Treatment with iron isomaltoside and ferric carboxymaltose in subjects with iron deficiency anaemia due to inflammatory bowel disease and comparison of the incidence of hypophosphatemia
Existing IV iron complexes differ in relation to the compounds capability to induce unintended hypophosphatemia to a degree defined as medical significant. This trial is designed evaluate the effect of IV iron isomaltoside compared to IV ferric carboxymaltose on phosphate in subjects with IDA due to inflammatory bowel disease .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
97
administered IV
administered IV
Pharmacosmos Investigational Site
Silkeborg, Denmark
Incidence of hypophosphatemia
s-phosphate \< 2 mg/dL
Time frame: any time from baseline to day 35
Incidence of hypophosphatemia
s-phosphate \< 2 mg/dL
Time frame: any time from baseline to week 10
Incidence of s-phosphate < 1.0 mg/dL
s-phosphate \< 1.0 mg/dL
Time frame: any time from baseline to day 35
Time with hypophosphatemia
time with s-phosphate \< 2.0 mg/dL
Time frame: number of days any time from baseline to week 10
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