NCT00223977

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

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.

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 146 (actual)
• Sponsor: Watson Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Iron Deficiency Anemia

Interventions

Type	Name	Description
DRUG	Sodium Ferric Gluconate Complex	125 mg weekly x 8 weeks
DRUG	Sodium Ferric Gluconate Complex	250 mg weekly x 4
DRUG	Oral Iron	325 mg ferrous sulfate orally three times daily x 8 weeks

Timeline

• Start date: 2003-12-01
• Primary completion: 2004-11-01
• Completion: 2008-02-01
• First posted: 2005-09-22
• Last updated: 2013-07-08
• Results posted: 2009-09-28

Locations

43 sites across 8 countries: United States, Bulgaria, Canada, Croatia, India, Mexico, Poland, Russia