A Multi-center, Open-label, Single Arm Study to Characterize the Pharmacokinetics and Pharmacodynamics Profile of Intravenous Ferric Carboxymaltose in Pediatric Subjects 1-17 Years Old With Iron Deficiency Anemia (IDA)
Overview
- Phase
- Phase 2
- Intervention
- Ferric Carboxymaltose (FCM)
- Conditions
- Iron Deficiency Anemia (IDA)
- Sponsor
- American Regent, Inc.
- Enrollment
- 35
- Locations
- 10
- Primary Endpoint
- Maximum Serum Concentration (Cmax)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
Ferric Carboxymaltose (FCM)
FCM at 7.5 mg/kg or 15 mg/kg to a maximum single dose of 750 mg iron, whichever is smaller
Intervention: Ferric Carboxymaltose (FCM)
Outcomes
Primary Outcomes
Maximum Serum Concentration (Cmax)
Time Frame: prior to dosing and 1, 2, 6, 12, 48 and 72 hours post dosing
Maximum observed serum concentration; obtained directly from the serum concentration-time profile.