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
Primary Purpose
IBD
Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Iron Isomaltoside
Ferric Carboxymaltose
Sponsored by
About this trial
This is an interventional treatment trial for IBD
Eligibility 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.
Sites / Locations
- Pharmacosmos Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Iron Isomaltoside
Ferric Carboxymaltose
Arm Description
Iron Isomaltoside (Monofer) administered IV
Ferric Carboxymaltose (Injectafer) administered IV
Outcomes
Primary Outcome Measures
Incidence of hypophosphatemia
s-phosphate < 2 mg/dL
Secondary Outcome Measures
Incidence of hypophosphatemia
s-phosphate < 2 mg/dL
Incidence of s-phosphate < 1.0 mg/dL
s-phosphate < 1.0 mg/dL
Time with hypophosphatemia
time with s-phosphate < 2.0 mg/dL
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03466983
Brief Title
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
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
May 23, 2018 (Actual)
Primary Completion Date
May 25, 2020 (Actual)
Study Completion Date
May 25, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pharmacosmos A/S
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IBD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
double-blinded
Allocation
Randomized
Enrollment
97 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Iron Isomaltoside
Arm Type
Experimental
Arm Description
Iron Isomaltoside (Monofer) administered IV
Arm Title
Ferric Carboxymaltose
Arm Type
Active Comparator
Arm Description
Ferric Carboxymaltose (Injectafer) administered IV
Intervention Type
Drug
Intervention Name(s)
Iron Isomaltoside
Other Intervention Name(s)
Monofer
Intervention Description
administered IV
Intervention Type
Drug
Intervention Name(s)
Ferric Carboxymaltose
Other Intervention Name(s)
Ferinject
Intervention Description
administered IV
Primary Outcome Measure Information:
Title
Incidence of hypophosphatemia
Description
s-phosphate < 2 mg/dL
Time Frame
any time from baseline to day 35
Secondary Outcome Measure Information:
Title
Incidence of hypophosphatemia
Description
s-phosphate < 2 mg/dL
Time Frame
any time from baseline to week 10
Title
Incidence of s-phosphate < 1.0 mg/dL
Description
s-phosphate < 1.0 mg/dL
Time Frame
any time from baseline to day 35
Title
Time with hypophosphatemia
Description
time with s-phosphate < 2.0 mg/dL
Time Frame
number of days any time from baseline to week 10
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Pharmacosmos Investigational Site
City
Silkeborg
ZIP/Postal Code
8600
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
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
We'll reach out to this number within 24 hrs