2 Doses of Ferrlecit Versus Oral Iron to Treat Iron-deficiency Anemia in Peritoneal Dialysis Patients.

Overview

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.

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2004

Interventions

  • Drug: Sodium Ferric Gluconate Complex
    • 125 mg weekly x 8 weeks
  • Drug: Sodium Ferric Gluconate Complex
    • 250 mg weekly x 4
  • Drug: Oral Iron
    • 325 mg ferrous sulfate orally three times daily x 8 weeks

Arms, Groups and Cohorts

  • Experimental: Sodium ferric gluconate complex 125 mg
    • 125 mg sodium ferric gluconate weekly x 8 weeks
  • Experimental: Sodium ferric gluconate complex 250 mg
    • 250 mg sodium ferric gluconate complex weekly x 4 weeks
  • Active Comparator: Oral iron
    • 325 mg ferrous sulfate three times daily x 8 weeks

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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
  • 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
  • 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
  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Watson Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Gary Hoel, RPh, PhD, Study Chair, Watson Pharmaceuticals

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