Back to resultsStudy of the Safety and Efficacy of Ferrlecit® Maintenance Dosing in Pediatric Hemodialysis Patients
Primary Purpose
Anemia
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Sodium Ferric Gluconate Complex in Sucrose.
Sponsored by
About this trial
This is an interventional treatment trial for Anemia focused on measuring Anemia
Eligibility Criteria
Inclusion Criteria: Male or female pediatric ESRD, Patients >_ 2 and <_ 16 years of age, whose legally authorized representative provided signed informed consent. Stabilized on chronic hemodialysis therapy with an identified need for maintenance iron therapy. Predetermined TSAT and serum Ferritin (at the screening visit). Receiving a stable EPO dosing regimen. Exclusion Criteria: Receipt of any form of iron supplementation during the 2 weeks prior to the first Ferrlecit dosing. Hypersensitivity to Ferrlecit or any of its inactive components. High TSAT level. High Serum Ferritin
Sites / Locations
Outcomes
Primary Outcome Measures
Serum Ferritin
Change from baseline to 2 weeks after last Fe dose
Transferrin Saturation
Change from baseline to 2 weeks after last dose
Secondary Outcome Measures
Evaluate the Effect of Intravenous Administration of Ferrlecit on Hematology Parameteres, on EPO Dose, and Safety.
Full Information
NCT ID
NCT00224003
First Posted
September 13, 2005
Last Updated
August 18, 2009
Sponsor
Watson Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00224003
Brief Title
Study of the Safety and Efficacy of Ferrlecit® Maintenance Dosing in Pediatric Hemodialysis Patients
Official Title
Open-Label, Multi-Center Study of the Safety and Efficacy of Ferrlecit® in the Maintenance of Iron Stores in Pediatric Hemodialysis Patients Receiving Epoetin
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
March 2004 (Actual)
Study Completion Date
February 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Watson Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A phase 4 clinical investigation in iron-replete pediatric hemodialysis patients, whose legal guardian had provided signed informed consent, and who had satisfied the inclusion and exclusion criteria of the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia
Keywords
Anemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Sodium Ferric Gluconate Complex in Sucrose.
Primary Outcome Measure Information:
Title
Serum Ferritin
Description
Change from baseline to 2 weeks after last Fe dose
Time Frame
14 weeks
Title
Transferrin Saturation
Description
Change from baseline to 2 weeks after last dose
Time Frame
14 weeks
Secondary Outcome Measure Information:
Title
Evaluate the Effect of Intravenous Administration of Ferrlecit on Hematology Parameteres, on EPO Dose, and Safety.
Time Frame
14 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female pediatric ESRD, Patients >_ 2 and <_ 16 years of age, whose legally authorized representative provided signed informed consent.
Stabilized on chronic hemodialysis therapy with an identified need for maintenance iron therapy.
Predetermined TSAT and serum Ferritin (at the screening visit).
Receiving a stable EPO dosing regimen.
Exclusion Criteria:
Receipt of any form of iron supplementation during the 2 weeks prior to the first Ferrlecit dosing.
Hypersensitivity to Ferrlecit or any of its inactive components.
High TSAT level.
High Serum Ferritin
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary Hoel, RPh, PhD
Organizational Affiliation
Watson Laboratories, Inc.
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
Country
United States
City
Los Angeles
State/Province
California
Country
United States
City
San Diego
State/Province
California
Country
United States
City
Stanford
State/Province
California
Country
United States
City
Atlanta
State/Province
Georgia
Country
United States
City
Boston
State/Province
Massachusetts
Country
United States
City
Kansas City
State/Province
Missouri
Country
United States
City
Bronx
State/Province
New York
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
Seattle
State/Province
Washington
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
16520948
Citation
Warady BA, Zobrist RH, Finan E; Ferrlecit Pediatric Study Group. Sodium ferric gluconate complex maintenance therapy in children on hemodialysis. Pediatr Nephrol. 2006 Apr;21(4):553-60. doi: 10.1007/s00467-006-0042-5. Epub 2006 Mar 7.
Results Reference
result
Learn more about this trial
Study of the Safety and Efficacy of Ferrlecit® Maintenance Dosing in Pediatric Hemodialysis Patients
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