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

June 21, 2021 updated by: Sanofi

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.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

112

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Hot Springs, Arkansas, United States
    • California
      • Orange County, California, United States
      • Simi Valley, California, United States
    • Florida
      • Pembroke Pines, Florida, United States
    • North Carolina
      • Winston-Salem, North Carolina, United States
    • Ohio
      • Canton, Ohio, United States
      • Columbus, Ohio, United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
Oral Iron
Drug: Oral Iron
Oral Iron
Other Names:
  • Ferrous sulfate
EXPERIMENTAL: 2
sodium ferric gluconate
Drug: sodium ferric gluconate
weekly intravenous injection Dose 1
Other Names:
  • Ferrlecit
Drug: sodium ferric gluconate
weekly intravenous injection Dose 2
Other Names:
  • Ferrlecit
EXPERIMENTAL: 3
sodium ferric gluconate
Drug: sodium ferric gluconate
weekly intravenous injection Dose 1
Other Names:
  • Ferrlecit
Drug: sodium ferric gluconate
weekly intravenous injection Dose 2
Other Names:
  • Ferrlecit

What is the study measuring?

Primary Outcome Measures

Outcome 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.
Time Frame: 22 weeks
22 weeks

Secondary Outcome Measures

Outcome 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.
Time Frame: 22 weeks
22 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

  • Study Director: Gary Hoel, RPh, PhD, Watson Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 30, 2003

Primary Completion (ACTUAL)

April 27, 2007

Study Completion (ACTUAL)

April 27, 2007

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (ESTIMATE)

September 22, 2005

Study Record Updates

Last Update Posted (ACTUAL)

June 24, 2021

Last Update Submitted That Met QC Criteria

June 21, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FR02023

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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