NCT00236938

Brief Summary

This is a open-label, prospective study comparing intravenous (IV) iron supplementation to standard care in anemic patents undergoing peritoneal dialysis.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
121

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2002

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

July 1, 2002

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2004

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2004

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

October 10, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 12, 2005

Completed
3.9 years until next milestone

Results Posted

Study results publicly available

September 7, 2009

Completed
Last Updated

May 19, 2021

Status Verified

April 1, 2021

Enrollment Period

2.2 years

First QC Date

October 10, 2005

Results QC Date

January 14, 2009

Last Update Submit

April 29, 2021

Conditions

Anemia

Keywords

ironperitoneal dialysisanemia

Outcome Measures

Primary Outcomes (1)

  • Mean Change From Baseline to the Highest Hemoglobin up to Day 71

    Change from Baseline up to Day 71

Secondary Outcomes (3)

  • The Mean Change From Baseline to the Highest Serum Transferrin Saturation (TSAT) up to Day 71

    Change from Baseline up to Day 71

  • The Mean Change From Baseline to the Highest Ferritin up to Day 71

    Change from Baseline up to Day 71

  • The Mean Change From Baseline to the Highest Reticulocyte Count up to Day 71

    Change from Baseline up to Day 71

Study Arms (2)

Group A

EXPERIMENTAL

Fixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29.

Drug: Venofer and stable erythropoietin (EPO) regimen

Group B

ACTIVE COMPARATOR

Stable erythropoietin (EPO) dose and no supplemental iron.

Drug: stable erythropoietin (EPO) regimen

Interventions

Venofer and stable erythropoietin (EPO) regimenDRUG

Fixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29.

Also known as: Iron Sucrose
Group A
stable erythropoietin (EPO) regimenDRUG

Stable erythropoietin (EPO) dose and no supplemental iron.

Also known as: EPO
Group B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hemoglobin \>= 9.5 and \<= 11.5 g/dL.
  • Ferritin \<= 500 ng/ml.
  • Serum Transferrin Saturation (TSAT) \<= 25%.
  • Stable erythropoietin (EPO) Regimen for 8 weeks.
  • No iron for last 4 weeks before randomization.

You may not qualify if:

  • Known Sensitivity to Iron Sucrose.
  • Suffering concomitant severe diseases of the liver \& cardiovascular system.
  • Pregnancy / Lactation.
  • Inadequate dialysis.
  • Current treatment for asthma.
  • Significant blood loss.
  • Probability of need for transfusion or transfusion within 1 week of enrollment.
  • Anticipated major surgery.
  • Hemochromatosis / hemosiderosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Singh H, Reed J, Noble S, Cangiano JL, Van Wyck DB; United States Iron Sucrose (Venofer) Clinical Trials Group. Effect of intravenous iron sucrose in peritoneal dialysis patients who receive erythropoiesis-stimulating agents for anemia: a randomized, controlled trial. Clin J Am Soc Nephrol. 2006 May;1(3):475-82. doi: 10.2215/CJN.01541005. Epub 2006 Mar 29.

    PMID: 17699248BACKGROUND

MeSH Terms

Conditions

Anemia

Interventions

Ferric Oxide, SaccharatedClinical Protocols

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Ferric CompoundsIron CompoundsInorganic ChemicalsGlucaric AcidSugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydratesTherapeuticsEpidemiologic Study CharacteristicsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and Evaluation

Results Point of Contact

Title
Mark A. Falone, MD
Organization
Luitpold Pharmaceuticals, Inc.
mfalone@luitpold.com
610-650-4200

Study Officials

  • Mark A Falone, MD

    American Regent, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2005

First Posted

October 12, 2005

Study Start

July 1, 2002

Primary Completion

September 1, 2004

Study Completion

October 1, 2004

Last Updated

May 19, 2021

Results First Posted

September 7, 2009

Record last verified: 2021-04