Multicenter Randomized Active-controlled Study to Investigate Efficacy & Safety of IV FCM in Pediatric Patients With IDA

• Status: Completed
• Trial end date: 2021-01-29
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to demonstrate the efficacy and safety of intravenous ferric carboxymaltose (FCM), compared to oral iron, in pediatric participants who have iron deficiency anemia.

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

Details

• Lead Sponsor: American Regent, Inc.; Luitpold Pharmaceuticals
• Treatments: Ferric Compounds; Iron

Criteria

Inclusion Criteria:

1. Male or female participants 1 to 17 years of age with assent to participation and his/her parent or guardian is willing and able to sign the informed consent approved by the Independent Review Board / Ethics Committee.

2. Screening Hgb <11 g/dL.

3. Screening ferritin ≤300 ng/mL and transferrin saturation (TSAT) <30%.

4. Participants must have a documented history of an inadequate response to any oral iron therapy for at least 8 weeks (56 days) prior to randomization.

5. For participants who are receiving an erythropoietin stimulating agent (ESA): stable ESA therapy (+/- 20% of current dose) for at least 8 weeks prior to the qualifying screening visit and no ESA dosing or product changes anticipated for the length of the trial.

6. Participants undergoing treatment for inflammatory bowel disease (IBD) must be on stable therapy for at least 8 weeks prior to consent.

Exclusion Criteria:

1. Known history of hypersensitivity reaction to any component of FCM.

2. Previous randomization and treatment in this study or any other clinical study of FCM or VIT-45.

3. History of acquired iron overload, hemochromatosis, or other iron accumulation disorders.

4. Chronic kidney disease participants on hemodialysis.

5. History of significant diseases of the liver, hematopoietic system, cardiovascular system, psychiatric disorder, or other conditions which, on the opinion of the investigator, may place a subject at added risk for participation in the study.

6. Any existing non-viral infection.

7. Known history of positive hepatitis B antigen (HBsAg) or hepatitis C viral antibody (HCV) with evidence of active hepatitis.

8. Known history of positive HIV-1/HIV-2 antibodies (anti-HIV).

9. Anemia due to reasons other than iron deficiency (e.g., hemoglobinopathy and vitamin B12 or folic acid deficiency) that has not been corrected.

10. Intravenous iron and /or blood transfusion in the 4 weeks prior to consent.

11. Administration and / or use of an investigational product (drug or device) within 30 days of screening.

12. Alcohol or drug abuse within the past six months.

13. Female participant who is pregnant or lactating, or sexually active female who are of childbearing potential not willing to use an acceptable form of contraceptive precautions during the study.

14. Unable to comply with study procedures and assessments