Status:
COMPLETED
2 Doses of Ferrlecit Versus Oral Iron to Treat Iron-deficiency Anemia in Peritoneal Dialysis Patients.
Lead Sponsor:
Watson Pharmaceuticals
Conditions:
Iron Deficiency Anemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT00223977
Start Date
December 1 2003
End Date
February 1 2008
Last Update
July 8 2013
Active Locations (43)
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Birmingham, Alabama, United States
2
Mesa, Arizona, United States
3
Los Angeles, California, United States
4
Torrance, California, United States