Back to resultsStudy of the Efficacy of Two Doses of Ferrlecit in the Treatment of Iron Deficiency in Pediatric Hemodialysis Patients
Primary Purpose
Anemia
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Ferrlecit (sodium ferric gluconate complex in sucrose injection)
Sponsored by
About this trial
This is an interventional treatment trial for Anemia focused on measuring Iron Deficiency, Anemia in Pediatric Hemodialysis
Eligibility Criteria
Inclusion Criteria: Male or female pediatric end-stage renal disease (ESRD) patients. Predetermined TSAT and serum ferritin levels Receiving chronic hemodialysis therapy with an identified need for repletion iron therapy. Receiving a stable epoetin (EPO) dosing regimen. Exclusion Criteria: Receipt of any form of iron supplements during the 4 weeks prior to the first Ferrlecit® dosing. Blood transfusion. Hypersensitivity to Ferrlecit®. Significant inflammatory conditions.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
dose level 1
dose level 2
Arm Description
1.5 mg/kg
3 mg/kg
Outcomes
Primary Outcome Measures
Demonstrate and compare effectiveness of two Ferrlecit® doses in increasing hemoglobin in iron-deficient pediatric hemodialysis patients requiring repletion iron therapy.
Secondary Outcome Measures
Evaluate single-dose pharmacokinetics of Ferrlecit® in iron deficient pediatric hemodialysis patients and to access the safety profile of Ferrlecit® in pediatric hemodialysis patients.
Full Information
NCT ID
NCT00223964
First Posted
September 13, 2005
Last Updated
August 10, 2012
Sponsor
Watson Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00223964
Brief Title
Study of the Efficacy of Two Doses of Ferrlecit in the Treatment of Iron Deficiency in Pediatric Hemodialysis Patients
Official Title
Randomized Double-Blind Parallel Group MultiCenter Study of the Efficacy of Two Doses of Ferrlecit® in Treatment of Iron Deficiency in Pediatric Hemodialysis Patients Receiving Epoetin.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
October 2003 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Watson Pharmaceuticals
4. Oversight
5. Study Description
Brief Summary
This was a multi-center study in iron-deficient pediatric hemodialysis patients, whose legal guardian had provided signed informed consent and satisfied the inclusion and exclusion criteria.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia
Keywords
Iron Deficiency, Anemia in Pediatric Hemodialysis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
dose level 1
Arm Type
Experimental
Arm Description
1.5 mg/kg
Arm Title
dose level 2
Arm Type
Experimental
Arm Description
3 mg/kg
Intervention Type
Drug
Intervention Name(s)
Ferrlecit (sodium ferric gluconate complex in sucrose injection)
Primary Outcome Measure Information:
Title
Demonstrate and compare effectiveness of two Ferrlecit® doses in increasing hemoglobin in iron-deficient pediatric hemodialysis patients requiring repletion iron therapy.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Evaluate single-dose pharmacokinetics of Ferrlecit® in iron deficient pediatric hemodialysis patients and to access the safety profile of Ferrlecit® in pediatric hemodialysis patients.
Time Frame
48 hours
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 end-stage renal disease (ESRD) patients.
Predetermined TSAT and serum ferritin levels
Receiving chronic hemodialysis therapy with an identified need for repletion iron therapy.
Receiving a stable epoetin (EPO) dosing regimen.
Exclusion Criteria:
Receipt of any form of iron supplements during the 4 weeks prior to the first Ferrlecit® dosing.
Blood transfusion.
Hypersensitivity to Ferrlecit®.
Significant inflammatory conditions.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GARY HOEL, RPh, PhD
Organizational Affiliation
WATSON LPHARMACEUTICAL
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
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
Seattle
State/Province
Washington
Country
United States
City
Aruascalientes
Country
Mexico
City
Mexico City
Country
Mexico
City
Bialystok
Country
Poland
City
Gdansk
Country
Poland
City
Krakow
Country
Poland
City
Lodz
Country
Poland
City
Lublin
Country
Poland
City
Szczecin
Country
Poland
City
Torum
Country
Poland
City
Wroclaw
Country
Poland
City
Zabrze
Country
Poland
City
Bashkortostan
Country
Russian Federation
City
Moscow
Country
Russian Federation
City
Saint Petersburg
Country
Russian Federation
City
Tartarstan
Country
Russian Federation
City
Belgrade
Country
Serbia
12. IPD Sharing Statement
Learn more about this trial
Study of the Efficacy of Two Doses of Ferrlecit in the Treatment of Iron Deficiency in Pediatric Hemodialysis Patients
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