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

Completed · Phase 2/Phase 3

Conditions studied: Iron Deficiency Anemia

In brief

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.

Key facts

Study ID

NCT00223977

Run by

Watson Pharmaceuticals

People needed

146

Starts

2003-12-01

Expected to finish

2008-02-01

Last updated by the study team

2013-07-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Mesa, Arizona, United States
• Study site — Los Angeles, California, United States
• Study site — Torrance, California, United States
• Study site — New Haven, Connecticut, United States
• Study site — Evanston, Illinois, United States
• Study site — Shreveport, Louisiana, United States
• Study site — Springfield, Massachusetts, United States
• Study site — Worcester, Massachusetts, United States
• Study site — Royal Oak, Michigan, United States
• Study site — St Louis, Missouri, United States
• Study site — New York, New York, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — Winston-Salem, North Carolina, United States
• Study site — Tulsa, Oklahoma, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Sioux Falls, South Dakota, United States
• Study site — Dallas, Texas, United States
• Study site — Richmond, Virginia, United States
• Study site — Sofia, Bulgaria
• Study site — Varna, Bulgaria
• Study site — Kelowna, Canada
• Study site — Kitchener, Canada
• Study site — London, Canada
• Study site — Scarborough, Canada

Full record on ClinicalTrials.gov

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