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

• Status: Completed
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Watson Pharmaceuticals
• Treatments: Ferric Compounds; Ferric gluconate; Iron

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.