Iron isomaltoside 1000: a new intravenous iron for treating iron deficiency in chronic kidney disease
| Autor: | Lars L. Thomsen, Jan Wilske, Björn Wikström, Peter Bárány, Philip A. Kalra, Søren Ladefoged, Sunil Bhandari |
|---|---|
| Rok vydání: | 2011 |
| Předmět: |
Adult
Male medicine.medical_specialty Time Factors Anemia Iron medicine.medical_treatment Disaccharides Ferric Compounds Gastroenterology Hemoglobins Young Adult Renal Dialysis Iron Isomaltoside 1000 Internal medicine medicine Humans Infusions Intravenous Dialysis Aged Aged 80 and over chemistry.chemical_classification Analysis of Variance Anemia Iron-Deficiency business.industry Transferrin saturation Transferrin Iron Deficiencies Iron deficiency Middle Aged medicine.disease Surgery Europe Treatment Outcome chemistry Iron-deficiency anemia Nephrology Ferritins Injections Intravenous Hematinics Female Kidney Diseases business Biomarkers Kidney disease |
| Zdroj: | Journal of Nephrology. 24:589-596 |
| ISSN: | 1121-8428 |
| DOI: | 10.5301/jn.2011.6248 |
| Popis: | 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, multi-center 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 |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|