Back to resultsEffect of Ferrlecit® Versus Oral Iron on Iron Deficient Chronic Kidney Disease (CKD) Patients
Primary Purpose
Anemia, Iron-Deficiency, Kidney Failure, Chronic
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Sodium Ferric Gluconate Complex in Sucrose Injection
Ferrous sulfate tablets
Sponsored by
About this trial
This is an interventional treatment trial for Anemia, Iron-Deficiency focused on measuring Iron deficiency, Anemia, Chronic kidney disease, Sodium Ferric Gluconate, Anemia, Iron-Deficiency/drug therapy/etiology, Kidney Failure, Chronic/blood/complications/therapy
Eligibility Criteria
Inclusion Criteria: Moderate to severe anemia Iron deficiency Moderate to severe chronic kidney disease Exclusion Criteria: Receiving dialysis Known sensitivity to Ferrlecit® or any of its components Receiving therapy with erythropoietic agent Clinically unstable
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
IV iron
oral iron
Arm Description
Sodium ferric gluconate
ferrous sulfate
Outcomes
Primary Outcome Measures
Change in Hemoglobin (Hgb)
Change from baseline to 7 weeks after 4 consecutive weekly Ferrlecit 250 mg intravenious infusion and change from baseline to 4 weeks after 6 weeks oral ferrous sulfate 325 mg tablets t.i.d.
Secondary Outcome Measures
Change in Serum Ferritin
Change from baseline to 7 weeks after 4 consecutive weekly Ferrlecit 250 mg intravenious infusion and change from baseline to 4 weeks after 6 weeks oral ferrous sulfate 325 mg tablets t.i.d.
Full Information
NCT ID
NCT00224055
First Posted
September 13, 2005
Last Updated
February 29, 2012
Sponsor
Watson Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00224055
Brief Title
Effect of Ferrlecit® Versus Oral Iron on Iron Deficient Chronic Kidney Disease (CKD) Patients
Official Title
A Randomized, Controlled, Open-label Study of the Safety and Efficacy of Ferrlecit® vs Oral Iron in Iron Deficient Patients With Chronic Kidney Disease
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
September 2004 (Actual)
Study Completion Date
September 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Watson Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study compares the effect of Ferrlecit® (a form of intravenous iron) to ferrous sulfate (a form of oral iron) in treating anemia and iron deficiency in chronic kidney disease patients who are not receiving erythropoietic agents (hormones that stimulate the bone marrow to make more red blood cells).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Iron-Deficiency, Kidney Failure, Chronic
Keywords
Iron deficiency, Anemia, Chronic kidney disease, Sodium Ferric Gluconate, Anemia, Iron-Deficiency/drug therapy/etiology, Kidney Failure, Chronic/blood/complications/therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
89 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IV iron
Arm Type
Experimental
Arm Description
Sodium ferric gluconate
Arm Title
oral iron
Arm Type
Active Comparator
Arm Description
ferrous sulfate
Intervention Type
Drug
Intervention Name(s)
Sodium Ferric Gluconate Complex in Sucrose Injection
Intervention Description
Sodium Ferric Gluconate Complex in Sucrose Injection (Ferrlecit®), 250 mg IV weekly for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Ferrous sulfate tablets
Intervention Description
ferrous sulfate, 325 mg oral, three times daily for 6 weeks
Primary Outcome Measure Information:
Title
Change in Hemoglobin (Hgb)
Description
Change from baseline to 7 weeks after 4 consecutive weekly Ferrlecit 250 mg intravenious infusion and change from baseline to 4 weeks after 6 weeks oral ferrous sulfate 325 mg tablets t.i.d.
Time Frame
Baseline to 10 weeks
Secondary Outcome Measure Information:
Title
Change in Serum Ferritin
Description
Change from baseline to 7 weeks after 4 consecutive weekly Ferrlecit 250 mg intravenious infusion and change from baseline to 4 weeks after 6 weeks oral ferrous sulfate 325 mg tablets t.i.d.
Time Frame
Baseline to 10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Moderate to severe anemia
Iron deficiency
Moderate to severe chronic kidney disease
Exclusion Criteria:
Receiving dialysis
Known sensitivity to Ferrlecit® or any of its components
Receiving therapy with erythropoietic agent
Clinically unstable
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naomi Dahl, Pharm.D.
Organizational Affiliation
Watson Laboratories, Inc.
Official's Role
Study Director
Facility Information:
City
Tucson
State/Province
Arizona
Country
United States
City
Los Angeles
State/Province
California
Country
United States
City
Palo Alto
State/Province
California
Country
United States
City
San Diego
State/Province
California
Country
United States
City
Hines
State/Province
Illinois
Country
United States
City
Indianapolis
State/Province
Indiana
Country
United States
City
Shreveport
State/Province
Louisiana
Country
United States
City
Baltimore
State/Province
Maryland
Country
United States
City
Springfield
State/Province
Massachusetts
Country
United States
City
Detroit
State/Province
Michigan
Country
United States
City
St. Louis
State/Province
Missouri
Country
United States
City
Birmingham
State/Province
New York
Country
United States
City
Bronx
State/Province
New York
Country
United States
City
Mineola
State/Province
New York
Country
United States
City
New York
State/Province
New York
Country
United States
City
Chapel Hill
State/Province
North Carolina
Country
United States
City
Cleveland
State/Province
Ohio
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
Charlotte
State/Province
South Carolina
Country
United States
City
Chattanooga
State/Province
Tennessee
Country
United States
City
Memphis
State/Province
Tennessee
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
Fairfax
State/Province
Virginia
Country
United States
City
San Juan
Country
Puerto Rico
12. IPD Sharing Statement
Citations:
PubMed Identifier
17035697
Citation
Agarwal R, Rizkala AR, Bastani B, Kaskas MO, Leehey DJ, Besarab A. A randomized controlled trial of oral versus intravenous iron in chronic kidney disease. Am J Nephrol. 2006;26(5):445-54. doi: 10.1159/000096174. Epub 2006 Oct 11.
Results Reference
result
Learn more about this trial
Effect of Ferrlecit® Versus Oral Iron on Iron Deficient Chronic Kidney Disease (CKD) Patients
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