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

Anemia Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00223938
• Other study ID #: FR02023
• Status: Terminated
• Phase: Phase 4
• Start date: December 30, 2003
• Est. completion date: April 27, 2007

Study information

• Verified date: June 2021
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 112
• Est. completion date: April 27, 2007
• Est. primary completion date: April 27, 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anemia

Intervention

Drug:
• Oral Iron
Oral Iron
• sodium ferric gluconate
weekly intravenous injection Dose 1
• sodium ferric gluconate
weekly intravenous injection Dose 2

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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