FP396A PROSPECTIVE OBSERVATIONAL STUDY OF THE EFFICACY, SAFETY AND TOLERABILITY OF IRON ISOMALTOSIDE 1000 IN THE TREATMENT OF IRON DEFICIENCY ANEMIA IN PATIENTS WITH CHRONIC RENAL FAILURE

Abstract

Introduction and Aims: Chronic kidney disease (CKD) and renal failure is frequently associated with renal anemia. Anemia in CKD patients is commonly treated by the use of iron and/or erythopoiesis-stimulating agents (ESAs). Iron isomaltoside 1000 is a high dose iv iron which has been approved in Germany and other European countries. The objective of this observational study was to prospectively collect data for the treatment routine, efficacy, safety and tolerability of iron isomaltoside 1000 (Monofer®) in CKD patients. Methods: This non-interventional study included 695 adult dialysis and non-dialysis dependent patients with CKD stage 3-5 designated for a treatment with iron isomaltoside 1000 based on therapeutic procedure of the attending physician. Treatment was performed according to usual daily practice and in accordance with the authorized indication. The collected data were documented at baseline, at intermediate (after 3 months) and at final (after 9months) examination. Results: Mean age of the patients was 71.2 ± 13.1 years, most of the patients were in stage of chronic hemodialysis (n=533), no dialysis was necessary for 148 patients. The most common single dose of iron isomaltoside 1000 was 500 mg (39.3 % - 42.8 %). Dose schedule was quite diverse, iron isomaltoside 1000 was most often administered once per month. Considering the cumulative mean dose of parenteral iron, patients received a total value of 2413 mg during the whole observation period. A total of 525 patients were concomitantly treated with erythropoiesis-stimulating agents (ESAs). The proportion of patients treated with ESA decreased under iron replacement therapy. Despite the broad distribution of values the reduction of doses of concomitant erythropoietin treatment was statistically significant (p<0.0019). During the course of the study mean hemoglobin values increased significantly from 11.0 ± 1.7 g/dl at admission to 11.6 ± 1.6 g/dl at last documentation (p<0.0001). Ferritin values increased statistically significant (p<0.0001) from 311 μg/ at baseline to 638 μg/dl at last examination. Mean TSAT values changed during the iron treatment from 19.4 % to 28.5 %. The change of TSAT was statistically significant (p<0.0001). Renal function (eGFR) remained stable. There was no statistically significant change in serum phosphate levels. No patient experienced adverse drug reaction. A total of 88 adverse events (AE) were documented for 71 patients. The most frequently stated AEs were sepsis (12 patients) and circulatory collapse (11 patients). All reported adverse events were without relation to the treatment with iron isomaltoside 1000. Conclusions: The cumulative mean iron dose over a 9 month period was 2413 mg in a mixed CKD population and to cover this need the administration of iron isomaltoside 1000 was well tolerated and effective. It was often administered in high single iron doses in real life settings and hence it takes only a few visits to cover the cumulative iron need. Concomitant treatment with parenteral iron shows an ESA saving effect in CKD patients under epoetin therapy. Thus, iron isomaltoside 1000 offers a cost-effective parenteral iron therapy with high dose flexibility, including the possibility to correct iron deficiency with fewer administrations.