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

Phase 3

Conditions: Health Condition 1: D509- Iron deficiency anemia, unspecified

Registration Number: CTRI/2023/01/048725

Lead Sponsor: Armed Forces Medical College

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 <br/ ><br> <br/ ><br>Timepoint: 4weeks, 8 weeks, 12 weeks and 24 weeks

Secondary Outcome Measures

Name	Time	Method
To evaluate and compare the effect of iron isomaltoside to FCM on (a) Other relevant iron related biochemical parameters (b) Fatigue symptoms (c) Pharmacoeconomics <br/ ><br>Timepoint: 4 weeks <br/ ><br>8 weeks <br/ ><br>12 weeks <br/ ><br>24 weeks