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) Clinical Trial

Official title:

A Multi-center, Open-label, Single Arm Study to Characterize the Pharmacokinetics and Pharmacodynamics Profile of Intravenous Ferric Carboxymaltose in Pediatric Subjects 1-17 Years Old With Iron Deficiency Anemia (IDA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02410213
• Other study ID #: 1VIT13036
• Status: Completed
• Phase: Phase 2
• Start date: February 19, 2015
• Est. completion date: June 1, 2017

Study information

• Verified date: July 2022
• Source: American Regent, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: June 1, 2017
• Est. primary completion date: January 22, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Iron Deficiency Anemia (IDA)

Intervention

Drug:
• Ferric Carboxymaltose (FCM)

Locations

Country	Name	City	State
Poland	Szpital Uniwersytecki Katedra i Klinika Pediatrii, Hematologii i Onkologii	Bydgoszcz
Poland	Zespól Opieki Zdrowotnej w Debicy z siedziba w Debicy , Oddzial Dzieciecy	Debica
Poland	Uniwersytecki Szpital Dzieciecy w Krakowie, Oddzial Pediatrii i Gastroenterologii (V)	Kraków
Poland	Klinika Hematologii, Onkologii i Transplantologii Dzieciecej Uniwersytecki Szpital Dzieciecy w Lublinie	Lublin
Poland	Oddzial Ogólnopediatryczny; Uniwersytecki Szpital Dzieciecy w Lublinie	Lublin
Poland	Indywidualna Specjalistyczna Praktyka lekarska z siedziba w Rzeszowie	Rzeszów
Poland	Klinika Pediatrii, Hematologii i Onkologii Dzieciecej	Szczecin
Poland	Klinika Gastroenterologii, Hepatologii, Zaburzen Odzywiania i Pediatrii	Warszawa
Russian Federation	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	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

Sponsors (1)

Lead Sponsor	Collaborator
American Regent, Inc.

Countries where clinical trial is conducted

Poland,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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