NCT00298441

Brief Summary

The purpose of this study is to determine whether the frequency of intravenous iron administration has an effect on anemia correction and oxidative stress formation in hemodialysis patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2005

Geographic Reach
1 country

2 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, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 2, 2006

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

May 12, 2008

Status Verified

May 1, 2008

Enrollment Period

11 months

First QC Date

February 28, 2006

Last Update Submit

May 8, 2008

Conditions

Chronic Renal FailureHemodialysisRenal AnemiaIron Deficiency Anemia

Keywords

intravenous iron administration

Outcome Measures

Primary Outcomes (2)

  • hemoglobin levels at 24 weeks

  • oxidized albumin levels at 24 weeks

Interventions

chondroitin sulfate-iron colloidDRUG

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of chronic renal failure
  • Clinical diagnosis of iron deficiency anemia
  • Must be on regular hemodialysis

You may not qualify if:

  • Allergic to intravenous iron administration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Midorigaoka Clinic

Arao, Kumamoto, 864-0033, Japan

Location

Kumamoto University Hospital

Kumamoto, Kumamoto, 860-8556, Japan

Location

Related Publications (1)

  • Anraku M, Kitamura K, Shinohara A, Adachi M, Suenga A, Maruyama T, Miyanaka K, Miyoshi T, Shiraishi N, Nonoguchi H, Otagiri M, Tomita K. Intravenous iron administration induces oxidation of serum albumin in hemodialysis patients. Kidney Int. 2004 Aug;66(2):841-8. doi: 10.1111/j.1523-1755.2004.00813.x.

    PMID: 15253741BACKGROUND

MeSH Terms

Conditions

Kidney Failure, ChronicAnemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsAnemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Kenichiro Kitamura, M.D., Ph.D.

    Kumamoto University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 28, 2006

First Posted

March 2, 2006

Study Start

June 1, 2005

Primary Completion

May 1, 2006

Study Completion

March 1, 2007

Last Updated

May 12, 2008

Record last verified: 2008-05

Locations

JP(2)