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 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

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

Study Overview

• Status: Completed
• Conditions: IBD
• Intervention / Treatment: Drug: Iron Isomaltoside; Drug: Ferric Carboxymaltose

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 .

• Study Type: Interventional
• Enrollment (Actual): 97
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Silkeborg, Denmark, 8600
    • Pharmacosmos Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Iron Isomaltoside; Iron Isomaltoside (Monofer) administered IV	Drug: Iron Isomaltoside; administered IV; Other Names: Monofer
Active Comparator: Ferric Carboxymaltose; Ferric Carboxymaltose (Injectafer) administered IV	Drug: Ferric Carboxymaltose; administered IV; Other Names: Ferinject

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of hypophosphatemia	s-phosphate < 2 mg/dL	any time from baseline to day 35

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of hypophosphatemia	s-phosphate < 2 mg/dL	any time from baseline to week 10
Incidence of s-phosphate < 1.0 mg/dL	s-phosphate < 1.0 mg/dL	any time from baseline to day 35
Time with hypophosphatemia	time with s-phosphate < 2.0 mg/dL	number of days any time from baseline to week 10

Collaborators and Investigators

• Sponsor: Pharmacosmos A/S

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2018
• Primary Completion (Actual): May 25, 2020
• Study Completion (Actual): May 25, 2020

Study Registration Dates

• First Submitted: March 6, 2018
• First Submitted That Met QC Criteria: March 14, 2018
• First Posted (Actual): March 15, 2018

Study Record Updates

• Last Update Posted (Actual): February 21, 2021
• Last Update Submitted That Met QC Criteria: February 18, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Hematologic Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Anemia, Hypochromic; Anemia; Iron Metabolism Disorders; Phosphorus Metabolism Disorders; Inflammatory Bowel Diseases; Anemia, Iron-Deficiency; Hypophosphatemia; Hematinics; Iron isomaltoside 1000
• Other Study ID Numbers: P-Monofer-IBD-03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No