Intravenous Iron Isomaltoside Versus Oral Iron Supplementation for Treatment of Iron Deficiency in Pregnancy.

Intravenous Iron Isomaltoside Versus Oral Iron Supplementation for Treatment of Iron Deficiency in Pregnancy: a Randomised, Comparative, Open-label Trial

Intravenous iron isomaltoside versus oral iron supplementation for treatment of iron deficiency in pregnancy

Study Overview

• Status: Completed
• Conditions: Iron Deficiency Anemia of Pregnancy
• Intervention / Treatment: Drug: Iron Isomaltoside 1000; Drug: ferrous fumarate with ascorbic acid

Detailed Description

Iron deficiency (ID) in pregnant women can cause iron deficiency anaemia (IDA). ID is defined by low iron stores, measured by a low level of s-ferritin. Iron is essential for the synthesis of haemoglobin (Hb). Anaemia is defined by a low Hb level (<11.0 g/dL in 1st trimester, <10.5 g/dL in 2nd, and <10.5 - 11.0 g/dL in 3rd trimesters).

In Danish pregnant women, who do not take iron supplementation approximately 50 % have ID and 21 % have IDA. According to WHO anaemia, defined as Hb <11.0 g/dL, regardless the cause is estimated to occur in 24 % of Danish pregnant women.

This trial is designed to evaluate and compare the effect of IV iron isomaltoside to a fixed dose of oral iron administered as tablet ferrous fumarate with ascorbic acid as correction of IDA in pregnant women after 4 weeks of standard treatment.

• Study Type: Interventional
• Enrollment (Actual): 201
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Sjaeland
    • Hvidovre, Sjaeland, Denmark
      • Phamacosmos 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: Female

Description

Inclusion Criteria:

1. Women aged ≥18 years
2. Pregnancy at GA 14+0 - 19+0
3. Ferritin <30 μg/L after 4 weeks of standard treatment in a clinical setting
4. Willingness to participate and attend all planned follow-up visits, and signing the in-formed consent form

Exclusion Criteria:

1. History of anaemia caused by e.g. thalassemia, hypersplenism or haemolytic anaemia (known haematologic disorder other than iron deficiency)
2. Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis)
3. Drug hypersensitivity (i.e. previous hypersensitivity to IV iron)
4. Known hypersensitivity to any excipients in the investigational drug products
5. History of active asthma within the last 5 years
6. History of multiple allergies
7. Known decompensated liver cirrhosis or active hepatitis
8. Active acute or chronic infections (assessed by clinical judgement)
9. Rheumatoid arthritis with symptoms or signs of active inflammation
10. Treated with IV iron products or blood transfusion within 4 weeks prior to inclusion
11. Treated with erythropoietin (EPO) within 4 weeks prior to inclusion
12. Participation in any other interventional trial where the trial drug has not passed 5 half-lives prior to inclusion
13. Any other medical condition that, in the opinion of the Investigator, may cause the subject to be unsuitable for the completion of the trial or place the subject at potential risk from being in the trial
14. Meeting RBC-transfusion criteria (Hb ≤6.9 g/dL= 4.3 mmol/L with intolerable symptoms of anaemia like severe palpitations, severe dizziness, shortness of breath at rest or syncope or an Hb ≤6.4 g/dL (4.0 mmol/L) without intolerable symptoms of anaemia)
15. Multiple pregnancies
16. Inability to read and understand the Danish language

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IV administration; Iron isomaltoside (Monofer) Administered iv	Drug: Iron Isomaltoside 1000; Administered iv
Active Comparator: Oral administration; Ferrous fumarate with ascorbic acid Administered oral	Drug: ferrous fumarate with ascorbic acid; Oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary outcome measure is the achievement of an hemoglobin equal or above 11 g/dL	from baseline to 18 weeks after treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Achievement of an hemoglobin equal to or above 11 g/dL	T=3 weeks, T=6 weeks, T=12 weeks, and T=18 weeks
Change in iron biomarkers	From baseline to T=3 weeks, T=6 weeks, T=12 weeks, and T=18 weeks

Collaborators and Investigators

• Sponsor: Pharmacosmos A/S

Publications and helpful links

General Publications

• Hansen R, Sommer VM, Pinborg A, Krebs L, Thomsen LL, Moos T, Holm C. Intravenous ferric derisomaltose versus oral iron for persistent iron deficient pregnant women: a randomised controlled trial. Arch Gynecol Obstet. 2022 Sep 15. doi: 10.1007/s00404-022-06768-x. Online ahead of print.
• Markova V, Hansen R, Thomsen LL, Pinborg A, Moos T, Holm C. Intravenous iron isomaltoside versus oral iron supplementation for treatment of iron deficiency in pregnancy: protocol for a randomised, comparative, open-label trial. Trials. 2020 Aug 26;21(1):742. doi: 10.1186/s13063-020-04637-z.

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2017
• Primary Completion (Actual): June 26, 2020
• Study Completion (Actual): August 18, 2020

Study Registration Dates

• First Submitted: June 13, 2017
• First Submitted That Met QC Criteria: June 14, 2017
• First Posted (Actual): June 15, 2017

Study Record Updates

• Last Update Posted (Actual): November 13, 2020
• Last Update Submitted That Met QC Criteria: November 11, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Anemia, Hypochromic; Anemia; Iron Metabolism Disorders; Anemia, Iron-Deficiency; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Trace Elements; Micronutrients; Vitamins; Antioxidants; Hematinics; Ferrous fumarate; Ascorbic Acid; Iron isomaltoside 1000
• Other Study ID Numbers: P-Monofer-PREG-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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