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Trial record 78 of 380 for:    FERRIC CATION

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

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ClinicalTrials.gov Identifier: NCT02410213
Recruitment Status : Completed
First Posted : April 7, 2015
Results First Posted : November 29, 2017
Last Update Posted : November 29, 2017
Sponsor:
Information provided by (Responsible Party):
American Regent, Inc.

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.

Condition or disease Intervention/treatment Phase
Iron Deficiency Anemia (IDA) Drug: Ferric Carboxymaltose (FCM) Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Intervention Model: Sequential Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : February 19, 2015
Actual Primary Completion Date : January 22, 2017
Actual Study Completion Date : June 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron

Arm Intervention/treatment
Experimental: 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
Drug: Ferric Carboxymaltose (FCM)
Other Name: Injectafer




Primary Outcome Measures :
  1. Maximum Serum Concentration (Cmax) [ Time Frame: prior to dosing and 1, 2, 6, 12, 48 and 72 hours post dosing ]
    Maximum observed serum concentration; obtained directly from the serum concentration-time profile.



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Ages Eligible for Study:   1 Year to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 < 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02410213


Locations
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Poland
Uniwersytecki Szpital Dzieciecy w Lublinie Klinika Hematologii, Onkologii i Transplantologii Dzieciecej
Lublin, Poland, 20-093
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, Russian Federation, 194100
Sponsors and Collaborators
American Regent, Inc.
  Study Documents (Full-Text)

Documents provided by American Regent, Inc.:
Study Protocol  [PDF] October 8, 2014
Statistical Analysis Plan  [PDF] February 4, 2017


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Responsible Party: American Regent, Inc.
ClinicalTrials.gov Identifier: NCT02410213     History of Changes
Other Study ID Numbers: 1VIT13036
First Posted: April 7, 2015    Key Record Dates
Results First Posted: November 29, 2017
Last Update Posted: November 29, 2017
Last Verified: October 2017
Additional relevant MeSH terms:
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Anemia
Anemia, Iron-Deficiency
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Ferric Compounds
Hematinics