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

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ClinicalTrials.gov Identifier: NCT00236977
Recruitment Status : Completed
First Posted : October 12, 2005
Results First Posted : March 9, 2010
Last Update Posted : October 6, 2020
Sponsor:
Information provided by:
American Regent, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Anemia Drug: Venofer Drug: Ferrous Sulfate Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 182 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : August 2003
Actual Primary Completion Date : October 2004
Actual Study Completion Date : October 2004

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Patients With an Increase in Hemoglobin >= 1gm/dL. [ Time Frame: Change from Baseline up to Day 56 ]

Secondary Outcome Measures :
  1. Number of Subjects With a Clinical Response [ Time Frame: Change from Baseline up to Day 56 ]
    Clinical Response (change in Hemoblobin (Hgb) >= 1gm/dL and change in ferritin >= 160ng/ml)

  2. Highest Change From Baseline in Hemoglobin (g/dL) up to Day 56 [ Time Frame: Change from Baseline up to Day 56 ]
  3. Highest Change From Baseline in Ferritin (ng/mL) up to Day 56 [ Time Frame: Change from Baseline up to Day 56 ]
  4. Mean Change in Ferritin (ng/mL) From Baseline to Day 56 [ Time Frame: Change from Baseline at Day 56 ]
  5. Mean Change From Baseline in Serum Transferrin Saturation (TSAT) (%) at Day 56 [ Time Frame: Change from Baseline at Day 56 ]
  6. Mean Change From Baseline in Hemoglobin (g/dL) at Day 56 [ Time Frame: Change from Baseline at Day 56 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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): NCT00236977


Locations
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United States, Pennsylvania
Luitpold Pharmaceuticals
Valley Forge, Pennsylvania, United States, 19403
Sponsors and Collaborators
American Regent, Inc.
Investigators
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Study Director: Mark A Falone, MD American Regent, Inc.
Publications of Results:
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Responsible Party: Marc L. Tokars, Luitpold Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00236977    
Other Study ID Numbers: 1VEN03027
First Posted: October 12, 2005    Key Record Dates
Results First Posted: March 9, 2010
Last Update Posted: October 6, 2020
Last Verified: September 2020
Keywords provided by American Regent, Inc.:
CKD
iron
anemia
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Failure, Chronic
Anemia
Hematologic Diseases
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Iron
Ferric Oxide, Saccharated
Trace Elements
Micronutrients
Physiological Effects of Drugs
Hematinics