NCT00224003

Brief Summary

A phase 4 clinical investigation in iron-replete pediatric hemodialysis patients, whose legal guardian had provided signed informed consent, and who had satisfied the inclusion and exclusion criteria of the study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2003

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2004

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
4 years until next milestone

Results Posted

Study results publicly available

September 28, 2009

Completed
Last Updated

September 28, 2009

Status Verified

August 1, 2009

Enrollment Period

11 months

First QC Date

September 13, 2005

Results QC Date

August 18, 2009

Last Update Submit

August 18, 2009

Conditions

Anemia

Keywords

Anemia

Outcome Measures

Primary Outcomes (2)

  • Serum Ferritin

    Change from baseline to 2 weeks after last Fe dose

    14 weeks

  • Transferrin Saturation

    Change from baseline to 2 weeks after last dose

    14 weeks

Secondary Outcomes (1)

  • Evaluate the Effect of Intravenous Administration of Ferrlecit on Hematology Parameteres, on EPO Dose, and Safety.

    14 weeks

Interventions

Sodium Ferric Gluconate Complex in Sucrose.DRUG

Eligibility Criteria

Age2 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Male or female pediatric ESRD, Patients \>\_ 2 and \<\_ 16 years of age, whose legally authorized representative provided signed informed consent.
  • Stabilized on chronic hemodialysis therapy with an identified need for maintenance iron therapy.
  • Predetermined TSAT and serum Ferritin (at the screening visit).
  • Receiving a stable EPO dosing regimen.

You may not qualify if:

  • Receipt of any form of iron supplementation during the 2 weeks prior to the first Ferrlecit dosing.
  • Hypersensitivity to Ferrlecit or any of its inactive components.
  • High TSAT level.
  • High Serum Ferritin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Unknown Facility

Birmingham, Alabama, United States

Location

Unknown Facility

Los Angeles, California, United States

Location

Unknown Facility

San Diego, California, United States

Location

Unknown Facility

Stanford, California, United States

Location

Unknown Facility

Atlanta, Georgia, United States

Location

Unknown Facility

Boston, Massachusetts, United States

Location

Unknown Facility

Kansas City, Missouri, United States

Location

Unknown Facility

The Bronx, New York, United States

Location

Unknown Facility

Dallas, Texas, United States

Location

Unknown Facility

Seattle, Washington, United States

Location

Related Publications (1)

  • Warady BA, Zobrist RH, Finan E; Ferrlecit Pediatric Study Group. Sodium ferric gluconate complex maintenance therapy in children on hemodialysis. Pediatr Nephrol. 2006 Apr;21(4):553-60. doi: 10.1007/s00467-006-0042-5. Epub 2006 Mar 7.

    PMID: 16520948RESULT

MeSH Terms

Conditions

Anemia

Interventions

ferric gluconateSucrose

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

DisaccharidesOligosaccharidesPolysaccharidesCarbohydratesSugars

Results Point of Contact

Title
Gary Hoel, RPh, PhD
Organization
Watson Laboratories, Inc
gary.hoel@watson.com
801-588-6641

Study Officials

  • Gary Hoel, RPh, PhD

    Watson Laboratories, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 22, 2005

Study Start

April 1, 2003

Primary Completion

March 1, 2004

Study Completion

February 1, 2005

Last Updated

September 28, 2009

Results First Posted

September 28, 2009

Record last verified: 2009-08

Locations

US(10)