PMID- 22874106
OWN - NLM
STAT- MEDLINE
DCOM- 20121211
LR  - 20190608
IS  - 0301-0430 (Print)
IS  - 0301-0430 (Linking)
VI  - 78
IP  - 3
DP  - 2012 Sep
TI  - Factors affecting response and tolerability to ferumoxytol in nondialysis chronic 
      kidney disease patients.
PG  - 181-8
AB  - BACKGROUND: Ferumoxytol is a unique intravenous (i.v.) iron therapy. This report 
      examines factors affecting hemoglobin response to i.v. ferumoxytol, and the 
      relationship between hematologic parameters, concomitant 
      erythropoiesis-stimulating agents (ESA), and adverse events (AEs) in nondialysis 
      CKD patients. METHODS: A series of post-hoc efficacy and safety analyses were 
      performed using pooled data from two identically designed Phase III studies in 
      608 nondialysis CKD patients randomized to receive two 510 mg i.v. injections of 
      ferumoxytol within 5 +/- 3 days versus oral iron. RESULTS: Ferumoxytol resulted in 
      a significant increase in hemoglobin in the presence and absence of ESA, and 
      across a range of baseline hemoglobin, transferrin saturation, ferritin, and 
      reticulocyte hemoglobin content levels. Adverse event rates with ferumoxytol were 
      similar across quartiles of change in hemoglobin; there were no trends suggesting 
      an increased rate of cardiovascular AEs with higher maximum achieved hemoglobin 
      or faster rate of hemoglobin rise. There was no meaningful difference in the rate 
      of AEs, serious AEs, and cardiovascular AEs between patients receiving or not 
      receiving ESA. CONCLUSIONS: These analyses add to the knowledge of predictors of 
      response and safety outcomes associated with i.v. iron therapy in nondialysis CKD 
      patients.
FAU - Fishbane, Steven
AU  - Fishbane S
AD  - Hofstra North Shore LIJ, School of Medicine, Great Neck, NY 11021, USA. 
      sfishbane@gmail.com
FAU - Bolton, W Kline
AU  - Bolton WK
FAU - Winkelmayer, Wolfgang C
AU  - Winkelmayer WC
FAU - Strauss, William
AU  - Strauss W
FAU - Li, Zhu
AU  - Li Z
FAU - Pereira, Brian J G
AU  - Pereira BJ
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - Germany
TA  - Clin Nephrol
JT  - Clinical nephrology
JID - 0364441
RN  - 0 (Hematinics)
RN  - 0 (Hemoglobins)
RN  - 0 (Transferrin)
RN  - 9007-73-2 (Ferritins)
RN  - XM0M87F357 (Ferrosoferric Oxide)
SB  - IM
MH  - Aged
MH  - Anemia, Iron-Deficiency/*blood/*drug therapy/etiology
MH  - Cardiovascular Diseases/chemically induced
MH  - Female
MH  - Ferritins/blood
MH  - Ferrosoferric Oxide/adverse effects/*therapeutic use
MH  - Hematinics/adverse effects/*therapeutic use
MH  - Hemoglobins/*metabolism
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Renal Insufficiency, Chronic/blood/complications
MH  - Reticulocytes/metabolism
MH  - Transferrin/metabolism
EDAT- 2012/08/10 06:00
MHDA- 2012/12/12 06:00
CRDT- 2012/08/10 06:00
PHST- 2012/08/10 06:00 [entrez]
PHST- 2012/08/10 06:00 [pubmed]
PHST- 2012/12/12 06:00 [medline]
AID - 9499 [pii]
AID - 10.5414/cn107397 [doi]
PST - ppublish
SO  - Clin Nephrol. 2012 Sep;78(3):181-8. doi: 10.5414/cn107397.