IBD
Conditions
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 .
Interventions
administered IV
DRUGFerric Carboxymaltose
administered IV
Sponsors
Pharmacosmos A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
double-blinded
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
include: * Men or women ≥ 18 years * Subjects diagnosed with IBD * Hb \< 13 g/dL * Body weight ≥ 50 kg * S-ferritin \<100 ng/mL * eGFR ≥ 65 mL/min/1.73 m2 * S-phosphate \> 2.5 mg/dL * Oral iron preparations are ineffective or cannot be used or where there is a clinical need to de-liver iron rapidly * Willingness to participate and signing the Informed Consent Form (ICF)
Exclusion criteria
include: * Anaemia predominantly caused by factors other than IDA according to Investigator's judgment * Hb ≥ 10 g/dL and body weight \< 70 kg * Hemochromatosis or other iron storage disorders * Known hypersensitivity reaction to any component of iron isomaltoside or ferric carboxymaltose * Previous serious hypersensitivity reactions to any IV iron compounds * Treatment with IV iron within the last 30 days prior to screening * Treatment with erythropoietin or erythropoietin-stimulation agents, red blood cell transfusion, radiotherapy, and/or chemotherapy within the last 30 days prior to screening * Received an investigational drug within the last 30 days prior to screening * Planned surgical procedure within the trial period * hepatic enzymes \> 3 times upper limit of normal * Surgery under general anaesthesia within the last 30 days prior to screening * Any non-viral infection within the last 30 days prior to screening * Alcohol or drug abuse within the past 6 months * Untreated hyperparathyroidism * Kidney transplantation * Conditions that interfere with the subject's ability to understand the requirements of the trial and/or presumable non-compliance * Any other laboratory abnormality, medical condition, or psychiatric disorders which, in the opinion of the Investigator, will put the subject's disease management at risk or may result in the subject being unable to comply with the trial requirements * Pregnant or nursing women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of hypophosphatemia | any time from baseline to day 35 | s-phosphate \< 2 mg/dL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of hypophosphatemia | any time from baseline to week 10 | s-phosphate \< 2 mg/dL |
| Incidence of s-phosphate < 1.0 mg/dL | any time from baseline to day 35 | s-phosphate \< 1.0 mg/dL |
| Time with hypophosphatemia | number of days any time from baseline to week 10 | time with s-phosphate \< 2.0 mg/dL |
Countries
Denmark
Outcome results
None listed