Back to resultsComparison of Safety and Efficacy of Intravenous Iron Versus Oral Iron in Chronic Renal Failure Subjects With Anemia
Primary Purpose
Anemia
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Venofer
Ferrous Sulfate
Sponsored by
About this trial
This is an interventional treatment trial for Anemia focused on measuring CKD, iron, anemia
Eligibility 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
Sites / Locations
- Luitpold Pharmaceuticals
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Venofer
Ferrous Sulfate
Arm Description
iron sucrose injection
oral iron
Outcomes
Primary Outcome Measures
Patients With an Increase in Hemoglobin >= 1gm/dL.
Secondary Outcome Measures
Number of Subjects With a Clinical Response
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
Highest Change From Baseline in Ferritin (ng/mL) up to Day 56
Mean Change in Ferritin (ng/mL) From Baseline to Day 56
Mean Change From Baseline in Serum Transferrin Saturation (TSAT) (%) at Day 56
Mean Change From Baseline in Hemoglobin (g/dL) at Day 56
Full Information
NCT ID
NCT00236977
First Posted
October 7, 2005
Last Updated
September 16, 2020
Sponsor
American Regent, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00236977
Brief Title
Comparison of Safety and Efficacy of Intravenous Iron Versus Oral Iron in Chronic Renal Failure Subjects With Anemia
Official Title
Comparison of the Safety and Efficacy of Intravenous Iron Versus Oral Iron in Chronic Renal Failure Subjects With Anemia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
October 2004 (Actual)
Study Completion Date
October 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
American Regent, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia
Keywords
CKD, iron, anemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
182 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Venofer
Arm Type
Experimental
Arm Description
iron sucrose injection
Arm Title
Ferrous Sulfate
Arm Type
Active Comparator
Arm Description
oral iron
Intervention Type
Drug
Intervention Name(s)
Venofer
Other Intervention Name(s)
iron sucrose tablets
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Ferrous Sulfate
Other Intervention Name(s)
Oral Iron Tablets
Intervention Description
oral iron tablets; 325 mg three times a day orally for 56 days
Primary Outcome Measure Information:
Title
Patients With an Increase in Hemoglobin >= 1gm/dL.
Time Frame
Change from Baseline up to Day 56
Secondary Outcome Measure Information:
Title
Number of Subjects With a Clinical Response
Description
Clinical Response (change in Hemoblobin (Hgb) >= 1gm/dL and change in ferritin >= 160ng/ml)
Time Frame
Change from Baseline up to Day 56
Title
Highest Change From Baseline in Hemoglobin (g/dL) up to Day 56
Time Frame
Change from Baseline up to Day 56
Title
Highest Change From Baseline in Ferritin (ng/mL) up to Day 56
Time Frame
Change from Baseline up to Day 56
Title
Mean Change in Ferritin (ng/mL) From Baseline to Day 56
Time Frame
Change from Baseline at Day 56
Title
Mean Change From Baseline in Serum Transferrin Saturation (TSAT) (%) at Day 56
Time Frame
Change from Baseline at Day 56
Title
Mean Change From Baseline in Hemoglobin (g/dL) at Day 56
Time Frame
Change from Baseline at Day 56
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark A Falone, MD
Organizational Affiliation
American Regent, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Luitpold Pharmaceuticals
City
Valley Forge
State/Province
Pennsylvania
ZIP/Postal Code
19403
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
16316362
Citation
Van Wyck DB, Roppolo M, Martinez CO, Mazey RM, McMurray S; United States Iron Sucrose (Venofer) Clinical Trials Group. A randomized, controlled trial comparing IV iron sucrose to oral iron in anemic patients with nondialysis-dependent CKD. Kidney Int. 2005 Dec;68(6):2846-56. doi: 10.1111/j.1523-1755.2005.00758.x.
Results Reference
result
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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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