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Effect of Ferrlecit® Versus Oral Iron on Iron Deficient Chronic Kidney Disease (CKD) Patients Receiving Erythropoietic Agents

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
Ferrous sulfate tablets
Sponsored by
Watson Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia, Iron-Deficiency focused on measuring Iron deficiency, Anemia, Chronic kidney disease, Erythropoietic agents, Sodium Ferric Gluconate, Anemia, Iron-Deficiency/drug therapy/etiology, Kidney Failure, Chronic/blood/complications/therapy, Erythropoietin, Recombinant/adverse effects/therapeutic use

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Moderate to severe anemia Iron deficiency Moderate to severe chronic kidney disease Receiving therapy with erythropoietic agent Exclusion Criteria: Receiving dialysis Known sensitivity to Ferrlecit® or any of its components 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

Outcomes

Primary Outcome Measures

Baseline Hemoglobin Concentration
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

Baseline Serum Ferritin Concentration
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

First Posted
September 13, 2005
Last Updated
February 29, 2012
Sponsor
Watson Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00224042
Brief Title
Effect of Ferrlecit® Versus Oral Iron on Iron Deficient Chronic Kidney Disease (CKD) Patients Receiving Erythropoietic Agents
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 Being Treated With Erythropoietic Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
May 2005 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Watson Pharmaceuticals

4. Oversight

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 receiving erythropoietic agents, such as Procrit® and Aranesp®.

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, Erythropoietic agents, Sodium Ferric Gluconate, Anemia, Iron-Deficiency/drug therapy/etiology, Kidney Failure, Chronic/blood/complications/therapy, Erythropoietin, Recombinant/adverse effects/therapeutic use

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IV iron
Arm Type
Experimental
Arm Title
oral iron
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Sodium Ferric Gluconate complex in sucrose
Other Intervention Name(s)
Ferrlecit
Intervention Description
Sodium ferric gluconate complex in sucrose, 250 mg IV weekly for 4 doses
Intervention Type
Drug
Intervention Name(s)
Ferrous sulfate tablets
Intervention Description
ferrous sulfate 325 mg three times daily for 6 weeks
Primary Outcome Measure Information:
Title
Baseline Hemoglobin Concentration
Time Frame
Baseline
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
Baseline Serum Ferritin Concentration
Time Frame
Baseline
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 Receiving therapy with erythropoietic agent Exclusion Criteria: Receiving dialysis Known sensitivity to Ferrlecit® or any of its components Clinically unstable
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adel R Rizkala, PharmD, MS
Organizational Affiliation
Watson Laboratories, Inc.
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
Country
United States
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
St. Louis
State/Province
Missouri
Country
United States
City
Bronx
State/Province
New York
Country
United States
City
Detroit
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

Learn more about this trial

Effect of Ferrlecit® Versus Oral Iron on Iron Deficient Chronic Kidney Disease (CKD) Patients Receiving Erythropoietic Agents

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