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

• ClinicalTrials.gov Identifier: NCT03466983
• Recruitment Status: Recruiting
• First Posted: March 15, 2018
• Last Update Posted: March 4, 2020
• Sponsor: Pharmacosmos A/S
• Information provided by (Responsible Party): Pharmacosmos A/S

Study Description

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

Condition or disease	Intervention/treatment	Phase
IBD	Drug: Iron Isomaltoside; Drug: Ferric Carboxymaltose	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: double-blinded
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: May 23, 2018
• Estimated Primary Completion Date: April 30, 2020
• Estimated Study Completion Date: July 30, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Iron Isomaltoside; Iron Isomaltoside (Monofer) administered IV	Drug: Iron Isomaltoside; administered IV; Other Name: Monofer
Active Comparator: Ferric Carboxymaltose; Ferric Carboxymaltose (Injectafer) administered IV	Drug: Ferric Carboxymaltose; administered IV; Other Name: Ferinject

Outcome Measures

Primary Outcome Measures :

1. Incidence of hypophosphatemia [ Time Frame: any time from baseline to day 35 ]
   s-phosphate < 2 mg/dL

Secondary Outcome Measures :

1. Incidence of hypophosphatemia [ Time Frame: any time from baseline to week 10 ]
   s-phosphate < 2 mg/dL
2. Incidence of s-phosphate < 1.0 mg/dL [ Time Frame: any time from baseline to day 35 ]
   s-phosphate < 1.0 mg/dL
3. Time with hypophosphatemia [ Time Frame: number of days any time from baseline to week 10 ]
   time with s-phosphate < 2.0 mg/dL

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Contacts

Contact: Pharmacosmos A/S Clinical and Non-clinical Research; +4559485959; info@pharmacosmos.com

Locations

Denmark

Pharmacosmos Investigational Site; Recruiting

Silkeborg, Denmark, 8600

Sponsors and Collaborators

Pharmacosmos A/S

More Information

• Responsible Party: Pharmacosmos A/S
• ClinicalTrials.gov Identifier: NCT03466983
• Other Study ID Numbers: P-Monofer-IBD-03
• First Posted: March 15, 2018
• Last Update Posted: March 4, 2020
• Last Verified: October 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Inflammatory Bowel Diseases; Anemia, Iron-Deficiency; Hypophosphatemia; Anemia; Hematologic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Anemia, Hypochromic; Iron Metabolism Disorders; Metabolic Diseases; Phosphorus Metabolism Disorders; Iron isomaltoside 1000; Hematinics