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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

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 22, 2005
Results First Submitted Date  ICMJE August 18, 2009
Results First Posted Date  ICMJE September 28, 2009
Last Update Posted Date September 28, 2009
Study Start Date  ICMJE April 2003
Actual Primary Completion Date March 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 18, 2009)
  • Serum Ferritin [ Time Frame: 14 weeks ]
    Change from baseline to 2 weeks after last Fe dose
  • Transferrin Saturation [ Time Frame: 14 weeks ]
    Change from baseline to 2 weeks after last dose
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
Primary objective was to evaluate the effects of intravenous administration of Ferrlecit on the maintenance of the iron indices, within ranges that were indicative of an iron-replete state in pediatric hemodialysis patients receiving erythopoietin.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2009)
Evaluate the Effect of Intravenous Administration of Ferrlecit on Hematology Parameteres, on EPO Dose, and Safety. [ Time Frame: 14 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
Evaluate the Effect of Intravenous Administration of Ferrlecit on Hematology Parameteres, on EPO Dose, and Safety.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of the Safety and Efficacy of Ferrlecit® Maintenance Dosing in Pediatric Hemodialysis Patients
Official Title  ICMJE Open-Label, Multi-Center Study of the Safety and Efficacy of Ferrlecit® in the Maintenance of Iron Stores in Pediatric Hemodialysis Patients Receiving Epoetin
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Anemia
Intervention  ICMJE Drug: Sodium Ferric Gluconate Complex in Sucrose.
Study Arms  ICMJE Not Provided
Publications * 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. Epub 2006 Mar 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 18, 2009)
23
Original Enrollment  ICMJE
 (submitted: September 13, 2005)
60
Actual Study Completion Date  ICMJE February 2005
Actual Primary Completion Date March 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00224003
Other Study ID Numbers  ICMJE FRO2001
FDA
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gary Hoel, RPh, PhD Executive Director, Clinical Research, Watson Laboratory, Inc
Study Sponsor  ICMJE Watson Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Gary Hoel, RPh, PhD Watson Laboratories, Inc.
PRS Account Watson Pharmaceuticals
Verification Date August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP