2 Doses of Ferrlecit Versus Oral Iron to Treat Iron-deficiency Anemia in Peritoneal Dialysis Patients.
NCT ID: NCT00223977
Last Updated: 2013-07-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
146 participants
INTERVENTIONAL
2003-12-31
2008-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Sodium ferric gluconate complex 125 mg
125 mg sodium ferric gluconate weekly x 8 weeks
Sodium Ferric Gluconate Complex
125 mg weekly x 8 weeks
Sodium ferric gluconate complex 250 mg
250 mg sodium ferric gluconate complex weekly x 4 weeks
Sodium Ferric Gluconate Complex
250 mg weekly x 4
Oral iron
325 mg ferrous sulfate three times daily x 8 weeks
Oral Iron
325 mg ferrous sulfate orally three times daily x 8 weeks
Interventions
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Sodium Ferric Gluconate Complex
125 mg weekly x 8 weeks
Sodium Ferric Gluconate Complex
250 mg weekly x 4
Oral Iron
325 mg ferrous sulfate orally three times daily x 8 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Watson Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Gary Hoel, RPh, PhD
Role: STUDY_CHAIR
Watson Pharmaceuticals
Locations
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Birmingham, Alabama, United States
Mesa, Arizona, United States
Los Angeles, California, United States
Torrance, California, United States
New Haven, Connecticut, United States
Evanston, Illinois, United States
Shreveport, Louisiana, United States
Springfield, Massachusetts, United States
Worcester, Massachusetts, United States
Royal Oak, Michigan, United States
St Louis, Missouri, United States
New York, New York, United States
Chapel Hill, North Carolina, United States
Winston-Salem, North Carolina, United States
Tulsa, Oklahoma, United States
Philadelphia, Pennsylvania, United States
Sioux Falls, South Dakota, United States
Dallas, Texas, United States
Richmond, Virginia, United States
Sofia, , Bulgaria
Varna, , Bulgaria
Kelowna, , Canada
Kitchener, , Canada
London, , Canada
Scarborough, , Canada
Toronto, , Canada
Zagreb, , Croatia
Bangalore, , India
Chandigarh, , India
Chennai, , India
Hyderabad, , India
Lucknow, , India
Mahīm, , India
New Delhi, , India
Col. Toriello Guerra, , Mexico
Durango, , Mexico
Mexico City, , Mexico
Monterrey, , Mexico
Tlalpan, , Mexico
Zapopan, , Mexico
Osijek, , Poland
Moscow, , Russia
Saint Petersburg, , Russia
Countries
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Other Identifiers
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FR03001
Identifier Type: -
Identifier Source: org_study_id
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