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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-19

Study Completion Date

2017-06-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Iron Deficiency Anemia (IDA)

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Eligible subjects were enrolled sequentially in Cohort 1 (FCM at 7.5 mg/kg with a maximum single dose of 750 mg) and Cohort 2 (FCM at 15 mg/kg with a maximum single dose of 750 mg). Enrollment in Cohort 2 was initiated only after all subjects in Cohort 1 completed 4 weeks of therapy and a Data and Safety Monitoring Board (DSMB) approved continuation.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Ferric Carboxymaltose (FCM)

Intervention Type DRUG

Interventions

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Ferric Carboxymaltose (FCM)

Intervention Type DRUG

Other Intervention Names

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Injectafer

Eligibility Criteria

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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.

Minimum Eligible Age

1 Year

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No