Iron Deficiency Anemia (IDA) MedDRA version: 19.0 Level: LLT Classification code 10022974 Term: Iron deficiency anemia System Organ Class: 100000004851
Conditions
Interventions
Trade Name: FERINJECT®
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: FERRIC CARBOXYMALTOSE
CAS Number: 9007-72-1
Concentration unit: mg/ml milligram(s)/millilitre
Concentra
Sponsors
Luitpold Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 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. 2. Screening TSAT 8 weeks prior to the qualifying screening visit and no ESA dosing or product changes anticipated for the length of the trial. Are the trial subjects under 18? yes Number of subjects for this age range: 32 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity reaction to any component of Ferric Carboxymaltose. 2. Subject previously randomized and treated in this study or any other clinical study of Ferric Carboxymaltose (FCM, VIT-45). 3. Body mass index (BMI) = 5th percentile for age (see APPENDIX 2) 4. Male or Female subject 1 year of age weighing 300 ng/mL. 8. 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. 9. Any active infection. 10. Known positive hepatitis B antigen (HBsAg) or hepatitis C viral antibody (HCV) with evidence of active hepatitis. 11. Known positive HIV-1/HIV-2 antibodies (anti-HIV). 12. Anemia due to reasons other than iron deficiency (i.e. hemoglobinopathy). Subjects treated with vitamin B12 or folic acid deficiency are permitted. 13. Intravenous iron and /or blood transfusion in the 4 weeks prior to screening. 14. Immunosuppressive therapy that may lead to anemia (i.e. cyclophosphamide, azathioprine, mycophenolate mofetil). Note steroid therapy is permitted. 15. Administration and / or use of an investigational product (drug or device) within 30 days of screening. 16. Alcohol or drug abuse within the past six months. 17. Female subject 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. 18. Subject is unable to comply with study assessments.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: N/A;Timepoint(s) of evaluation of this end point: Blood samples for PK/PD will be assessed immediately prior to Ferric Carboxymaltose dosing on Day 0, at 1, 2, 6, 12, 24, 48 hours and at 72 hours. Safety assessments, including vital signs and adverse events, will be assessed starting on Day 0 at the time of Ferric Carboxymaltose dosing through Day 35.;Main Objective: The primary objectives of this study are to characterize the pharmacokinetics and determine appropriate dosing and safety of Ferric Carboxymaltose for the pediatric population suffering from iron deficiency (ID) with anemia.;Primary end point(s): Clinical endpoints include: - Efficacy: change from baseline to each scheduled visit for hemoglobin, ferritin, and TSAT. - Safety: - Proportion of subjects reporting treatment-emergent adverse events, overall and related, by SOC and preferred term - Subjects reporting treatment-emergent serious adverse events, overall and related, will be identified The primary and secondary pharmacokinetic parameters will be determined for each subject as appropriate, based on serum concentration. - Mean change from baseline to each scheduled visit for clinical laboratory values - Incidence of treatment-emergent potentially clinically significant (PCS) clinical laboratory values - Incidence of treatment-emergent PCS vital sign values. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A | — |
Countries
Poland, Russian Federation
Contacts
Public ContactClinical Trial Information
Luitpold Pharmaceuticals, Inc.
Outcome results
None listed