A Study to Characterize the PK and PD Profile of IV FCM in Pediatric Subjects 1-17 Years Old With IDA
- Conditions
- Iron Deficiency Anemia (IDA)
- Interventions
- Drug: Ferric Carboxymaltose (FCM)
- Registration Number
- NCT02410213
- Lead Sponsor
- American Regent, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Ferric Carboxymaltose (FCM) 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
- Primary Outcome Measures
Name Time Method Maximum Serum Concentration (Cmax) 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (10)
Indywidualna Specjalistyczna Praktyka lekarska z siedzibą w Rzeszowie
🇵🇱Rzeszów, Poland
Uniwersytecki Szpital Dziecięcy w Krakowie, Oddział Pediatrii i Gastroenterologii (V)
🇵🇱Kraków, Poland
State Budgetary Educational Institution of Higher Professional Education "Ryazan State Medical University named after academician I.P. Pavlov" of the Ministry of Health of the Russian Federation
🇷🇺Ryazan', Russian Federation
Szpital Uniwersytecki Katedra i Klinika Pediatrii, Hematologii i Onkologii
🇵🇱Bydgoszcz, Poland
Zespół Opieki Zdrowotnej w Dębicy z siedzibą w Dębicy , Oddział Dziecięcy
🇵🇱Dębica, Poland
Klinika Hematologii, Onkologii i Transplantologii Dziecięcej Uniwersytecki Szpital Dziecięcy w Lublinie
🇵🇱Lublin, Poland
Klinika Pediatrii, Hematologii i Onkologii Dziecięcej
🇵🇱Szczecin, Poland
State Educational Institution of Higher Professional Education Saint Petersburg State Pediatric Medical Acamy of Ministry of Health and Social Development of the Russian Federation
🇷🇺Saint Petersburg, Russian Federation
Oddział Ogólnopediatryczny; Uniwersytecki Szpital Dziecięcy w Lublinie
🇵🇱Lublin, Poland
Klinika Gastroenterologii, Hepatologii, Zaburzeń Odżywiania i Pediatrii
🇵🇱Warszawa, Poland