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

TerminatedPhase 4

Sponsor: Sanofi

Conditions: Anemia

Interventions: Oral Iron, sodium ferric gluconate, sodium ferric gluconate

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.

Locations (8)

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