NCT03466983

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

A Randomized, Double-blinded, Comparative Trial Comparing the Incidence of Hypophosphatemia in Relation to Repeated Treatment Courses of Iron Isomaltoside and Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia Due to Inflammatory Bowel Disease

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 97 (actual)
• Sponsor: Pharmacosmos A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 .

Conditions

• IBD

Interventions

Type	Name	Description
DRUG	Iron Isomaltoside	administered IV
DRUG	Ferric Carboxymaltose	administered IV

Timeline

• Start date: 2018-05-23
• Primary completion: 2020-05-25
• Completion: 2020-05-25
• First posted: 2018-03-15
• Last updated: 2021-02-21

Locations

1 site across 1 country: Denmark