A Phase 4 interventional study of Iron Isomaltoside and Ferric Carboxymaltose in IBD, sponsored by Pharmacosmos A/S. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-21.
Sponsored by Pharmacosmos A/S · Phase 4, Interventional, and Treatment
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 .
Exclusion Criteria include:
Iron Isomaltoside (Monofer) administered IV
Drug: Iron Isomaltoside
Ferric Carboxymaltose (Injectafer) administered IV
Drug: Ferric Carboxymaltose
administered IV
Also known as: Monofer
administered IV
Also known as: Ferinject
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
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Pharmacosmos A/S