NCT02410213

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2015

Geographic Reach
2 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 19, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 27, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 7, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
6 months until next milestone

Results Posted

Study results publicly available

November 29, 2017

Completed
Last Updated

July 25, 2022

Status Verified

July 1, 2022

Enrollment Period

1.9 years

First QC Date

March 27, 2015

Results QC Date

September 22, 2017

Last Update Submit

July 21, 2022

Conditions

Iron Deficiency Anemia (IDA)

Outcome Measures

Primary Outcomes (1)

  • Maximum Serum Concentration (Cmax)

    Maximum observed serum concentration; obtained directly from the serum concentration-time profile.

    prior to dosing and 1, 2, 6, 12, 48 and 72 hours post dosing

Study Arms (1)

Ferric Carboxymaltose (FCM)

EXPERIMENTAL

FCM at 7.5 mg/kg or 15 mg/kg to a maximum single dose of 750 mg iron, whichever is smaller

Drug: Ferric Carboxymaltose (FCM)

Interventions

Ferric Carboxymaltose (FCM)DRUG
Also known as: Injectafer
Ferric Carboxymaltose (FCM)

Eligibility Criteria

Age1 Year - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Szpital Uniwersytecki Katedra i Klinika Pediatrii, Hematologii i Onkologii

Bydgoszcz, 85-094, Poland

Location

Zespół Opieki Zdrowotnej w Dębicy z siedzibą w Dębicy , Oddział Dziecięcy

Dębica, 39-200, Poland

Location

Uniwersytecki Szpital Dziecięcy w Krakowie, Oddział Pediatrii i Gastroenterologii (V)

Krakow, 30-663, Poland

Location

Klinika Hematologii, Onkologii i Transplantologii Dziecięcej Uniwersytecki Szpital Dziecięcy w Lublinie

Lublin, 20-093, Poland

Location

Oddział Ogólnopediatryczny; Uniwersytecki Szpital Dziecięcy w Lublinie

Lublin, 20-093, Poland

Location

Indywidualna Specjalistyczna Praktyka lekarska z siedzibą w Rzeszowie

Rzeszów, 35-302, Poland

Location

Klinika Pediatrii, Hematologii i Onkologii Dziecięcej

Szczecin, 71-252, Poland

Location

Klinika Gastroenterologii, Hepatologii, Zaburzeń Odżywiania i Pediatrii

Warsaw, 04-730, Poland

Location

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, 390029, Russia

Location

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, 194100, Russia

Location

Related Publications (1)

  • Korczowski B, Farrell C, Falone M, Blackman N, Rodgers T. Safety, pharmacokinetics, and pharmacodynamics of intravenous ferric carboxymaltose in children with iron deficiency anemia. Pediatr Res. 2023 Oct;94(4):1547-1554. doi: 10.1038/s41390-023-02644-9. Epub 2023 May 19.

    PMID: 37208431DERIVED

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

ferric carboxymaltose

Condition Hierarchy (Ancestors)

Anemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Results Point of Contact

Title
Angelia Butcher
Organization
Luitpold Pharmaceuticals, Inc.
abutcher@lpicrd.com
610-650-4200

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: 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.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2015

First Posted

April 7, 2015

Study Start

February 19, 2015

Primary Completion

January 22, 2017

Study Completion

June 1, 2017

Last Updated

July 25, 2022

Results First Posted

November 29, 2017

Record last verified: 2022-07

Locations

RU(2)PL(8)