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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:
Information provided by:
Luitpold Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00236964
First received: October 7, 2005
Last updated: October 13, 2005
Last verified: October 2005
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
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:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: October 7, 2005
Last Updated: October 13, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by Luitpold Pharmaceuticals:
Anemia
Chronic Kidney Disease

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

ClinicalTrials.gov processed this record on May 19, 2013