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Completed

NCT Number: NCT00236938

Efficacy and Safety of Venofer (Iron Sucrose Injection USP) in Patients Receiving Peritoneal Dialysis

This is a open-label, prospective study comparing intravenous (IV) iron supplementation to standard care in anemic patents undergoing peritoneal dialysis.

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Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

This is an open-label, prospective study comparing IV iron supplementation to standard care in anemic patients undergoing peritoneal dialysis. After successfully completing a 6 month enrollment period, qualifying patients were randomized to receive 1000mg of IV iron over a four week period, or no iron supplementation. Erythropoietin regimen was to remain stable. Patients were followed to day 71 for safety and efficacy.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Hemoglobin >= 9.5 and <= 11.5 g/dL.
  • Ferritin <= 500 ng/ml.
  • Serum Transferrin Saturation (TSAT) <= 25%.
  • Stable erythropoietin (EPO) Regimen for 8 weeks.
  • No iron for last 4 weeks before randomization.

Exclusion criteria

  • Known Sensitivity to Iron Sucrose.
  • Suffering concomitant severe diseases of the liver & cardiovascular system.
  • Pregnancy / Lactation.
  • Inadequate dialysis.
  • Current treatment for asthma.
  • Significant blood loss.
  • Probability of need for transfusion or transfusion within 1 week of enrollment.
  • Anticipated major surgery.
  • Hemochromatosis / hemosiderosis.

Treatment and study plan

Venofer and stable erythropoietin (EPO) regimen

Drug

Fixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29.

Other names: Iron Sucrose

stable erythropoietin (EPO) regimen

Drug

Stable erythropoietin (EPO) dose and no supplemental iron.

Other names: EPO

Primary outcomes

  1. Mean Change From Baseline to the Highest Hemoglobin up to Day 71

    Time frame: Change from Baseline up to Day 71

Secondary outcomes

  1. The Mean Change From Baseline to the Highest Serum Transferrin Saturation (TSAT) up to Day 71

    Time frame: Change from Baseline up to Day 71

  2. The Mean Change From Baseline to the Highest Ferritin up to Day 71

    Time frame: Change from Baseline up to Day 71

  3. The Mean Change From Baseline to the Highest Reticulocyte Count up to Day 71

    Time frame: Change from Baseline up to Day 71

Sponsors and collaborators

Lead sponsor

American Regent, Inc.

Industry

Registry information

Important dates

Study start
2002
Primary completion
2004
Study completion
2004
First posted
Oct 12, 2005
Registry last updated
May 19, 2021

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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