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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.

Study Type Interventional
Study Design Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Iron Deficiency Anemia (IDA)
Intervention Drug: Ferric Carboxymaltose (FCM)
Enrollment 35
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cohort 1: Ferric Carboxymaltose (FCM) 7.5 mg/kg Cohort 2: Ferric Carboxymaltose (FCM) 15 mg/kg
Hide Arm/Group Description

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

Ferric Carboxymaltose (FCM)

FCM at 15mg/kg to a maximum single dose of 750mg iron, whichever is smaller
Period Title: Overall Study
Started 16 19
Completed 16 19
Not Completed 0 0
Arm/Group Title Ferric Carboxymaltose (FCM)
Hide Arm/Group Description

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

Ferric Carboxymaltose (FCM)

Overall Number of Baseline Participants 35
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Cohort 1 (FCM at 7.5 mg/kg to a maximum of 750mg) Number Analyzed 16 participants
9.1  (6.13)
Cohort 2 (FCM at 15 mg/kg to a maximum of 750mg) Number Analyzed 19 participants
10.3  (5.77)
[1]
Measure Analysis Population Description: Eligible subjects were enrolled sequentially in Cohort 1 or Cohort 2, for a total of 35 subjects.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Cohort 1 (FCM at 7.5 mg/kg to a maximum of 750mg) Number Analyzed 16 participants
Female
10
  62.5%
Male
6
  37.5%
Cohort 2 (FCM at 15 mg/kg to a maximum of 750mg Number Analyzed 19 participants
Female
9
  47.4%
Male
10
  52.6%
[1]
Measure Analysis Population Description: Eligible subjects were enrolled sequentially in Cohort 1 or Cohort 2, for a total of 35 subjects.
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
35
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Poland Number Analyzed 35 participants
30
Russia Number Analyzed 35 participants
5
1.Primary Outcome
Title Maximum Serum Concentration (Cmax)
Hide Description Maximum observed serum concentration; obtained directly from the serum concentration-time profile.
Time Frame prior to dosing and 1, 2, 6, 12, 48 and 72 hours post dosing
Hide Outcome Measure Data
Hide Analysis Population Description
In Cohort 1, pharmacokinetic parameter values are excluded for one subject due to anomalous and consistently high concentrations, and for one subject due to missing concentration data at 1 and 2 hours post-dose.
Arm/Group Title Cohort 1: Ferric Carboxymaltose (FCM) 7.5 mg Cohort 2: Ferric Carboxymaltose (FCM) 15 mg/kg
Hide Arm/Group Description:

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

Ferric Carboxymaltose (FCM)

FCM at 15 mg/kg to a maximum single dose of 750 mg iron, whichever is smaller
Overall Number of Participants Analyzed 14 19
Mean (Standard Deviation)
Unit of Measure: µg/mL
157  (33.8) 310  (13.9)
Time Frame Initial treatment with study drug through completion of day 35 (28 days post-dose for subjects who early terminated from the study).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cohort 1: Ferric Carboxymaltose (FCM) 7.5 mg/kg Cohort 2: Ferric Carboxymaltose (FCM) 15 mg/kg
Hide Arm/Group Description

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

Ferric Carboxymaltose (FCM)

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

Ferric Carboxymaltose (FCM)

All-Cause Mortality
Cohort 1: Ferric Carboxymaltose (FCM) 7.5 mg/kg Cohort 2: Ferric Carboxymaltose (FCM) 15 mg/kg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)      0/19 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Cohort 1: Ferric Carboxymaltose (FCM) 7.5 mg/kg Cohort 2: Ferric Carboxymaltose (FCM) 15 mg/kg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/16 (12.50%)      0/19 (0.00%)    
Infections and infestations     
Sinusitis   1/16 (6.25%)  1 0/19 (0.00%)  0
Upper Respiratory Tract Infection   1/16 (6.25%)  1 0/19 (0.00%)  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cohort 1: Ferric Carboxymaltose (FCM) 7.5 mg/kg Cohort 2: Ferric Carboxymaltose (FCM) 15 mg/kg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/16 (56.25%)      12/19 (63.16%)    
Blood and lymphatic system disorders     
Lymphadenitis   0/16 (0.00%)  0 1/19 (5.26%)  1
Eye disorders     
Blepharospasm   0/16 (0.00%)  0 1/19 (5.26%)  1
Gastrointestinal disorders     
Abdominal pain   0/16 (0.00%)  0 1/19 (5.26%)  1
Abdominal pain upper   0/16 (0.00%)  0 1/19 (5.26%)  1
Aphthous stomatitis   0/16 (0.00%)  0 1/19 (5.26%)  1
Constipation   1/16 (6.25%)  1 0/19 (0.00%)  0
Enteritis   0/16 (0.00%)  0 1/19 (5.26%)  1
Gastroduodentitis   0/16 (0.00%)  0 1/19 (5.26%)  1
Gastrooesophageal reflux disease   0/16 (0.00%)  0 1/19 (5.26%)  1
Haematochezia   1/16 (6.25%)  1 0/19 (0.00%)  0
Haemorrhoidal haemorrhage   0/16 (0.00%)  0 1/19 (5.26%)  1
General disorders     
Hyperthermia   0/16 (0.00%)  0 2/19 (10.53%)  2
Infusion site pruritus   1/16 (6.25%)  1 0/19 (0.00%)  0
Injection site pain   0/16 (0.00%)  0 1/19 (5.26%)  1
Pyrexia   2/16 (12.50%)  2 0/19 (0.00%)  0
Thirst   1/16 (6.25%)  1 0/19 (0.00%)  0
Infections and infestations     
Nasopharyngitis   0/16 (0.00%)  0 1/19 (5.26%)  1
Pharyngitis   0/16 (0.00%)  0 1/19 (5.26%)  1
Respiratory tract infection   1/16 (6.25%)  1 0/19 (0.00%)  0
Sinusitis   1/16 (6.25%)  1 0/19 (0.00%)  0
Upper respiratory tract infection   1/16 (6.25%)  1 2/19 (10.53%)  2
Urinary tract infection   1/16 (6.25%)  1 0/19 (0.00%)  0
Viral pharyngitis   0/16 (0.00%)  0 1/19 (5.26%)  1
Investigations     
Alanine aminotransferase increased   0/16 (0.00%)  0 1/19 (5.26%)  1
Aspartate aminotransferase increased   0/16 (0.00%)  0 1/19 (5.26%)  1
Nervous system disorders     
Headache   1/16 (6.25%)  1 1/19 (5.26%)  1
Respiratory, thoracic and mediastinal disorders     
Dysphonia   1/16 (6.25%)  1 0/19 (0.00%)  0
Dyspnoea exertional   0/16 (0.00%)  0 1/19 (5.26%)  1
Epistaxis   0/16 (0.00%)  0 1/19 (5.26%)  1
Rhinorhoea   0/16 (0.00%)  0 3/19 (15.79%)  3
Wheezing   1/16 (6.25%)  1 1/19 (5.26%)  1
Skin and subcutaneous tissue disorders     
Pruritus   0/16 (0.00%)  0 1/19 (5.26%)  1
Rash   2/16 (12.50%)  2 1/19 (5.26%)  1
Rash papular   1/16 (6.25%)  1 0/19 (0.00%)  0
Urticaria   0/16 (0.00%)  0 3/19 (15.79%)  3
Vascular disorders     
Hot flush   1/16 (6.25%)  1 0/19 (0.00%)  0
Hypertension   0/16 (0.00%)  0 1/19 (5.26%)  1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Angelia Butcher
Organization: Luitpold Pharmaceuticals, Inc.
Phone: 610-650-4200 ext 811
EMail: abutcher@lpicrd.com
Layout table for additonal information
Responsible Party: American Regent, Inc.
ClinicalTrials.gov Identifier: NCT02410213     History of Changes
Other Study ID Numbers: 1VIT13036
First Submitted: March 27, 2015
First Posted: April 7, 2015
Results First Submitted: September 22, 2017
Results First Posted: November 29, 2017
Last Update Posted: November 29, 2017