Iron isomaltoside 1000: a new intravenous iron for treating iron deficiency in chronic kidney disease.
BACKGROUND
Patients with chronic kidney disease (CKD) often suffer from iron deficiency anemia necessitating treatment with intravenous iron. This study was designed to assess the safety of iron isomaltoside 1000 (Monofer) in CKD patients. The secondary objective was to assess its effect on iron deficiency anemia.


METHODS
This open-label, noncomparative, multicenter trial assigned 182 patients with CKD (n=161 in dialysis and n=21 in predialysis) to iron isomaltoside 1000 either as 4 intravenous bolus injections of 100-200 mg iron per dose or as a fast high-dose infusion at baseline. Patients were generally undergoing erythropoiesis-stimulating agent (ESA) treatment (82%), and the dosage was to be kept constant during the trial. They were either switched from an existing parenteral maintenance therapy (n=144) or were not currently being treated with parenteral iron (n=38). Frequency of adverse events (AEs) and changes in markers of iron deficiency anemia were measured during 8 weeks from baseline.


RESULTS
Nineteen treatment-related AEs occurred in 13 patients (7.1%) and after 584 treatments (3.3%). No anaphylactic or delayed allergic reactions were observed. There were no clinically significant changes in routine clinical laboratory tests or vital signs. Hemoglobin increased from 99.2 g/L (SD=9.0) at baseline to 111.2 g/L (SD=14.7) at week 8 in patients not currently treated with parenteral iron (p<0.001) and increased slightly or stabilized in patients in maintenance therapy. S-Ferritin, s-iron and transferrin saturation increased significantly at all visits.


CONCLUSIONS
Iron isomaltoside 1000 was clinically well tolerated, safe and effective. This new intravenous iron may offer a further valuable choice in treating the anemia of CKD.
Department of Renal Medicine, Uppsala University Hospital, Uppsala, Sweden. bjornwik@yahoo.com
Björn
B
Wikström
Sunil
S
Bhandari
Peter
P
Barany
Philip A
PA
Kalra
Søren
S
Ladefoged
Jan
J
Wilske
Lars L
LL
Thomsen
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000704:Analysis of Variance; D018798:Anemia, Iron-Deficiency / Q000097:blood / Q000188:drug therapy* / Q000209:etiology; D015415:Biomarkers / Q000097:blood; D004187:Disaccharides / Q000008:administration & dosage* / Q000009:adverse effects; D005060:Europe; D005260:Female; D005290:Ferric Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D005293:Ferritins / Q000097:blood; D006397:Hematinics / Q000008:administration & dosage* / Q000009:adverse effects; D006454:Hemoglobins / Q000378:metabolism; D006801:Humans; D007262:Infusions, Intravenous; D007275:Injections, Intravenous; D007501:Iron / Q000097:blood; D000090463:Iron Deficiencies; D007674:Kidney Diseases / Q000097:blood / Q000150:complications / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D006435:Renal Dialysis; D013997:Time Factors; D014168:Transferrin / Q000378:metabolism; D016896:Treatment Outcome; D055815:Young Adult
D015415:Biomarkers; D004187:Disaccharides; D005290:Ferric Compounds; D006397:Hematinics; D006454:Hemoglobins; D014168:Transferrin; C557707:iron isomaltoside 1000; D005293:Ferritins; D007501:Iron