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Completed

NCT Number: NCT00236977

Comparison of Safety and Efficacy of Intravenous Iron Versus Oral Iron in Chronic Renal Failure Subjects With Anemia

To assess the safety and efficacy of two forms of iron therapy for the treatment of anemia in non-dialysis dependent, chronic renal failure in patients receiving or not receiving erythropoietin.

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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

Primary location

Luitpold Pharmaceuticals

Valley Forge, Pennsylvania, 19403, United States

About this study

The intent of this study was to assess the safety and efficacy of two forms of iron therapy for the treatment of anemia in non-dialysis dependent, chronic renal failure patients receiving or not receiving erythropoietin. After an extensive enrollment period, patients were randomized to receive oral iron (ferrous sulfate, 325mg three times daily (TID) for 56 days) or IV iron sucrose (total 1000mg, 500mg X 2 OR 200mg X 5 within two weeks). Erythropoietin schedule was to remain unchanged during the 56 day study.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Hemoglobin < or = 11.5 gm/dL
  • Stable dose or not receiving EPO
  • Renal Anemia

Exclusion criteria

  • IV iron with last 6 months
  • Chronic infection, malignancy,major surgery within last month
  • Blood Transfusion with last two months
  • Significant blood loss within last 3 months
  • Concomitant sever diseases of the liver

Treatment and study plan

Venofer

Drug

iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14.

Other names: iron sucrose tablets

Ferrous Sulfate

Drug

oral iron tablets; 325 mg three times a day orally for 56 days

Other names: Oral Iron Tablets

Primary outcomes

  1. Patients With an Increase in Hemoglobin >= 1gm/dL.

    Time frame: Change from Baseline up to Day 56

Secondary outcomes

  1. Number of Subjects With a Clinical Response

    Time frame: Change from Baseline up to Day 56

    Clinical Response (change in Hemoblobin (Hgb) >= 1gm/dL and change in ferritin >= 160ng/ml)

  2. Highest Change From Baseline in Hemoglobin (g/dL) up to Day 56

    Time frame: Change from Baseline up to Day 56

  3. Highest Change From Baseline in Ferritin (ng/mL) up to Day 56

    Time frame: Change from Baseline up to Day 56

  4. Mean Change in Ferritin (ng/mL) From Baseline to Day 56

    Time frame: Change from Baseline at Day 56

  5. Mean Change From Baseline in Serum Transferrin Saturation (TSAT) (%) at Day 56

    Time frame: Change from Baseline at Day 56

  6. Mean Change From Baseline in Hemoglobin (g/dL) at Day 56

    Time frame: Change from Baseline at Day 56

Sponsors and collaborators

Lead sponsor

American Regent, Inc.

Industry

Registry information

Official study title

Comparison of the Safety and Efficacy of Intravenous Iron Versus Oral Iron in Chronic Renal Failure Subjects With Anemia

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Oct 12, 2005
Registry last updated
Oct 6, 2020

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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