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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-12-30

Study Completion Date

2007-04-27

Brief Summary

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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.

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Detailed Description

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A Multi-Center, Open-Label, Parallel Group Study of the efficacy and safety of Ferrlecit in the Maintenance of Iron Stores and Serum Hemoglobin Concentration in Hemodialysis Patients Receiving Erythropoietin. Patients with normal iron indices receive one of two doses of Ferrlecit administered weekly throughout the treatment period. Efficacy was assesses at designated timepoints throughout the study and after the last Ferrlecit dose.

Conditions

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Anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Oral Iron

Group Type ACTIVE_COMPARATOR

Oral Iron

Intervention Type DRUG

Oral Iron

2

sodium ferric gluconate

Group Type EXPERIMENTAL

sodium ferric gluconate

Intervention Type DRUG

weekly intravenous injection Dose 1

3

sodium ferric gluconate

Group Type EXPERIMENTAL

sodium ferric gluconate

Intervention Type DRUG

weekly intravenous injection Dose 2

Interventions

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Oral Iron

Intervention Type DRUG

sodium ferric gluconate

weekly intravenous injection Dose 1

Intervention Type DRUG

sodium ferric gluconate

weekly intravenous injection Dose 2

Intervention Type DRUG

Other Intervention Names

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Ferrous sulfate Ferrlecit Ferrlecit

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No