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2 Doses of Ferrlecit Versus Oral Iron to Treat Iron-deficiency Anemia in Peritoneal Dialysis Patients.

Primary Purpose

Iron Deficiency Anemia

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Sodium Ferric Gluconate Complex
Sodium Ferric Gluconate Complex
Oral Iron
Sponsored by
Watson Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Iron Deficiency Anemia focused on measuring Anemia.

Eligibility Criteria

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

Inclusion Criteria: Male or female, at least 18 years of age. Received maintenance peritoneal dialysis therapy for at least 4 weeks. Was expected to remain on peritoneal dialysis therapy for duration of study. Had predetermined low hemoglobin and transferrin saturation (TSAT) levels. Signed patient informed consent. Exclusion Criteria: Had a predetermined serum levels of Ferritin and TSAT Pregnant or lactating. Had a serious concomitant medical disorder incompatible with participation in the study. Had a known hypersensitivity to Ferrlecit or any of its components. Unable to cooperate or comply with the protocol.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Sodium ferric gluconate complex 125 mg

Sodium ferric gluconate complex 250 mg

Oral iron

Arm Description

125 mg sodium ferric gluconate weekly x 8 weeks

250 mg sodium ferric gluconate complex weekly x 4 weeks

325 mg ferrous sulfate three times daily x 8 weeks

Outcomes

Primary Outcome Measures

Hemoglobin
Change from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection

Secondary Outcome Measures

Change From Baseline in Hematocrit (Hct)
Change from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection
Change From Baseline in Transferrin Saturation (TSAT).
Change from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection
Change From Baseline in Serum Ferritin.
Change from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection
Responders by Treatment Group
Patients were classified as responders to treatment if they had an increase in Hgb of at least 1.0 g/dL assessed at 2 weeks following the final administration of Ferrlecit or 1 week following the last dose of oral iron.

Full Information

First Posted
September 13, 2005
Last Updated
May 17, 2013
Sponsor
Watson Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00223977
Brief Title
2 Doses of Ferrlecit Versus Oral Iron to Treat Iron-deficiency Anemia in Peritoneal Dialysis Patients.
Official Title
A Multi-center, Randomized, Open Label Study of the Efficacy and Safety of Two Doses of Ferrlecit Versus Oral Iron to Treat Iron-deficiency Anemia in Peroneal Dialysis Patients Receiving Erythropoietin.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
November 2004 (Actual)
Study Completion Date
February 2008 (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 is a phase 3 clinical investigation. Patients who meet the eligibility criteria and provide signed informed consent will be randomized to receive one of two levels of Ferrlecit or oral iron in a 1:1:1 ratio.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency Anemia
Keywords
Anemia.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
146 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sodium ferric gluconate complex 125 mg
Arm Type
Experimental
Arm Description
125 mg sodium ferric gluconate weekly x 8 weeks
Arm Title
Sodium ferric gluconate complex 250 mg
Arm Type
Experimental
Arm Description
250 mg sodium ferric gluconate complex weekly x 4 weeks
Arm Title
Oral iron
Arm Type
Active Comparator
Arm Description
325 mg ferrous sulfate three times daily x 8 weeks
Intervention Type
Drug
Intervention Name(s)
Sodium Ferric Gluconate Complex
Other Intervention Name(s)
Ferrlecit
Intervention Description
125 mg weekly x 8 weeks
Intervention Type
Drug
Intervention Name(s)
Sodium Ferric Gluconate Complex
Other Intervention Name(s)
Ferrlecit
Intervention Description
250 mg weekly x 4
Intervention Type
Drug
Intervention Name(s)
Oral Iron
Intervention Description
325 mg ferrous sulfate orally three times daily x 8 weeks
Primary Outcome Measure Information:
Title
Hemoglobin
Description
Change from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection
Time Frame
Baseline to 5 weeks and 9 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in Hematocrit (Hct)
Description
Change from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection
Time Frame
Baseline to 5 weeks and 9 weeks
Title
Change From Baseline in Transferrin Saturation (TSAT).
Description
Change from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection
Time Frame
Baseline to 5 weeks and 9 weeks
Title
Change From Baseline in Serum Ferritin.
Description
Change from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection
Time Frame
Baseline to 5 weeks and 9 weeks
Title
Responders by Treatment Group
Description
Patients were classified as responders to treatment if they had an increase in Hgb of at least 1.0 g/dL assessed at 2 weeks following the final administration of Ferrlecit or 1 week following the last dose of oral iron.
Time Frame
Baseline to 5 weeks and 9 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female, at least 18 years of age. Received maintenance peritoneal dialysis therapy for at least 4 weeks. Was expected to remain on peritoneal dialysis therapy for duration of study. Had predetermined low hemoglobin and transferrin saturation (TSAT) levels. Signed patient informed consent. Exclusion Criteria: Had a predetermined serum levels of Ferritin and TSAT Pregnant or lactating. Had a serious concomitant medical disorder incompatible with participation in the study. Had a known hypersensitivity to Ferrlecit or any of its components. Unable to cooperate or comply with the protocol.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary Hoel, RPh, PhD
Organizational Affiliation
Watson Pharmaceuticals
Official's Role
Study Chair
Facility Information:
City
Birmingham
State/Province
Alabama
Country
United States
City
Mesa
State/Province
Arizona
Country
United States
City
Los Angeles
State/Province
California
Country
United States
City
Torrance
State/Province
California
Country
United States
City
New Haven
State/Province
Connecticut
Country
United States
City
Evanston
State/Province
Illinois
Country
United States
City
Shreveport
State/Province
Louisiana
Country
United States
City
Springfield
State/Province
Massachusetts
Country
United States
City
Worcester
State/Province
Massachusetts
Country
United States
City
Royal Oak
State/Province
Michigan
Country
United States
City
St. Louis
State/Province
Missouri
Country
United States
City
New York
State/Province
New York
Country
United States
City
Chapel Hill
State/Province
North Carolina
Country
United States
City
Winston-salem
State/Province
North Carolina
Country
United States
City
Tulsa
State/Province
Oklahoma
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
Sioux Falls
State/Province
South Dakota
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
Richmond
State/Province
Virginia
Country
United States
City
Sofia
Country
Bulgaria
City
Varna
Country
Bulgaria
City
Kelowna
Country
Canada
City
Kitchener
Country
Canada
City
London
Country
Canada
City
Scarborough
Country
Canada
City
Toronto
Country
Canada
City
Zagreb
Country
Croatia
City
Bangalore
Country
India
City
Chandigarh
Country
India
City
Chennai
Country
India
City
Hyderabad
Country
India
City
Lucknow
Country
India
City
Mahim
Country
India
City
New Delhi
Country
India
City
Col. Toriello Guerra
Country
Mexico
City
Durango
Country
Mexico
City
Mexico City
Country
Mexico
City
Monterrey
Country
Mexico
City
Tlalpan
Country
Mexico
City
Zapopan
Country
Mexico
City
Osijek
Country
Poland
City
Moscow
Country
Russian Federation
City
St. Petersburg
Country
Russian Federation

12. IPD Sharing Statement

Learn more about this trial

2 Doses of Ferrlecit Versus Oral Iron to Treat Iron-deficiency Anemia in Peritoneal Dialysis Patients.

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