NCT00223964

Brief Summary

This was a multi-center study in iron-deficient pediatric hemodialysis patients, whose legal guardian had provided signed informed consent and satisfied the inclusion and exclusion criteria.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P25-P50 for phase_4

Geographic Reach
5 countries

24 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

June 1, 2003

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2003

Completed
2 years 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
Last Updated

August 14, 2012

Status Verified

August 1, 2012

Enrollment Period

4 months

First QC Date

September 13, 2005

Last Update Submit

August 10, 2012

Conditions

Anemia

Keywords

Iron DeficiencyAnemia in Pediatric Hemodialysis

Outcome Measures

Primary Outcomes (1)

  • Demonstrate and compare effectiveness of two Ferrlecit® doses in increasing hemoglobin in iron-deficient pediatric hemodialysis patients requiring repletion iron therapy.

    2 weeks

Secondary Outcomes (1)

  • Evaluate single-dose pharmacokinetics of Ferrlecit® in iron deficient pediatric hemodialysis patients and to access the safety profile of Ferrlecit® in pediatric hemodialysis patients.

    48 hours

Study Arms (2)

dose level 1

EXPERIMENTAL

1.5 mg/kg

Drug: Ferrlecit (sodium ferric gluconate complex in sucrose injection)

dose level 2

EXPERIMENTAL

3 mg/kg

Drug: Ferrlecit (sodium ferric gluconate complex in sucrose injection)

Interventions

Ferrlecit (sodium ferric gluconate complex in sucrose injection)DRUG
dose level 1dose level 2

Eligibility Criteria

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

You may qualify if:

  • Male or female pediatric end-stage renal disease (ESRD) patients.
  • Predetermined TSAT and serum ferritin levels
  • Receiving chronic hemodialysis therapy with an identified need for repletion iron therapy.
  • Receiving a stable epoetin (EPO) dosing regimen.

You may not qualify if:

  • Receipt of any form of iron supplements during the 4 weeks prior to the first Ferrlecit® dosing.
  • Blood transfusion.
  • Hypersensitivity to Ferrlecit®.
  • Significant inflammatory conditions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

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

Boston, Massachusetts, United States

Location

Unknown Facility

Kansas City, Missouri, United States

Location

Unknown Facility

The Bronx, New York, United States

Location

Unknown Facility

Seattle, Washington, United States

Location

Unknown Facility

Aruascalientes, Mexico

Location

Unknown Facility

Mexico City, Mexico

Location

Unknown Facility

Bialystok, Poland

Location

Unknown Facility

Gdansk, Poland

Location

Unknown Facility

Krakow, Poland

Location

Unknown Facility

Lodz, Poland

Location

Unknown Facility

Lublin, Poland

Location

Unknown Facility

Szczecin, Poland

Location

Unknown Facility

Torum, Poland

Location

Unknown Facility

Wroclaw, Poland

Location

Unknown Facility

Zabrze, Poland

Location

Unknown Facility

Bashkortostan, Russia

Location

Unknown Facility

Moscow, Russia

Location

Unknown Facility

Saint Petersburg, Russia

Location

Unknown Facility

Tartarstan, Russia

Location

Unknown Facility

Belgrade, Serbia

Location

MeSH Terms

Conditions

AnemiaIron Deficiencies

Interventions

ferric gluconateSucrose

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DisaccharidesOligosaccharidesPolysaccharidesCarbohydratesSugars

Study Officials

  • GARY HOEL, RPh, PhD

    WATSON LPHARMACEUTICAL

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 22, 2005

Study Start

June 1, 2003

Primary Completion

October 1, 2003

Last Updated

August 14, 2012

Record last verified: 2012-08

Locations

ME(2)RU(4)US(8)SE(1)PL(9)