Comparison of different types of Injectable iron in the treatment of Iron Deficiency Anemia

A phase III, randomised, single blind, comparative safety, efficacy and cost effectiveness trial of intravenous iron isomaltoside (i3R) and Ferric Carboxy Maltose (FeriumR) in subjects with iron deficiency anemia - SCIFI

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/01/048725

Enrollment

280

Registered

2023-01-04

Start date

Unknown

Completion date

Unknown

Last updated

2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: D509- Iron deficiency anemia, unspecified

Interventions

Intervention1: Iron Isomaltoside(i3): Iron isomaltoside will be administered as a single IV infusion of 1000 mg at baseline diluted in 100 mL 0.9 % sodium chloride and given over approximately 20 minu

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects having IDA are caused by nutritional and different aetiologies of blood loss such as abnormal uterine bleeding, gastrointestinal diseases, and bariatric procedures (gastric bypass operations. 2. Subjects with intolerance to oral iron 3. Hb 4. TSAT 5. S-ferritin 6. Willingness to participate and sign the informed consent form

Exclusion criteria

Exclusion criteria: 1. Known hypersensitivity reaction to any component of iron isomaltoside or FCM 2. Previous serious hypersensitivity reactions to any IV iron compounds 3. Previously randomized in a clinical trial with iron isomaltoside 4, Received an investigational drug within 30 days of screening 5. During the 10 days before screening; has been treated with IV iron 6. Erythropoiesis stimulating agent (ESA) treatment within 30 days before the screening visit 7. During the 30 days before screening or during the trial period; has or will require a surgical procedure that necessitates general anesthesia 8. Any non-viral infection 9. Required dialysis for treatment of CKD 10. Any other laboratory abnormality, medical condition, or psychiatric disorder which, in the opinion of the investigator, will put the subjectâ??s disease management at risk or may result in the subject being unable to comply with the trial requirements

Design outcomes

Primary

Measure	Time frame
To evaluate and compare the effect and cost-effectiveness of iron isomaltoside to FCM in its ability to increase Hb and Ferritin in subjects with IDA Timepoint: 4weeks, 8 weeks, 12 weeks and 24 weeks	—

Secondary

Measure	Time frame
To evaluate and compare the effect of iron isomaltoside to FCM on (a) Other relevant iron related biochemical parameters (b) Fatigue symptoms (c) Pharmacoeconomics Timepoint: 4 weeks 8 weeks 12 weeks 24 weeks	—

Countries

India

Contacts

Public ContactUday yanamandra

Armed Forces Medical College

udayj2@gmail.com8195035551

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026