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

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.

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00223938

Enrollment

112

Registered

2005-09-22

Start date

2003-12-30

Completion date

2007-04-27

Last updated

2021-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia

Brief 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.

Detailed description

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.

Interventions

DRUGOral Iron

Oral Iron

DRUGsodium ferric gluconate

weekly intravenous injection Dose 1

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	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

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026