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2 Doses of Ferrlecit Versus Oral Iron to Treat Iron-deficiency Anemia in Peritoneal Dialysis 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: NCT00223977
Recruitment Status : Completed
First Posted : September 22, 2005
Results First Posted : September 28, 2009
Last Update Posted : July 8, 2013
Sponsor:
Information provided by (Responsible Party):
Watson Pharmaceuticals

Brief Summary:
This is a phase 3 clinical investigation. Patients who meet the eligibility criteria and provide signed informed consent will be randomized to receive one of two levels of Ferrlecit or oral iron in a 1:1:1 ratio.

Condition or disease Intervention/treatment Phase
Iron Deficiency Anemia Drug: Sodium Ferric Gluconate Complex Drug: Oral Iron Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 146 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-center, Randomized, Open Label Study of the Efficacy and Safety of Two Doses of Ferrlecit Versus Oral Iron to Treat Iron-deficiency Anemia in Peroneal Dialysis Patients Receiving Erythropoietin.
Study Start Date : December 2003
Actual Primary Completion Date : November 2004
Actual Study Completion Date : February 2008


Arm Intervention/treatment
Experimental: Sodium ferric gluconate complex 125 mg
125 mg sodium ferric gluconate weekly x 8 weeks
Drug: Sodium Ferric Gluconate Complex
125 mg weekly x 8 weeks
Other Name: Ferrlecit

Experimental: Sodium ferric gluconate complex 250 mg
250 mg sodium ferric gluconate complex weekly x 4 weeks
Drug: Sodium Ferric Gluconate Complex
250 mg weekly x 4
Other Name: Ferrlecit

Active Comparator: Oral iron
325 mg ferrous sulfate three times daily x 8 weeks
Drug: Oral Iron
325 mg ferrous sulfate orally three times daily x 8 weeks




Primary Outcome Measures :
  1. Hemoglobin [ Time Frame: Baseline to 5 weeks and 9 weeks ]
    Change from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection


Secondary Outcome Measures :
  1. Change From Baseline in Hematocrit (Hct) [ Time Frame: Baseline to 5 weeks and 9 weeks ]
    Change from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection

  2. Change From Baseline in Transferrin Saturation (TSAT). [ Time Frame: Baseline to 5 weeks and 9 weeks ]
    Change from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection

  3. Change From Baseline in Serum Ferritin. [ Time Frame: Baseline to 5 weeks and 9 weeks ]
    Change from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection

  4. Responders by Treatment Group [ Time Frame: Baseline to 5 weeks and 9 weeks ]
    Patients were classified as responders to treatment if they had an increase in Hgb of at least 1.0 g/dL assessed at 2 weeks following the final administration of Ferrlecit or 1 week following the last dose of oral iron.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female, at least 18 years of age.
  • Received maintenance peritoneal dialysis therapy for at least 4 weeks.
  • Was expected to remain on peritoneal dialysis therapy for duration of study.
  • Had predetermined low hemoglobin and transferrin saturation (TSAT) levels.
  • Signed patient informed consent.

Exclusion Criteria:

  • Had a predetermined serum levels of Ferritin and TSAT
  • Pregnant or lactating.
  • Had a serious concomitant medical disorder incompatible with participation in the study.
  • Had a known hypersensitivity to Ferrlecit or any of its components.
  • Unable to cooperate or comply with the protocol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00223977


Locations
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United States, Alabama
Birmingham, Alabama, United States
United States, Arizona
Mesa, Arizona, United States
United States, California
Los Angeles, California, United States
Torrance, California, United States
United States, Connecticut
New Haven, Connecticut, United States
United States, Illinois
Evanston, Illinois, United States
United States, Louisiana
Shreveport, Louisiana, United States
United States, Massachusetts
Springfield, Massachusetts, United States
Worcester, Massachusetts, United States
United States, Michigan
Royal Oak, Michigan, United States
United States, Missouri
St. Louis, Missouri, United States
United States, New York
New York, New York, United States
United States, North Carolina
Chapel Hill, North Carolina, United States
Winston-salem, North Carolina, United States
United States, Oklahoma
Tulsa, Oklahoma, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
United States, South Dakota
Sioux Falls, South Dakota, United States
United States, Texas
Dallas, Texas, United States
United States, Virginia
Richmond, Virginia, United States
Bulgaria
Sofia, Bulgaria
Varna, Bulgaria
Canada
Kelowna, Canada
Kitchener, Canada
London, Canada
Scarborough, Canada
Toronto, Canada
Croatia
Zagreb, Croatia
India
Bangalore, India
Chandigarh, India
Chennai, India
Hyderabad, India
Lucknow, India
Mahim, India
New Delhi, India
Mexico
Col. Toriello Guerra, Mexico
Durango, Mexico
Mexico City, Mexico
Monterrey, Mexico
Tlalpan, Mexico
Zapopan, Mexico
Poland
Osijek, Poland
Russian Federation
Moscow, Russian Federation
St. Petersburg, Russian Federation
Sponsors and Collaborators
Watson Pharmaceuticals
Investigators
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Study Chair: Gary Hoel, RPh, PhD Watson Pharmaceuticals

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Responsible Party: Watson Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00223977    
Other Study ID Numbers: FR03001
First Posted: September 22, 2005    Key Record Dates
Results First Posted: September 28, 2009
Last Update Posted: July 8, 2013
Last Verified: May 2013
Keywords provided by Watson Pharmaceuticals:
Anemia.
Additional relevant MeSH terms:
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Anemia
Anemia, Iron-Deficiency
Deficiency Diseases
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Malnutrition
Nutrition Disorders
Iron
Ferric gluconate
Ferric Compounds
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Hematinics