption is associated with an acute increase in glomerular filtration rate, while a reduction in salt consumption may slow the rate of renal function loss. Conclusions: The available published information, while highly variable in methods and quality, suggests that variations in dietary salt consumption directly influence albuminuria, with increasing salt intake associated with worsening albuminuria; however, results are inadequate and conflicting on the effects of dietary salt consumption on renal function, especially over a prolonged time. There was no evidence of a detrimental effect of reduced salt intake. On the other hand, there is consistent experimental evidence to link increased salt exposure with kidney tissue injury. On the basis of these data, we believe that dietary salt restriction should be considered in patients with chronic kidney disease.

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Background: The safety and efficacy of antithrombotic regimens may differ between patients with atrial fibrillation who have acute coronary syndromes (ACS), treated medically or with percutaneous coronary intervention (PCI), and those undergoing elective PCI. Methods: Using a 2×2 factorial design, we compared apixaban with vitamin K antagonists and aspirin with placebo in patients with atrial fibrillation who had ACS or were undergoing PCI and were receiving a P2Y 12 inhibitor. We explored bleeding, death and hospitalization, as well as death and ischemic events, by antithrombotic strategy in 3 prespecified subgroups: patients with ACS treated medically, patients with ACS treated with PCI, and those undergoing elective PCI. Results: Of 4614 patients enrolled, 1097 (23.9%) had ACS treated medically, 1714 (37.3%) had ACS treated with PCI, and 1784 (38.8%) had elective PCI. Apixaban compared with vitamin K antagonist reduced International Society on Thrombosis and Haemostasis major or clinically relevant nonmajor bleeding in patients with ACS treated medically (hazard ratio [HR], 0.44 [95% CI, 0.28–0.68]), patients with ACS treated with PCI (HR, 0.68 [95% CI, 0.52–0.89]), and patients undergoing elective PCI (HR, 0.82 [95% CI, 0.64–1.04]; P interaction =0.052) and reduced death or hospitalization in the ACS treated medically (HR, 0.71 [95% CI, 0.54–0.92]), ACS treated with PCI (HR, 0.88 [95% CI, 0.74–1.06]), and elective PCI (HR, 0.87 [95% CI, 0.72–1.04]; P interaction =0.345) groups. Compared with vitamin K antagonists, apixaban resulted in a similar effect on death and ischemic events in the ACS treated medically, ACS treated with PCI, and elective PCI groups ( P interaction =0.356). Aspirin had a higher rate of bleeding than did placebo in patients with ACS treated medically (HR, 1.49 [95% CI, 0.98–2.26]), those with ACS treated with PCI (HR, 2.02 [95% CI, 1.53–2.67]), and those undergoing elective PCI (HR, 1.91 [95% CI, 1.48–2.47]; P interaction =0.479). For the same comparison, there was no difference in outcomes among the 3 groups for the composite of death or hospitalization ( P interaction =0.787) and death and ischemic events ( P interaction =0.710). Conclusions: An antithrombotic regimen consisting of apixaban and a P2Y 12 inhibitor without aspirin provides superior safety and similar efficacy in patients with atrial fibrillation who have ACS, whether managed medically or with PCI, and those undergoing elective PCI compared with regimens that include vitamin K antagonists, aspirin, or both. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02415400.

Background: Several studies have examined the role of cigarette smoking in the development of renal disease in human populations. However, there have been no systematic reviews on the evidence linking smoking with incident renal disease. Methods: We performed an evidence-based evaluation of peer-reviewed research published during 1966–2005, from a search of five databases, including Ovid MEDLINE and EMBASE. Results: Of the 28 studies that were reviewed, 11 were excluded from the final analysis due to poor methodological quality (n = 6), no reported risk estimate for the association between smoking and kidney disease (n = 3), inability to find a Japanese translator (n = 1), and duplicate cohort (n = 1). Seventeen studies were included in the final analysis; seven studies found an overall significant association between smoking and incident chronic kidney disease, and three studies found a significantly increased risk of chronic kidney disease in current smokers that was gender and/or dose related. An increased risk of developing chronic kidney disease among smokers was significantly associated with male gender (relative risk 2.4, 95% confidence interval 1.2–4.5), >20 cigarettes smoked/day (odds ratio 1.51, 95% confidence interval 1.06–2.15, and relative risk 2.3, 95% confidence interval 1.2–4.3), and smoking >40 years (odds ratio 1.45, 95% confidence interval 1.00–2.09). A pooled estimate of the relative risk (meta-analysis) was deemed inappropriate due to the heterogeneity in methodologies utilized by the different studies. Conclusions: This comprehensive review reveals overall evidence for current cigarette smoking as a risk factor for incident chronic kidney disease. Further investigation is needed to more carefully examine the strength of the association between cigarette smoking and incident kidney disease.

This study set out to determine whether there is a center effect on anemia management in hemodialysis patients. The US Renal Data System and Medicare standard analysis files were analyzed. Between-center variation and within-facility correlations in hematocrit values were examined in two separate data sets (years 2000 and 2001) and compared with simulated samples that were composed of random values that assumed no center effect. Mixed-effect models were used to adjust for multiple factors and quantify the within-facility correlation in hematocrit values. Expected hematocrit values were compared in patients who underwent dialysis at poor and superior performing facilities with fixed characteristics including epoetin ␣ dosing. There was a wider center variation in hematocrit for the actual versus simulated data and a coefficient of variation of 4.1% for the former versus 1.7% for the latter, in both years. O ne of the most important advances in dialysis has been the growing emphasis on quality improvement and the establishment of practice guidelines for the care of dialysis patients. The implementation of these guidelines has been monitored closely using clinical performance measures (CPM) that track several intermediate outcomes, including dialysis adequacy, vascular access placement, and anemia (1,2). Despite aggregate improvements in several CPM, there still are significant variations in performance across nations, regions, and networks and among facilities within networks (3). The implication of such variability in outcomes suggests a need for modification of deficient practices in centers that underperform and replication of best practices in facilities that exceed established benchmarks.Center variations in CPM are closely related to the degree to which individuals within the same facility achieve similar results relative to their counterparts at other centers. This withinfacility correlation and the associated between-center variation are referred to as a center effect. The significance of a center effect relates to what it implies about the factors that influence the CPM under examination A detected center effect is the result of center-specific factors that lead to a within-facility correlation in the CPM of interest and is independent of commonly measured inputs that can be altered at the patient level to improve performance for that outcome. The center-specific factors that contribute to the measured center effect often relate to prevailing processes that are particular to each center but may be poorly characterized. Substantial center effects have been reported for dialysis adequacy and vascular access placement, which are distinct from case-mix and patient-specific factors that are known to affect each of these quality indicators (4 -7).It is not known whether there is a center effect related to the anemia management of hemodialysis patients, but it is important to ask this question. A common strategy of providers is to use higher dosages of erythropoietic agents to improve deficiencies in anemia mana...