SO035THE SAFETY OF INTRAVENOUS (IV) FERRIC CARBOXYMALTOSE (FCM) IN PATIENTS WITH NON-DIALYSIS DEPENDENT CKD (ND-CKD): 1-YEAR RESULTS FROM THE FIND-CKD TRIAL

Abstract

Introduction and Aims: There are ongoing concerns regarding the safety of IV iron in patients with ND‐CKD in terms of infection, cardiac disorders and oxidative stress, but robust long‐term data are scarce. Methods: In the 56‐week, open‐label, multicentre, prospective FIND‐CKD study, anaemic patients with ND‐CKD and iron deficiency not receiving ESA therapy were randomised (1:1:2) to IV ferric carboxymaltose (FCM), targeting higher (400‐600μg/L, HF‐FCM) or lower (100‐200μg/L, LF‐FCM) ferritin, or oral iron. In a new analysis, the incidence of adverse events (AE) or serious AEs (SAEs) was calculated per 100 patient years (PY) of follow‐up. Results: Cumulative follow‐up was 139, 129 and 243 PY in the HF‐FCM, LF‐FCM and oral iron groups, respectively (N=616). The incidences of any AE and SAE per 100 PY were similar between groups, as was the incidence of infections or cardiac disorders (Table). The incidence of major cardiac events was 3.6, 2.3 and 3.3 per 100 PY, respectively, in the HF‐FCM, LF‐FCM and oral iron groups. Median time to first AE or SAE was shorter with oral iron vs either FCM group. No SAE was reported as related to FCM. Ferritin ≥800ng/mL occurred at least once in 26.6%, 0% and 0.3% of patients in the HF‐FCM, LF‐FCMand oral iron groups. Mean total FCM dose was 2,561mg iron in patients with at least one ferritin ≥800ng/mL vs 2,685mg in the HF‐FCM group overall. In HF‐FCM patients with ferritin ≥800ng/mL at least once, the incidence of any AE (80.5%) was not higher than the overall cohort (81.8%). In the subset of patients with eGFR data at both baseline and month 12 (353/613, 57.6%), change in eGFR from baseline to month 12 was 0.7, ‐0.9 and ‐0.9mL/min/1.73m2 in the HF‐FCM, LF‐FCM and oral iron groups, respectively (least square means). Across all FCM‐treated patients, the change was ‐0.3, ‐1.1, ‐1.5 and +1.6mL/min/1.73m2 for patients in ascending quartiles of total FCM dose (≤1200, >1200‐2000, >2000‐2600 and >2600mg iron). Conclusions: In this large, randomised study of ND‐CKD patients followed for 12 months, there was no indication of a safety signal using IV FCM targeting a higher ferritin range, including patients in whom ferritin exceeded 800ng/mL. (Table Presented).