Comparison of Oral Iron With IV Iron in Patients With Anemia of Chronic Renal Failure Not on Dialysis - Full Text View

Sponsored by:	Luitpold Pharmaceuticals
Information provided by:	Luitpold Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00236964

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 III

MedlinePlus related topics: Anemia Kidney Failure

Drug Information available for: Epoetin alfa Erythropoietin Ferrous sulfate Sucrose Ferric oxide, saccharated

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Educational/Counseling/Training, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Comparison of Oral Iron With IV Iron in Patients With Anemia of Chronic Renal Failure Not on Dialysis

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 of Results:

Charytan C, Qunibi W, Bailie GR; Venofer Clinical Studies Group. Comparison of intravenous iron sucrose to oral iron in the treatment of anemic patients with chronic kidney disease not on dialysis. Nephron Clin Pract. 2005;100(3):c55-62. Epub 2005 Apr 11.

Study ID Numbers:	1VEN99012
Study First Received:	October 7, 2005
Last Updated:	October 13, 2005
ClinicalTrials.gov Identifier:	NCT00236964
Health Authority:	United States: Food and Drug Administration

Keywords provided by Luitpold Pharmaceuticals:

Anemia
Chronic Kidney Disease

Study placed in the following topic categories:

Epoetin Alfa
Ferric oxide, saccharated
Renal Insufficiency
Urologic Diseases
Hematologic Diseases
Renal Insufficiency, Chronic

Anemia
Kidney Failure, Chronic
Kidney Diseases
Iron
Kidney Failure

Additional relevant MeSH terms:

Hematinics
Growth Substances
Therapeutic Uses
Physiological Effects of Drugs

Hematologic Agents
Trace Elements
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009