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OpenTrials
Completed

NCT Number: NCT00236964

Comparison of Oral Iron With IV Iron in Patients With Anemia of Chronic Renal Failure Not on Dialysis

The purpose of the study was to compare the efficacy of oral iron (ferrous sulfate) plus erythropoietin to Iron Sucrose plus erythropoietin for managing anemia patients with chronic renal failure who are not receiving dialysis.

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Key information

Conditions

Anemia Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hematologic Diseases Hemic and Lymphatic Diseases Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

Randomized open-label multicenter active-controlled study of anemic patients with Chronic Renal Failure who are not yet receiving dialysis. The duration of the study was five months. After screening procedures including multiple hemoglobin values, patients were randomly assigned to either IV Iron Sucrose (200mg X 5) or oral iron sulfate (325mg TID)for 29 days. Safety assessments included the recording of all adverse events, physical examinations, vital signs, electrocardiograms and clinical laboratory tests. Efficacy parameters included hematologic parameters.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Creatine Clearance <40 mL/min
  • Average Baseline Hemoglobin < 10.5g/dL
  • Serum Transferrin Saturation (TSAT) < 25% and Ferritin <300ng/mL

Exclusion criteria

  • Blood Transfusion within 30days
  • Uncontrolled Hypertension
  • Suffering form concommitant disease of the liver
  • Serious bacterial infection
  • Pregnancy / lactation
  • Symptomatic HIV
  • Expected to under dialysis or renal transplant during study

Treatment and study plan

Iron Sucrose + Erythropoietin

Drug

The total dose of iron sucrose was 1,000 mg. Participants also received erythropoietin 2,000 units subcutaneously on Days 1, 8, 15, 22, 29, and 36.

Other names: Venofer

Oral Iron + Erythropoietin

Drug

Oral iron 325 mg three time daily for 29 days. Participants also received erythropoietin 2,000 units subcutaneously on Days 1, 8, 15, 22, 29, and 36.

Other names: Ferrous sulfate

Primary outcomes

  1. Mean Change in Hemoglobin

    Time frame: Baseline and Day 43

    Change in hemoglobin g/dL from baseline to Day 43 was analyzed using parametric analysis of covariance (ANCOVA).

  2. Mean Change in Serum Ferritin

    Time frame: Baseline and Day 43

    Change in Ferritin ng/mL from baseline to Day 43 was analyzed using parametric analysis of covariance (ANCOVA).

Secondary outcomes

  1. Clinical Success (Change in Hemoglobin)

    Time frame: Baseline and Day 43

    Participants were considered to have achieved clinical success if they attained a change in hemoglobin ≥0.8 g/dL. The difference from baseline to Day 43 was calculated and rounded.

  2. Clinical success (change in Ferritin)

    Time frame: Baseline and Day 43

    Participants were considered to have achieved clinical success if they attained a change in ferritin ≥160 ng/mL. The difference from baseline to Day 43 was calculated and rounded.

Sponsors and collaborators

Lead sponsor

American Regent, Inc.

Industry

Registry information

Important dates

Study start
2001
Primary completion
2002
Study completion
2002
First posted
Oct 12, 2005
Registry last updated
May 9, 2025

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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