Clinical trial NCT03188445: Intravenous Iron Isomaltoside Versus Oral Iron Supplementation for Treatment of Iron Deficiency in Pregnancy.
Official title: Intravenous Iron Isomaltoside Versus Oral Iron Supplementation for Treatment of Iron Deficiency in Pregnancy: a Randomised, Comparative, Open-label Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Iron Deficiency Anemia of Pregnancy
Lead sponsor: Pharmacosmos A/S
Sponsor class: INDUSTRY
First posted: 2017-06-15
Enrollment: 201
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The primary outcome measure is the achievement of an hemoglobin equal or above 11 g/dL
timeFrame: from baseline to 18 weeks after treatment
Secondary outcomes:
measure: Achievement of an hemoglobin equal to or above 11 g/dL
timeFrame: T=3 weeks, T=6 weeks, T=12 weeks, and T=18 weeks
measure: Change in iron biomarkers
timeFrame: From baseline to T=3 weeks, T=6 weeks, T=12 weeks, and T=18 weeks
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Phamacosmos Investigational site
state: Sjaeland
Study officials:
affiliation: Pharmacosmos A/S
name: Pharmacosmos A/S Clinical and Non-clinical Research
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.