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

NCT ID: NCT03188445

Last Updated: 2020-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 201 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-11
• Study Completion Date: 2020-08-18

Brief Summary

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

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.

Conditions

Iron Deficiency Anemia of Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IV administration

Iron isomaltoside (Monofer) Administered iv

Group Type: EXPERIMENTAL

Iron Isomaltoside 1000

Intervention Type: DRUG

Administered iv

Oral administration

Ferrous fumarate with ascorbic acid Administered oral

Group Type: ACTIVE_COMPARATOR

ferrous fumarate with ascorbic acid

Intervention Type: DRUG

Oral administration

Interventions

Iron Isomaltoside 1000

Administered iv

Intervention Type: DRUG

ferrous fumarate with ascorbic acid

Oral administration

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Pharmacosmos A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pharmacosmos A/S Clinical and Non-clinical Research

Role: STUDY_DIRECTOR

Pharmacosmos A/S

Locations

Phamacosmos Investigational site

Hvidovre, Sjaeland, Denmark

Countries

Denmark

References

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. 2023 Oct;308(4):1165-1173. doi: 10.1007/s00404-022-06768-x. Epub 2022 Sep 15.

Reference Type: DERIVED

PMID: 36107229 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32843079 (View on PubMed)

Other Identifiers

P-Monofer-PREG-01

Identifier Type: -

Identifier Source: org_study_id