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

NCT03466983 | Completed Phase 4

• 1 other identifier: P-Monofer-IBD-03
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

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

Conditions

IBD

Outcome Measures

Primary Outcomes (1)

• Incidence of hypophosphatemia

  s-phosphate \< 2 mg/dL

  any time from baseline to day 35

Secondary Outcomes (3)

• Incidence of hypophosphatemia

  any time from baseline to week 10

• Incidence of s-phosphate < 1.0 mg/dL

  any time from baseline to day 35

• Time with hypophosphatemia

  number of days any time from baseline to week 10

Study Arms (2)

Iron Isomaltoside

EXPERIMENTAL

Iron Isomaltoside (Monofer) administered IV

Drug: Iron Isomaltoside

Ferric Carboxymaltose

ACTIVE COMPARATOR

Ferric Carboxymaltose (Injectafer) administered IV

Drug: Ferric Carboxymaltose

Interventions

Iron Isomaltoside DRUG

administered IV

Also known as: Monofer

Iron Isomaltoside

Ferric Carboxymaltose DRUG

administered IV

Also known as: Ferinject

Ferric Carboxymaltose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Pharmacosmos A/S: lead

Study Sites (1)

Pharmacosmos Investigational Site

Silkeborg, 8600, Denmark

Location

Related Publications (1)

• Bjorner JB, Kennedy N, Lindgren S, Pollock RF. Hypophosphatemia attenuates improvements in vitality after intravenous iron treatment in patients with inflammatory bowel disease. Qual Life Res. 2024 Aug;33(8):2285-2294. doi: 10.1007/s11136-024-03642-y. Epub 2024 Jun 14.

  PMID: 38874697 DERIVED

MeSH Terms

Interventions

iron isomaltoside 1000; ferric carboxymaltose

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double-blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2018
• First Posted: March 15, 2018
• Study Start: May 23, 2018
• Primary Completion: May 25, 2020
• Study Completion: May 25, 2020
• Last Updated: February 21, 2021

Record last verified: 2021-02

Locations

DK (1)