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

Stopped early · Phase 4

Conditions studied: Anemia

In brief

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.

Key facts

Study ID

NCT00223938

Run by

Sanofi

People needed

112

Starts

2003-12-30

Expected to finish

2007-04-27

Last updated by the study team

2021-06-24

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Study site — Hot Springs, Arkansas, United States
• Study site — Orange County, California, United States
• Study site — Simi Valley, California, United States
• Study site — Pembroke Pines, Florida, United States
• Study site — Winston-Salem, North Carolina, United States
• Study site — Canton, Ohio, United States
• Study site — Columbus, Ohio, United States
• Study site — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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