A Study to Characterize the PK and PD Profile of IV FCM in Pediatric Subjects 1-17 Years Old With IDA

American Regent

Status and phase

Completed

Phase 2

Conditions

Iron Deficiency Anemia (IDA)

Treatments

Drug: Ferric Carboxymaltose (FCM)

Study type

Interventional

Funder types

Industry

Identifiers

NCT02410213

1VIT13036

Details and patient eligibility

About

This is a Phase II, open-label, non-randomized, multi-center, single arm study to characterize the pharmacokinetic and pharmacodynamics (PK/PD) profile of Ferric Carboxymaltose dosing in pediatric subjects with IDA after receiving either a 7.5 mg/kg or 15 mg/kg dose of Ferric Carboxymaltose.

Full description

Enrollment

35 patients

Sex

All

Ages

1 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female subjects 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.
Screening TSAT < 20%
Screening Hemoglobin < 11 g/dL
For subjects who are receiving an erythropoietin stimulating agent (ESA): stable ESA therapy (+/- 20% of current dose) for > 8 weeks prior to the qualifying screening visit and no ESA dosing or product changes anticipated for the length of the trial

Exclusion criteria

Known hypersensitivity reaction to any component of Ferric Carboxymaltose.
Subject previously randomized and treated in this study or any other clinical study of Ferric Carboxymaltose (FCM or VIT-45).
Body mass index (BMI) ≤ 5th percentile for age (see APPENDIX 2)
Male or Female subject 1 year of age weighing < 12kg.
History of acquired iron overload, hemochromatosis or other iron accumulation disorders.
Chronic kidney disease subjects on hemodialysis.
Screening Ferritin level > 300ng/mL
Subjects with significant severe diseases of the liver, hemopoietic system, cardiovascular system, psychiatric disorder or other conditions which on the opinion of the investigator may place a subject at added risk.
Any active infection.
Known positive hepatitis B antigen (HBsAg) or hepatitis C viral antibody (HCV) with evidence of active hepatitis.
Known positive HIV-1/HIV-2 antibodies (anti-HIV).
Anemia due to reasons other than iron deficiency (i.e. hemoglobinopathy). Subjects treated with vitamin B12 or folic acid deficiency are permitted.
Intravenous iron and /or blood transfusion in the 4 weeks prior to screening.
Immunosuppressive therapy that may lead to anemia (i.e. cyclophosphamide, azathioprine, mycophenolate mofetil). Note steroid therapy is permitted.
Administration and / or use of an investigational product (drug or device) within 30 days of screening.
Alcohol or drug abuse within the past six months.
Female subjects who are 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.
Subject is unable to comply with study assessments.