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OpenTrials
Completed

NCT Number: NCT00223977

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

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.

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Key information

Conditions

Iron Deficiency Anemia Anemia Anemia, Hypochromic Anemia, Iron-Deficiency Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Sofia, Bulgaria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sodium Ferric Gluconate Complex

Drug

125 mg weekly x 8 weeks

Other names: Ferrlecit

oral iron

Drug

325 mg ferrous sulfate orally three times daily x 8 weeks

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Watson Pharmaceuticals

Industry

Registry information

Official study 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.

Important dates

Study start
2003
Primary completion
2004
Study completion
2008
First posted
Sep 22, 2005
Registry last updated
Jul 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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