The independent association between the indices of iron stores or administered intravenous iron, both of which vary over time, and survival in patients who are on maintenance hemodialysis (MHD) is not clear. It was hypothesized that the observed associations between moderately high levels of three iron markers (serum ferritin, iron, and iron saturation ratio) or administered intravenous iron and all-cause and cardiovascular death is due to the time-varying confounding effect of malnutrition-inflammation-cachexia syndrome (MICS). Time-dependent Cox regression models were examined using prospectively collected data of the 2-yr (July 2001 to June 2003) historical cohort of 58,058 MHD patients from virtually all DaVita dialysis clinics in the United States. After time-dependent and multivariate adjustment for case mix, administered intravenous iron and erythropoietin doses, and available surrogates of MICS, serum ferritin levels between 200 and 1200 ng/ml (reference 100 to 199 ng/ml), serum iron levels between 60 and 120 g/ml (reference 50 to 59 g/ml), and iron saturation ratio between 30 and 50% (reference 45 to 50%) were associated with the lowest all-cause and cardiovascular death risks. Compared with those who did not receive intravenous iron, administered intravenous iron up to 400 mg/mo was associated with improved survival, whereas doses >400 mg/mo tended to be associated with higher death rates. The association between serum ferritin levels >800 ng/ml and mortality in MHD patients seems to be due mostly to the confounding effects of MICS. I n patients who are on maintenance hemodialysis (MHD), markers of anemia, including low blood hemoglobin concentrations, are associated with poor clinical outcomes (1,2). Consequently, management of anemia by recombinant human erythropoietin (EPO) by increasing serum hemoglobin toward the target of 11.0 to 12.0 g/dl is reported consistently to improve outcome measures in MHD patients (3-6). However, much controversy exists with regard to the association between measures of iron stores or changes in these values by iron administration and clinical outcome in these individuals (7). Although in the pre-EPO era iron overload was a major cause of morbidity in MHD patients, its significance in the post-EPO era remains unclear. A recent observational study in 1283 MHD patients indicated that a low, rather than a high, baseline serum iron quartile was associated with increased mortality and hospitalization over 12 mo of observation (8). Even though quartile analysis enables us to uncover nonlinear relationships, large sample sizes with repeated measures are needed to compare the mortality predictability of smaller increments of iron markers. Moreover, the association between other iron markers and survival remains to be determined.Many observational studies have examined the association between a baseline laboratory value at the start of the cohort and the survival and ignored variations in clinical and laboratory measures over time. It is not clear whether longitudinal changes in...

Leptin, the gene product of the ob gene, is important in the control of appetite in rodents and may have an important role in humans. The clearance of leptin from the circulation is unknown. As the leptin receptor is present in the kidney, we evaluated the role of the kidney in removing circulating leptin in humans. We measured leptin in aortic and renal vein plasma in 8 patients with intact renal function and 6 patients with impaired renal function who were undergoing elective cardiac catheterization. Renal blood flow was measured in all patients to calculate net mass balance across the kidney. In patients with intact renal function there is net renal uptake of 12% of circulating leptin, whereas in patients with renal insufficiency there is no renal uptake of leptin. In a separate cohort of 36 patients with end-stage renal failure on hemodialysis, peripheral leptin levels factored for body mass index was increased by > fourfold as compared to a group of healthy controls (N = 338). In addition, plasma leptin is not cleared by hemodialysis with a modified cellulose membrane. Additional studies are required to evaluate the role of leptin in mediating the anorexia of uremia.

SFGC is well tolerated when given by intravenous push without a test dose. SFGC has a significantly lower incidence of drug intolerance and life-threatening events as compared to previous studies using iron dextran. The routine use of iron dextran in hemodialysis patients should be discontinued.

SummaryEstimates suggest that one third of United States health care spending results from overuse or misuse of tests, procedures, and therapies. The American Board of Internal Medicine Foundation, in partnership with Consumer Reports, initiated the "Choosing Wisely" campaign to identify areas in patient care and resource use most open to improvement. Nine subspecialty organizations joined the campaign; each organization identified five tests, procedures, or therapies that are overused, are misused, or could potentially lead to harm or unnecessary health care spending. Each of the American Society of Nephrology's (ASN's) 10 advisory groups submitted recommendations for inclusion. The ASN Quality and Patient Safety Task Force selected five recommendations based on relevance and importance to individuals with kidney disease.Recommendations selected were: (1) Do not perform routine cancer screening for dialysis patients with limited life expectancies without signs or symptoms; (2) do not administer erythropoiesis-stimulating agents to CKD patients with hemoglobin levels ‡10 g/dl without symptoms of anemia; (3) avoid nonsteroidal anti-inflammatory drugs in individuals with hypertension, heart failure, or CKD of all causes, including diabetes; (4) do not place peripherally inserted central catheters in stage 3-5 CKD patients without consulting nephrology; (5) do not initiate chronic dialysis without ensuring a shared decision-making process between patients, their families, and their physicians.These five recommendations and supporting evidence give providers information to facilitate prudent care decisions and empower patients to actively participate in critical, honest conversations about their care, potentially reducing unnecessary health care spending and preventing harm.

Patients with a history of iron dextran sensitivity had approximately sevenfold higher rates of reaction to both placebo and SFGC compared to iron dextran tolerant patients. However, logistic regression analysis, performed to account for the higher reaction rate to placebo, suggests that this increased reactivity was not drug-specific nor immunologically mediated, but represented host idiosyncrasy. These results support the conclusions that reactions to SFGC can be attributed to pseudoallergy, and that SFGC is not a true allergen.

No abstract

Repeated doses of SFGC are very well tolerated in haemodialysis patients. No life-threatening events were observed in over 13,000 doses administered. Administration of SFGC to patients using ACEI is safe and does not increase the incidence or severity of adverse events to SFGC.

Background. Treatment of patients receiving hemodialysis who have anemia varies considerably despite the availability of established practice guidelines from the National Kidney Foundation Kidney Disease Outcomes Quality Initiative (KDOQI). Objective. To compare actual use of erythropoietin (EPO) and intravenous (IV) iron with that recommended in KDOQI guidelines. Methods. A budget impact model was used to calculate costs per member per month (PMPM) for actual practice versus recommended practice were calculated using Medicare reimbursement rates for EPO and IV iron. A sensitivity analysis tested the impact of varying the recommended dosages by AE50%. Results. For EPO, a net savings PMPM of $257 (if administered by IV ) or $252 (if administered subcutaneously) could be achieved with adherence to KDOQI guidelines. Adherence to KDOQI recommendations for IV iron would increase Medicare reimbursements for this drug by an estimated $6 PMPM. Sensitivity analysis revealed a significant potential savings even if the dose of EPO used in practice was increased by 50%. Conclusions. In the face of limited resources and changing reimbursement policies, dialysis providers will need to find ways of reducing costs without compromising the quality of care. Clinical practice guidelines such as KDOQI can be used to assist providers in meeting this challenge. Among Medicare patients who have anemia of chronic kidney disease, adherence to KDOQI treatment recommendations could translate into a significant savings for Medicare. Our findings provide incentive for payers and dialysis centers to examine their current practices and improve the quality and efficiency of anemia treatment in this population.