Study of the Efficacy and Safety of Ferrlecit in the Maintenance Dosing in Hemodialysis Patients.

• Status: Terminated
• Trial end date: 2007-04-27
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase 4 clinical investigation of the efficacy and safety of Ferrlecit in the maintenance of iron stores and serum hemoglobin concentration in hemodialysis patients receiving Erythropoietin.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Male of female, 18 years old or older.

• Have been receiving chronic hemodialysis therapy

• On stable EPO dosing regimen.

• Have signed patient informed consent.

• Predetermined serum ferritin and TSAT levels.

• Clinical instability - inability to achieve adequate dialysis, abnormal serum albumin and serum glucose.

• Pregnant or lactating.

• A known sensitivity to Ferrlecit

Exclusion Criteria:

• Scheduled for renal transplant.

• A serious concomitant medical disorders incompatible with participation in the study.

• Unable to cooperate or comply with the protocol.

• Use of any investigation agent within 30 days prior to study or during the course of the study.

• Judged by the investigator as unsuitable for enrollment for any reason.