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CompletedNCT03466983Updated Feb 21, 2021

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 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

Phase
Phase 4
Study type
Interventional
Enrollment
97
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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 .

02

Conditions studied

03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

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.
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
97 participants (actual)

Study arms

  • Experimental
    Iron Isomaltoside

    Iron Isomaltoside (Monofer) administered IV

    Drug: Iron Isomaltoside

  • Active comparator
    Ferric Carboxymaltose

    Ferric Carboxymaltose (Injectafer) administered IV

    Drug: Ferric Carboxymaltose

Interventions

  • DrugIron Isomaltoside

    administered IV

    Also known as: Monofer

  • DrugFerric Carboxymaltose

    administered IV

    Also known as: Ferinject

05

What researchers measure

Primary outcomes

  1. Incidence of hypophosphatemia

    s-phosphate \< 2 mg/dL

    Time frame: any time from baseline to day 35

Secondary outcomes

  1. Incidence of hypophosphatemia

    s-phosphate \< 2 mg/dL

    Time frame: any time from baseline to week 10

  2. Incidence of s-phosphate < 1.0 mg/dL

    s-phosphate \< 1.0 mg/dL

    Time frame: any time from baseline to day 35

  3. Time with hypophosphatemia

    time with s-phosphate \< 2.0 mg/dL

    Time frame: number of days any time from baseline to week 10

06

Study locations

1 site
  • Pharmacosmos Investigational Site
    Silkeborg, 8600, Denmark
07

Registry details

Key details

Study ID
NCT03466983
Lead sponsor
Pharmacosmos A/S
Responsible party
Sponsor
First posted
Mar 15, 2018
Start date
May 23, 2018
Primary completion
May 25, 2020
Completion
May 25, 2020
Last update
Feb 21, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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