Study of the Efficacy of Two Doses of Ferrlecit in the Treatment of Iron Deficiency in Pediatric Hemodialysis Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Watson Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00223964
First received: September 13, 2005
Last updated: August 10, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Anemia
Drug: Ferrlecit (sodium ferric gluconate complex in sucrose injection)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Watson Pharmaceuticals:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

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. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Enrollment: 59
Study Start Date: June 2003
Primary Completion Date: October 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: dose level 1
1.5 mg/kg
Drug: Ferrlecit (sodium ferric gluconate complex in sucrose injection)
Experimental: dose level 2
3 mg/kg
Drug: Ferrlecit (sodium ferric gluconate complex in sucrose injection)

  Eligibility

Ages Eligible for Study:   2 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00223964

Locations
United States, Alabama
Birmingham, Alabama, United States
United States, California
Los Angeles, California, United States
San Diego, California, United States
Stanford, California, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, Missouri
Kansas City, Missouri, United States
United States, New York
Bronx, New York, United States
United States, Washington
Seattle, Washington, United States
Mexico
Aruascalientes, Mexico
Mexico City, Mexico
Poland
Bialystok, Poland
Gdansk, Poland
Krakow, Poland
Lodz, Poland
Lublin, Poland
Szczecin, Poland
Torum, Poland
Wroclaw, Poland
Zabrze, Poland
Russian Federation
Bashkortostan, Russian Federation
Moscow, Russian Federation
Saint Petersburg, Russian Federation
Tartarstan, Russian Federation
Serbia
Belgrade, Serbia
Sponsors and Collaborators
Watson Pharmaceuticals
Investigators
Study Director: GARY HOEL, RPh, PhD WATSON LPHARMACEUTICAL
  More Information

No publications provided

Responsible Party: Watson Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00223964     History of Changes
Other Study ID Numbers: FR01006
Study First Received: September 13, 2005
Last Updated: August 10, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Watson Pharmaceuticals:
Iron Deficiency
Anemia in Pediatric Hemodialysis

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Ferric gluconate
Ferric Compounds
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014