Comparison of Safety and Efficacy of Intravenous Iron Versus Oral Iron in Chronic Renal Failure Subjects With Anemia

This study has been completed.
Sponsor:
Information provided by:
Luitpold Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00236977
First received: October 7, 2005
Last updated: March 11, 2010
Last verified: February 2010
  Purpose

To assess the safety and efficacy of two forms of iron therapy for the treatment of anemia in non-dialysis dependent, chronic renal failure in patients receiving or not receiving erythropoietin.


Condition Intervention Phase
Anemia
Drug: Venofer
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 the Safety and Efficacy of Intravenous Iron Versus Oral Iron in Chronic Renal Failure Subjects With Anemia

Resource links provided by NLM:


Further study details as provided by Luitpold Pharmaceuticals:

Primary Outcome Measures:
  • Patients With an Increase in Hemoglobin >= 1gm/dL. [ Time Frame: Change from Baseline up to Day 56 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Subjects With a Clinical Response [ Time Frame: Change from Baseline up to Day 56 ] [ Designated as safety issue: No ]
    Clinical Response (change in Hemoblobin (Hgb) >= 1gm/dL and change in ferritin >= 160ng/ml)

  • Highest Change From Baseline in Hemoglobin (g/dL) up to Day 56 [ Time Frame: Change from Baseline up to Day 56 ] [ Designated as safety issue: No ]
  • Highest Change From Baseline in Ferritin (ng/mL) up to Day 56 [ Time Frame: Change from Baseline up to Day 56 ] [ Designated as safety issue: No ]
  • Mean Change in Ferritin (ng/mL) From Baseline to Day 56 [ Time Frame: Change from Baseline at Day 56 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline in Serum Transferrin Saturation (TSAT) (%) at Day 56 [ Time Frame: Change from Baseline at Day 56 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline in Hemoglobin (g/dL) at Day 56 [ Time Frame: Change from Baseline at Day 56 ] [ Designated as safety issue: No ]

Enrollment: 182
Study Start Date: August 2003
Study Completion Date: October 2004
Primary Completion Date: October 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Venofer
iron sucrose injection
Drug: Venofer
iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14.
Other Name: iron sucrose tablets
Active Comparator: Ferrous Sulfate
oral iron
Drug: Ferrous Sulfate
oral iron tablets; 325 mg three times a day orally for 56 days
Other Name: Oral Iron Tablets

Detailed Description:

The intent of this study was to assess the safety and efficacy of two forms of iron therapy for the treatment of anemia in non-dialysis dependent, chronic renal failure patients receiving or not receiving erythropoietin. After an extensive enrollment period, patients were randomized to receive oral iron (ferrous sulfate, 325mg three times daily (TID) for 56 days) or IV iron sucrose (total 1000mg, 500mg X 2 OR 200mg X 5 within two weeks). Erythropoietin schedule was to remain unchanged during the 56 day study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hemoglobin < or = 11.5 gm/dL
  • Stable dose or not receiving EPO
  • Renal Anemia

Exclusion Criteria:

  • IV iron with last 6 months
  • Chronic infection, malignancy,major surgery within last month
  • Blood Transfusion with last two months
  • Significant blood loss within last 3 months
  • Concomitant sever diseases of the liver
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00236977

Locations
United States, Pennsylvania
Luitpold Pharmaceuticals
Valley Forge, Pennsylvania, United States, 19403
Sponsors and Collaborators
Luitpold Pharmaceuticals
Investigators
Study Director: Marc L. Tokars Luitpold Pharmaceuticals
  More Information

No publications provided

Responsible Party: Marc L. Tokars, Luitpold Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00236977     History of Changes
Other Study ID Numbers: 1VEN03027
Study First Received: October 7, 2005
Results First Received: January 14, 2009
Last Updated: March 11, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Luitpold Pharmaceuticals:
CKD
iron
anemia

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

ClinicalTrials.gov processed this record on October 20, 2014