Phase 2
N=35
A Study to Characterize the PK and PD Profile of IV FCM in Pediatric Subjects 1-17 Years Old With IDA
Iron Deficiency Anemia (IDA)
Bottom Line
View on ClinicalTrials.gov: NCT02410213 ↗Enrolled (actual)
35
Serious AEs
5.7%
Results posted
Nov 2017
Primary outcome: Primary: Maximum Serum Concentration (Cmax) — 157; 310 µg/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ferric Carboxymaltose (FCM) (Drug)
- Age
- Pediatric · 1+ yrs
- Sex
- All
- Sponsor
- American Regent, Inc.
- Primary completion
- Jan 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Serum Concentration (Cmax) |
157; 310 | — |
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.
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 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 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.
Data sourced from ClinicalTrials.gov (NCT02410213). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.