Intravenous vs Oral Iron for Anemia

(IDA Trial)

Age: 18+

Sex: Female

Trial Phase: Phase 3

Sponsor: Arrowhead Regional Medical Center

Disqualifiers: Multifetal gestation, Liver/kidney disease, Infections, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: Until delivery

900 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the best way to treat iron deficiency anemia in pregnant individuals by testing two iron treatments: ferrous sulfate, taken orally, and Venofer, administered intravenously. The goal is to determine which method more effectively improves hemoglobin levels and reduces the need for blood transfusions before delivery. Pregnant individuals with low iron levels, expecting one baby, and planning to give birth at Arrowhead Regional Medical Center might be suitable candidates. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Venofer, an IV treatment for providing iron, is generally safe for most people. In one study, 223 doses were administered without any serious side effects. However, severe allergic reactions, though rare, can occur and may be life-threatening. Awareness of this risk is important. Common side effects might include low blood pressure, so careful monitoring is crucial.

Previous studies on ferrous sulfate, an oral iron supplement, indicate it is usually well-tolerated. Some individuals might experience mild stomach upset or constipation. Overall, both treatments are considered safe, but reactions can vary from person to person. Consulting a doctor before starting any treatment is essential. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the treatments for anemia in this trial because they explore two different ways to boost iron levels: orally and intravenously. Ferrous sulfate, the oral iron option, is taken every other day with citrus juice to enhance absorption, making it a convenient at-home treatment. On the other hand, Venofer, the intravenous option, delivers iron directly into the bloodstream, which can quickly replenish iron stores for those who may not absorb iron well through the gut. Unlike the standard oral supplements that take longer to work, Venofer is tailored to the patient’s needs using the Ganzoni formula, ensuring a precise dose to reach a healthy hemoglobin level more efficiently.

What evidence suggests that this trial's treatments could be effective for anemia?

This trial will compare intravenous iron with oral iron for treating anemia. Studies have shown that intravenous iron, such as Venofer, effectively treats iron deficiency anemia. Participants receiving intravenous iron may experience faster improvements in hemoglobin levels compared to those taking oral iron pills, like Ferrous sulfate. Some research suggests that intravenous iron can significantly reduce the need for blood transfusions by delivering iron directly into the bloodstream, which can be more efficient than oral supplements. Overall, intravenous iron reliably increases iron levels in people with anemia. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for pregnant individuals with iron deficiency anemia. Participants must have a confirmed diagnosis and be at a stage in their pregnancy where they can safely receive treatment. There's no mention of specific exclusion criteria provided, so it's unclear who might not qualify.

Inclusion Criteria

Ferritin level < 30 ng/mL

Plan to deliver at Arrowhead Regional Medical Center (ARMC)

I am older than 18 years.

Exclusion Criteria

Multifetal gestation

I am under 18 years old.

I do not have acute liver or kidney disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either oral iron or intravenous iron treatment for iron deficiency anemia

Until delivery

Initial visit for baseline assessment, followed by visits every 4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including hemoglobin and ferritin levels

6 weeks postpartum

Post-delivery visit for final assessment

Postpartum Monitoring

Monitoring of postpartum depression and other secondary outcomes

Up to 2 months postpartum

What Are the Treatments Tested in This Trial?

Interventions

• Ferrous sulfate
• Venofer

Trial Overview The study compares two ways to treat iron deficiency anemia in pregnancy: one group receives Venofer (an intravenous iron injection), while the other takes Ferrous sulfate (oral iron tablets). Patients are randomly chosen for either method and monitored over time to see which is more effective.

How Is the Trial Designed?

Group I: Intravenous iron Active Control 1 Intervention

Venofer 200 mg will be given every other day until the patient reaches their calculated in deficit dose. The does of IV iron will be calculated according to the Ganzoni formula: total iron dose (mg) = body weight (kg) x (target Hgb - baseline Hgb (g/dL)) × 0.24 + 500 mg.14 Our target Hgb will be 11.0 g/dL. The determination of the treatment duration and dosage will be based on the calculation of the iron deficit.

Group II: Oral iron Placebo Group 1 Intervention

Ferrous sulfate 325 mg orally every other day on an empty stomach with lemon/orange water until delivery.

Ferrous sulfate is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Ferrous sulfate for:

• Iron deficiency anemia
• Pregnancy-related anemia

Approved in European Union as Ferrous sulfate for:

• Iron deficiency anemia
• Pregnancy-related anemia

Approved in Canada as Ferrous sulfate for:

• Iron deficiency anemia
• Pregnancy-related anemia

Who Is Running the Clinical Trial?

Arrowhead Regional Medical Center

Lead Sponsor

Trials

18

Recruited

28,200+

Published Research Related to This Trial

In a study of 100 patients with iron deficiency anemia, intravenous (IV) iron sucrose significantly increased hemoglobin levels more than oral iron supplements, with hemoglobin rising to 11.66 g/dL in the IV group compared to 9.69 g/dL in the oral group by day 28.

IV iron therapy was found to be safe, with fewer adverse effects compared to oral iron; while some patients experienced arthralgia and hypotension, no cases of anaphylaxis were reported, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral versus intravenous iron therapy in iron deficiency anemia: An observational study. Das, SN., Devi, A., Mohanta, BB., et al.[2022]

Intravenous ferrous sucrose significantly increases hemoglobin levels more rapidly than oral ferrous sulfate in women with postpartum iron deficiency anemia, showing higher levels at days 5, 14, and 40 after treatment.

The study, involving 352 women with low hemoglobin and ferritin levels, found that intravenous ferrous sucrose also replenishes iron stores more quickly and is better tolerated compared to oral iron supplements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of intravenous ferrous sucrose and oral ferrous sulphate in treatment of postpartum iron deficiency anemia. El Khouly, NI.[2017]

Intravenous iron sucrose (Venofer®) is an effective treatment for iron deficiency and iron-deficiency anemia, especially in patients who cannot tolerate or respond to oral iron, and is now considered first-line therapy in conditions like end-stage kidney disease and chronic heart failure.

Iron sucrose has a strong safety profile and rapidly improves hemoglobin and iron levels, but there are concerns about substituting it with similar products due to potential differences in efficacy and safety, highlighting the complexity of its nanomedicine formulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Iron Sucrose: A Wealth of Experience in Treating Iron Deficiency. Macdougall, IC., Comin-Colet, J., Breymann, C., et al.[2023]

In a study of 150 chronic kidney disease patients, intravenous iron sucrose significantly improved serum iron, ferritin, and transferrin saturation levels compared to oral iron, indicating better absorption and effectiveness.

The IV iron group also showed a statistically significant increase in hemoglobin levels across all stages of kidney disease, while the oral iron group did not demonstrate similar improvements, highlighting the superiority of IV iron therapy for managing anemia in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Oral Versus Injectable Iron in Patients With Chronic Kidney Disease: A Two-Year Cross-Sectional Study Conducted at a Rural Teaching Hospital. Agrawal, S., Sonawane, S., Kumar, S., et al.[2022]

Intravenous iron sucrose significantly increased ferritin levels compared to oral iron sulfate at both 30 days and at delivery, indicating better iron stores replenishment in pregnant women with anemia.

Both treatments improved hemoglobin levels, but intravenous iron sucrose showed a trend towards higher birth weights, suggesting potential benefits for the baby, while being safe with no serious side effects reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Iron therapy in iron deficiency anemia in pregnancy: intravenous route versus oral route. Bayoumeu, F., Subiran-Buisset, C., Baka, NE., et al.[2022]

A review of intravenous iron formulations from 2001-2003 found that higher molecular weight iron dextran was associated with significantly more adverse drug events (ADEs) compared to lower molecular weight iron dextran, sodium ferric gluconate complex, and iron sucrose.

The overall rate of intravenous iron-related ADEs was very low at approximately 38 per million doses, with life-threatening ADEs being much less common in non-dextran formulations, highlighting their safety profile despite the high cost of preventing these events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Update on adverse drug events associated with parenteral iron. Chertow, GM., Mason, PD., Vaage-Nilsen, O., et al.[2022]

Sucrosomial® iron (SI) is an innovative oral iron formulation that offers high bioavailability and excellent gastrointestinal tolerance, making it a more effective and better-tolerated option for treating iron deficiency compared to traditional oral iron salts.

SI has shown similar effectiveness to intravenous iron treatments while presenting lower risks, suggesting it could be a preferred first-line treatment for patients who cannot tolerate or do not respond to standard iron supplements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sucrosomial&#174; Iron: A New Generation Iron for Improving Oral Supplementation. Gómez-Ramírez, S., Brilli, E., Tarantino, G., et al.[2020]

Oral iron treatments have low bioavailability (10-20%) and are often not taken correctly by patients, leading to reduced effectiveness and digestive issues.

Intravenous treatments like Venofer (hydroxide ferric saccharose) are currently the only option in France, but they are significantly more expensive; other intravenous iron products have shown similar efficacy and safety, suggesting alternatives may be available.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatments of the martial deficiencies: preparations available in France]. Ranfaing, E.[2021]

In a randomized controlled trial involving 268 pregnant women with moderate iron deficiency anemia, intravenous iron sucrose was found to be superior to oral ferrous sulfate in terms of tolerability and effectiveness in correcting anemia.

Intravenous iron sucrose led to a quicker increase in hemoglobin and serum ferritin levels without major side effects, making it a preferable treatment option for pregnant women in remote areas with limited access to healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Controlled Trial Comparing Ferrous Sulfate and Iron Sucrose in Iron Deficiency Anemia in Pregnancy. Chauhan, N., Dogra, P., Sharma, R., et al.[2023]

In a study of 128 postpartum women with anemia, those who received 600 mg of intravenous ferrous sucrose followed by oral iron showed significantly higher serum ferritin levels after 4 weeks compared to those who only received oral iron, indicating faster replenishment of iron stores.

The intravenous iron group also reported significantly lower fatigue scores at 4, 8, and 12 weeks, suggesting an improvement in quality of life, although overall quality of life as measured by the SF-36 did not show significant differences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A 12-week randomised study comparing intravenous iron sucrose versus oral ferrous sulphate for treatment of postpartum anemia. Westad, S., Backe, B., Salvesen, KA., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7467495/

Iron Sucrose: A Wealth of Experience in Treating ... As summarized in Table 2, studies have consistently reported that iron sucrose is an effective treatment for iron deficiency/iron-deficiency anemia in patients ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7282824/

Iron kinetics following treatment with sucroferric ... Data from clinical studies indicate differences in the level of iron absorption from SFOH and FC. A Phase 1 study of SFOH demonstrated low iron ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2468024925000543

Systematic Review of the Effects of Iron on Cardiovascular ... Iron therapy may reduce the risk of heart failure and cardiovascular death in patients with CKD. Randomized trials evaluating the effects of iron on clinical ...

4. velphorohcp.com velphorohcp.com/content/dam/velphorohcp/documents/coyne_2017.pdf

Real-world effectiveness of sucroferric oxyhydroxide in ... We sought to assess the real-world effectiveness of sucroferric oxyhydroxide. (SO), an iron-based phosphate binder (PB), in control of serum ...

5. academic.oup.com academic.oup.com/ndt/article/30/6/1037/2324877

Long-term effects of the iron-based phosphate binder ... In Phase I clinical studies, sucroferric oxyhydroxide was well tolerated and associated with minimal gastrointestinal (GI) iron absorption [13].

6. venofer.com venofer.com/safety

Venofer® Safety Profile Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2670525/

Safety Issues With Intravenous Iron Products in the ... Results showed no serious adverse drug reactions after a total of 223 doses of iron sucrose (184 doses by intravenous push, 39 doses by intravenous infusion).

8. reference.medscape.com reference.medscape.com/drug/venofer-iron-sucrose-342162

Venofer (iron sucrose) dosing, indications, interactions, ... Warnings ; Contraindications. Hypersensitivity. Anemia not caused by iron deficiency. Iron overload ; Cautions. Risk of hypotension. Withhold therapy in tissue ...

9. mayoclinic.org mayoclinic.org/drugs-supplements/iron-sucrose-intravenous-route/description/drg-20075836

Iron sucrose (intravenous route) - Side effects & uses This condition is called iron deficiency (iron shortage) or iron deficiency anemia. ... Safety and efficacy have not been established.

10. medsafe.govt.nz medsafe.govt.nz/profs/datasheet/v/venoferinf.pdf

Venofer® 20 mg/mL solution for injection. The use of Venofer is contraindicated in of the following conditions: • Anaemia not caused by iron deficiency. • Iron overload or disturbances in utilisation of ...