CTRI/2023/01/048725
Not yet recruiting
Phase 3
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
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: D509- Iron deficiency anemia, unspecified
- Sponsor
- Armed Forces Medical College
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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 \<\= 11 g/dL
- •4\. TSAT \< 20 %
- •5\. S\-ferritin \< 100 ng/mL
- •6\. Willingness to participate and sign the informed consent form
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
Outcomes
Primary Outcomes
Not specified
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