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

NCT00223938 | Terminated Phase 4

• 1 other identifier: FR02023
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 8

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.

Conditions

Anemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (3)

1

ACTIVE COMPARATOR

Oral Iron

Drug: Oral Iron

2

EXPERIMENTAL

sodium ferric gluconate

Drug: sodium ferric gluconate

3

EXPERIMENTAL

sodium ferric gluconate

Drug: sodium ferric gluconate

Interventions

Oral Iron DRUG

Oral Iron

Also known as: Ferrous sulfate

1

sodium ferric gluconate DRUG

weekly intravenous injection Dose 1

Also known as: Ferrlecit

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (8)

Unknown Facility

Hot Springs, Arkansas, United States

Location

Unknown Facility

Orange County, California, United States

Location

Unknown Facility

Simi Valley, California, United States

Location

Unknown Facility

Pembroke Pines, Florida, United States

Location

Unknown Facility

Winston-Salem, North Carolina, United States

Location

Unknown Facility

Canton, Ohio, United States

Location

Unknown Facility

Columbus, Ohio, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, United States

Location

MeSH Terms

Conditions

Anemia

Interventions

Iron; ferrous sulfate; ferric gluconate

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• Gary Hoel, RPh, PhD

  Watson Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 22, 2005
• Study Start: December 30, 2003
• Primary Completion: April 27, 2007
• Study Completion: April 27, 2007
• Last Updated: June 24, 2021

Record last verified: 2021-06

Locations

US (8)