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

Phase 4

Terminated

• Conditions: Anemia
• Interventions: Drug: sodium ferric gluconate; Drug: Oral Iron

• Registration Number: NCT00223938
• Lead Sponsor: Sanofi

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.

Study Timeline

• Study Start: 2003-12-30
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-22
• Primary Completion: 2007-04-27
• Study Completion: 2007-04-27
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-21
• Last Update Posted: 2021-06-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 112

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	sodium ferric gluconate	sodium ferric gluconate
1	Oral Iron	Oral Iron
2	sodium ferric gluconate	sodium ferric gluconate

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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