Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose for the Treatment of Iron Deficiency Anemia (IDA)

• Status: Completed
• Trial end date: 2018-03-28
• Target enrollment: 0
• Participant gender: All

Summary

Evaluate safety and efficacy of iron isomaltoside/ferric derisomaltose (Monofer®/Monoferric®) compared with iron sucrose (Venofer®), in subjects diagnosed with IDA.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pharmacosmos A/S
• Treatments: Ferric Compounds; Ferric Oxide, Saccharated; Iron; Iron isomaltoside 1000

Criteria

Inclusion criteria includes:

1. Men or women ≥ 18 years

2. Subjects having IDA caused by different etiologies

3. Subjects with intolerance to oral iron therapy or a need for rapid repletion of iron stores:

4. Haemoglobin (Hb) ≤ 11 g/dL

5. Transferrin Saturation (TSAT) < 20 %

6. S-ferritin < 100 ng/mL

7. Willingness to participate and signing the informed consent form

Exclusion Criteria includes :

1. Anemia predominantly caused by factors other than IDA

2. Hemochromatosis or other iron storage disorders

3. Previous serious hypersensitivity reactions to any IV iron compound

4. Erythropoiesis stimulating agent (ESA) treatment

5. Prior to screening or during the trial period; has or will be treated with a red blood cell transfusion, radiotherapy, and/or chemotherapy

6. Will require a surgical procedure that necessitated general anesthesia prior to screening or during the trial period

7. Alanine aminotransferase and/or aspartate aminotransferase > 3 times upper limit of normal

8. Required dialysis for treatment of chronic kidney disease (CKD)

9. Alcohol or drug abuse within the past 6 months

10. Pregnant or nursing women