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

Study Overview
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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.

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.

Official Title
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A Multi-center, Open-label, Randomized, 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.

Conditions
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Anemia

Intervention / Treatment
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* Drug: Oral Iron
* Drug: sodium ferric gluconate
* Drug: sodium ferric gluconate


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Oral Iron | Drug: Oral Iron<br>* Oral Iron<br>* Other names: Ferrous sulfate;|
| Experimental: 2<br>sodium ferric gluconate | Drug: sodium ferric gluconate<br>* weekly intravenous injection Dose 1<br>* Other names: Ferrlecit;|
| Experimental: 3<br>sodium ferric gluconate | Drug: sodium ferric gluconate<br>* weekly intravenous injection Dose 2<br>* Other names: Ferrlecit;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective of this study is to evaluate the efficacy of two dose levels of Ferrlecit when compared with oral iron when administered as maintenance therapy in iron-replete hemodialysis patients who are receiving Erythropoietin. |  | 22 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary objectives of this study include comparisons between Ferrlecit treatments to oral iron regarding changes from baseline in hematological parameters, iron indices, EPO requirements and safety. |  | 22 weeks |