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VIT45 Versus Oral Iron in the Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease

This study has been completed.
Sponsor:
Information provided by:
Luitpold Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00317239
First received: April 20, 2006
Last updated: October 7, 2010
Last verified: October 2010
History of Changes
  Purpose

This study compares the efficacy and safety of intravenous (IV) iron (VIT45) versus oral iron (ferrous sulfate) administered to subjects who suffer from anemia and are diagnosed with non-dialysis dependent chronic kidney disease (NDD-CKD).


Condition Intervention Phase
Anemia
 Drug: Ferrous Sulfate
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Safety & Efficacy of Intravenous Iron (VIT45) vs Oral Iron in the Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Luitpold Pharmaceuticals:

Primary Outcome Measures:
  • Number of patients achieving an increase in hemoglobin > or = 1gm

Secondary Outcome Measures:
  • Mean change in hemoglobin from baseline

Enrollment: 255
Study Start Date: May 2005
Study Completion Date: January 2007
Detailed Description:

This study compares the efficacy and safety of intravenous (IV) iron (VIT45) versus oral iron (ferrous sulfate) administered to subjects who suffer from anemia and are diagnosed with non-dialysis dependent chronic kidney disease (NDD-CKD).

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males or females > or = 12 years of age
  • NDD-CKD subjects
  • Baseline hemoglobin < or = 11g/dl
  • Stable erythropoietin (EPO) status

Exclusion Criteria:

  • Known hypersensitivity to ferrous sulfate or IV iron
  • Unstable EPO status
  • Anemia not related to CKD
  • Chronic, serious infection
  • Recent IV iron
  • Recent blood transfusion
  • Recent blood loss
  • Need for surgery
  • Received investigational drug within 30 days
  • Female subjects who are pregnant or lactating
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00317239

Locations
United States, Pennsylvania
Luitpold Pharmaceuticals
Norristown, Pennsylvania, United States, 19518
Sponsors and Collaborators
Luitpold Pharmaceuticals
Investigators
Study Director: David Bregman, M.D., Ph.D. Luitpold Pharmaceuticals
  More Information

Publications:
Qunibi W, Martinez C, Smith M, Benjamin J, Mangione A. A Randomized Controlled Trial Comparing Intravenous Ferric Carboxymaltose to Oral Iron in Anemic Patients with Non-Dialysis-Dependent CKD. American Society of Nephrology Renal Week 2007.

ClinicalTrials.gov Identifier: NCT00317239     History of Changes
Other Study ID Numbers: 1VIT04004
Study First Received: April 20, 2006
Last Updated: October 7, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Luitpold Pharmaceuticals:
Anemia
Chronic Kidney Disease
Iron

Additional relevant MeSH terms:
Anemia
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
 Hematologic Diseases
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on May 22, 2013