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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00236964
First Posted: October 12, 2005
Last Update Posted: October 17, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Luitpold Pharmaceuticals
  Purpose
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: None (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.
  Eligibility

Information from the National Library of Medicine

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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00236964


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

Publications:
ClinicalTrials.gov Identifier: NCT00236964     History of Changes
Other Study ID Numbers: 1VEN99012
First Submitted: October 7, 2005
First Posted: October 12, 2005
Last Update Posted: October 17, 2005
Last Verified: October 2005

Keywords provided by Luitpold Pharmaceuticals:
Anemia
Chronic Kidney Disease

Additional relevant MeSH terms:
Anemia
Renal Insufficiency
Kidney Failure, Chronic
Hematologic Diseases
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Iron
Ferric oxide, saccharated
Epoetin Alfa
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hematinics