A Trial Comparing the Incidence of Hypophosphatemia in Relation to Treatment With Iron Isomaltoside and Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia Due to Inflammatory Bowel Disease
- Registration Number
- NCT03466983
- Lead Sponsor
- Pharmacosmos A/S
- Brief Summary
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
- Detailed Description
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 .
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 97
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Iron Isomaltoside Iron Isomaltoside Iron Isomaltoside (Monofer) administered IV Ferric Carboxymaltose Ferric Carboxymaltose Ferric Carboxymaltose (Injectafer) administered IV
- Primary Outcome Measures
Name Time Method Incidence of hypophosphatemia any time from baseline to day 35 s-phosphate \< 2 mg/dL
- Secondary Outcome Measures
Name Time Method Incidence of hypophosphatemia any time from baseline to week 10 s-phosphate \< 2 mg/dL
Time with hypophosphatemia number of days any time from baseline to week 10 time with s-phosphate \< 2.0 mg/dL
Incidence of s-phosphate < 1.0 mg/dL any time from baseline to day 35 s-phosphate \< 1.0 mg/dL
Trial Locations
- Locations (1)
Pharmacosmos Investigational Site
🇩🇰Silkeborg, Denmark