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Iron Replacement Therapy

Intravenous Iron Therapy for Iron Deficiency in Pregnancy

Phase 3

Recruiting

Led By Ryan Lett, MD, FRCPC

Research Sponsored by Saskatchewan Health Authority - Regina Area

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years of age and over

Pregnancy with Gestational age ≥13 weeks

Must not have

Active acute or chronic infections

Heart disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up collected at 6 weeks postpartum

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a new intravenous iron replacement drug to see if it is as effective as other formulations of IV iron, with the goal of reducing maternal and neonatal risks.

Who is the study for?

This trial is for pregnant women over 18 with moderate to severe iron deficiency anemia, defined by specific blood test results. They must be at least 13 weeks into their pregnancy and willing to attend all treatment and follow-up appointments. Women with kidney or heart disease, certain infections, iron utilization disorders, recent IV iron or transfusions, multiple pregnancies, serious allergies or other significant health issues are excluded.

What is being tested?

The study compares two intravenous (IV) iron treatments: ferric derisomaltose (iron isomaltoside) versus the standard treatment of iron sucrose in pregnant women with iron deficiency anemia. The aim is to correct IDA effectively with fewer healthcare visits and improve maternal and neonatal health outcomes.

What are the potential side effects?

Potential side effects may include allergic reactions to the IV components, which could range from mild skin reactions to more severe responses. Other common side effects of IV iron treatments can include headache, nausea, high blood pressure episodes during infusion, muscle cramps or joint pains.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am pregnant and in my second trimester or later.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I currently have an active infection.

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I have a heart condition.

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I have severe liver damage or active hepatitis.

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I have received IV iron or a blood transfusion in the last 4 weeks.

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I have a history of anemia not caused by iron deficiency.

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I have a condition affecting how my body uses iron.

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I have asthma or another lung condition that needs daily treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ collected at delivery admission survey

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~collected at delivery admission survey

This trial's timeline: 3 weeks for screening, Varies for treatment, and collected at delivery admission survey for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Correction of anemia

Secondary study objectives

Changes in Participant's Mental Health and Physical Well-Being

Comparison of participant's pregnancy related symptoms- subjective measure

Convenience/barriers of IV iron appointment(s)- subjective measure

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Active Control

Group I: Iron SucroseActive Control1 Intervention

Route: Intravenous Dosage: 100 mg/mL (maximum 300 mg per dose) Frequency: up to 3 doses per week or 1000 mg per week maximum Duration: until iron needs reached by simplified table

Group II: Iron Isomaltoside/ferric derisomaltoseActive Control1 Intervention

route: intravenous Dosage: 1000-1500 mg (100mg/mL), max dose 20mg/kg Frequency: max dose 1000 mg, if further doses required, must receive dosage divided Duration: one infusion or two infusions (dose dependent)

0 / 9Eligibility criteria met