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

This study has been completed.
Information provided by:
Luitpold Pharmaceuticals Identifier:
First received: October 7, 2005
Last updated: October 13, 2005
Last verified: October 2005
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.

Condition Intervention Phase
Anemia Drug: Iron Sucrose + Erythropoietin Drug: Ferrous Sulfate + Erythropoietin Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Educational/Counseling/Training
Official Title: Comparison of Oral Iron With IV Iron in Patients With Anemia of Chronic Renal Failure Not on Dialysis

Resource links provided by NLM:

Further study details as provided by Luitpold Pharmaceuticals:

Primary Outcome Measures:
  • Mean Change in Hemoglobin and Serum Ferritin at day 43

Secondary Outcome Measures:
  • Clinical success (change in Hgb > 12 & Change in Ferritin 180)
  • Maximum change in Hemoglobin during the study

Estimated Enrollment: 78
Study Start Date: February 2001
Estimated Study Completion Date: May 2002
Detailed Description:
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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Creatine Clearance <40 mL/min
  • Average Baseline Hemoglobin < 10.5g/dL
  • 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00236964

Sponsors and Collaborators
Luitpold Pharmaceuticals
Study Director: Antoinette Mangione, MD, PharmD Medical Director
  More Information

Publications: Identifier: NCT00236964     History of Changes
Other Study ID Numbers: 1VEN99012
Study First Received: October 7, 2005
Last Updated: October 13, 2005

Keywords provided by Luitpold Pharmaceuticals:
Chronic Kidney Disease

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Failure, Chronic
Hematologic Diseases
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Ferric oxide, saccharated
Epoetin Alfa
Trace Elements
Growth Substances
Physiological Effects of Drugs
Hematinics processed this record on August 16, 2017