Safety of intravenous ferric carboxymaltose versus oral iron in patients with nondialysis-dependent CKD: an analysis of the 1-year FIND-CKD trial.

Background: The evidence base regarding the safety of intravenous (IV) iron therapy in patients with chronic kidney disease (CKD) is incomplete and largely based on small studies of relatively short duration. Methods: FIND-CKD (ClinicalTrials.gov number NCT00994318) was a 1-year, open-label, multicenter, prospective study of patients with nondialysis-dependent CKD, anemia and iron deficiency randomized (1:1:2) to IV ferric carboxymaltose (FCM), targeting higher (400-600 µg/L) or lower (100-200 µg/L) ferritin, or oral iron. A post hoc analysis of adverse event rates per 100 patient-years was performed to assess the safety of FCM versus oral iron over an extended period. Results: The safety population included 616 patients. The incidence of one or more adverse events was 91.0, 100.0 and 105.0 per 100 patient-years in the high ferritin FCM, low ferritin FCM and oral iron groups, respectively. The incidence of adverse events with a suspected relation to study drug was 15.9, 17.8 and 36.7 per 100 patient-years in the three groups; for serious adverse events, the incidence was 28.2, 27.9 and 24.3 per 100 patient-years. The incidence of cardiac disorders and infections was similar between groups. At least one ferritin level ≥800 µg/L occurred in 26.6% of high ferritin FCM patients, with no associated increase in adverse events. No patient with ferritin ≥800 µg/L discontinued the study drug due to adverse events. Estimated glomerular filtration rate remained the stable in all groups. Conclusions: These results further support the conclusion that correction of iron deficiency anemia with IV FCM is safe in patients with nondialysis-dependent CKD

Managerial Discretion and Constraints: A Bounded Leadership Model

Purpose: We propose and test a new leadership model. Our model is an extension of the leaderplex model which proposes that leader cognitive and social complexities are linked with leader effec tiveness indirectly, in a mediation scheme, through behavioral complexity. We enhance the leader plex model with a leader’s degree of managerial discretion as the moderator of the links in this mediation format. Methodology: We test our model with a moderated mediation approach (Baron-Kenny four-step procedure and Preacher-Hayes bootstrapping methods). Findings: We use results of interviews with top leaders in Poland and demonstrate that a leader’s managerial discretion is a moderator affecting the mediation scheme assumed in the leaderplex model. Limitations: The sample size is only 29 leaders. To preserve the respondents’ anonymity, their opinions were evaluated by only one researcher who interviewed them directly. The results may be country specific (Poland). Originality: We define new boundary conditions for the leaderplex model by showing importance of a leader’s real position (managerial discretion) in an organization. Specifically, we show that the nature of the relationships between the variables of interest will change when a leader operates in one physical environment (e.g., high managerial discretion) rather than another (e.g., low managerial discretion). nul