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Study of the Safety and Efficacy of Ferrlecit® Maintenance Dosing in Pediatric Hemodialysis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00224003
Recruitment Status : Completed
First Posted : September 22, 2005
Results First Posted : September 28, 2009
Last Update Posted : September 28, 2009
Sponsor:
Information provided by:
Watson Pharmaceuticals

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Anemia
Intervention Drug: Sodium Ferric Gluconate Complex in Sucrose.
Enrollment 23
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sodium Ferric Gluconate Complex
Hide Arm/Group Description [Not Specified]
Period Title: Overall Study
Started 23 [1]
Completed 16 [2]
Not Completed 7
Reason Not Completed
Adverse Event             1
Protocol Violation             2
Withdrawal by Subject             1
unk             3
[1]
First patient in: April 2, 2003
[2]
Last patient out: March 31, 2004
Arm/Group Title Sodium Ferric Gluconate Complex
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 23
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants
<=18 years
23
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 23 participants
13.2  (2.39)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants
Female
7
  30.4%
Male
16
  69.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 23 participants
23
1.Primary Outcome
Title Serum Ferritin
Hide Description Change from baseline to 2 weeks after last Fe dose
Time Frame 14 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol (completer) population
Arm/Group Title Sodium Ferric Gluconate Complex
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: ng/mL
26.7  (240.05)
2.Primary Outcome
Title Transferrin Saturation
Hide Description Change from baseline to 2 weeks after last dose
Time Frame 14 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol (completer) population
Arm/Group Title Sodium Ferric Gluconate Complex
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: %
2.0  (11.67)
3.Secondary Outcome
Title Evaluate the Effect of Intravenous Administration of Ferrlecit on Hematology Parameteres, on EPO Dose, and Safety.
Hide Description [Not Specified]
Time Frame 14 weeks
Outcome Measure Data Not Reported
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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: Gary Hoel, RPh, PhD
Organization: Watson Laboratories, Inc
Phone: 801-588-6641
EMail: gary.hoel@watson.com
Layout table for additonal information
Responsible Party: Gary Hoel, RPh, PhD Executive Director, Clinical Research, Watson Laboratory, Inc
ClinicalTrials.gov Identifier: NCT00224003    
Other Study ID Numbers: FRO2001
FDA
First Submitted: September 13, 2005
First Posted: September 22, 2005
Results First Submitted: August 18, 2009
Results First Posted: September 28, 2009
Last Update Posted: September 28, 2009