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

IBD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03466983
• Other study ID #: P-Monofer-IBD-03
• Status: Completed
• Phase: Phase 4
• Start date: May 23, 2018
• Est. completion date: May 25, 2020

Study information

• Verified date: February 2021
• Source: Pharmacosmos A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: May 25, 2020
• Est. primary completion date: May 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Hypophosphatemia
• IBD
• Inflammatory Bowel Diseases

Intervention

Drug:
• Iron Isomaltoside
administered IV
• Ferric Carboxymaltose
administered IV

Locations

Country	Name	City	State
Denmark	Pharmacosmos Investigational Site	Silkeborg

Sponsors (1)

Lead Sponsor	Collaborator
Pharmacosmos A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of hypophosphatemia	s-phosphate < 2 mg/dL	any time from baseline to day 35
Secondary	Incidence of hypophosphatemia	s-phosphate < 2 mg/dL	any time from baseline to week 10
Secondary	Incidence of s-phosphate < 1.0 mg/dL	s-phosphate < 1.0 mg/dL	any time from baseline to day 35
Secondary	Time with hypophosphatemia	time with s-phosphate < 2.0 mg/dL	number of days any time from baseline to week 10