PMID- 21240875
OWN - NLM
STAT- MEDLINE
DCOM- 20120111
LR  - 20221222
IS  - 1724-6059 (Electronic)
IS  - 1121-8428 (Linking)
VI  - 24
IP  - 5
DP  - 2011 Sep-Oct
TI  - Iron isomaltoside 1000: a new intravenous iron for treating iron deficiency in 
      chronic kidney disease.
PG  - 589-96
LID - 10.5301/JN.2011.6248 [doi]
AB  - 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.
FAU - Wikstrom, Bjorn
AU  - Wikstrom B
AD  - Department of Renal Medicine, Uppsala University Hospital, Uppsala, Sweden. 
      bjornwik@yahoo.com
FAU - Bhandari, Sunil
AU  - Bhandari S
FAU - Barany, Peter
AU  - Barany P
FAU - Kalra, Philip A
AU  - Kalra PA
FAU - Ladefoged, Soren
AU  - Ladefoged S
FAU - Wilske, Jan
AU  - Wilske J
FAU - Thomsen, Lars L
AU  - Thomsen LL
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - Italy
TA  - J Nephrol
JT  - Journal of nephrology
JID - 9012268
RN  - 0 (Biomarkers)
RN  - 0 (Disaccharides)
RN  - 0 (Ferric Compounds)
RN  - 0 (Hematinics)
RN  - 0 (Hemoglobins)
RN  - 0 (Transferrin)
RN  - 3M6325NY1R (iron isomaltoside 1000)
RN  - 9007-73-2 (Ferritins)
RN  - E1UOL152H7 (Iron)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Analysis of Variance
MH  - Anemia, Iron-Deficiency/blood/*drug therapy/etiology
MH  - Biomarkers/blood
MH  - Disaccharides/*administration & dosage/adverse effects
MH  - Europe
MH  - Female
MH  - Ferric Compounds/*administration & dosage/adverse effects
MH  - Ferritins/blood
MH  - Hematinics/*administration & dosage/adverse effects
MH  - Hemoglobins/metabolism
MH  - Humans
MH  - Infusions, Intravenous
MH  - Injections, Intravenous
MH  - Iron/blood
MH  - *Iron Deficiencies
MH  - Kidney Diseases/blood/complications/*therapy
MH  - Male
MH  - Middle Aged
MH  - *Renal Dialysis
MH  - Time Factors
MH  - Transferrin/metabolism
MH  - Treatment Outcome
MH  - Young Adult
EDAT- 2011/01/18 06:00
MHDA- 2012/01/12 06:00
CRDT- 2011/01/18 06:00
PHST- 2010/08/25 00:00 [accepted]
PHST- 2011/01/18 06:00 [entrez]
PHST- 2011/01/18 06:00 [pubmed]
PHST- 2012/01/12 06:00 [medline]
AID - 1FDBF055-7436-4798-A167-364FA5FA979F [pii]
AID - 10.5301/JN.2011.6248 [doi]
PST - ppublish
SO  - J Nephrol. 2011 Sep-Oct;24(5):589-96. doi: 10.5301/JN.2011.6248.