Changes in Iron Markers Following Iron Loading in Hemodialysis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00308490
Recruitment Status : Completed
First Posted : March 29, 2006
Last Update Posted : March 13, 2007
Information provided by:
Papageorgiou General Hospital

Brief Summary:
The purpose of this study is to describe alterations of serum ferritin, transferrin saturation, soluble transferrin receptor, % hypochromic erythrocytes, % reticulocytes, reticulocyte hemoglobin content after iron loading in hemodialysis patients.

Condition or disease Intervention/treatment Phase
Anemia in Chronic Renal Disease Drug: iron sucrose Phase 4

Study Type : Interventional  (Clinical Trial)
Enrollment : 160 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Phase IV Study of Iron Indices' Kinetics in Hemodialysis Patients
Study Start Date : September 2005
Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis Iron
U.S. FDA Resources

Primary Outcome Measures :
  1. Ferritin alterations after iron loading at six and twelve weeks from the beginning of iron loading.

Secondary Outcome Measures :
  1. All iron indices' alterations during twelve weeks from the beginning of iron loading.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • hemodialysis for three months minimum
  • stable epoetin dose for two months minimum
  • serum ferritin concentration < 1000 ng/ml
  • transferrin saturation < 50%
  • parathormone concentration < 800 pg/ml

Exclusion Criteria:

  • hemoglobin concentration > 13g/dl
  • serum ferritin concentration < 20 ng/ml
  • vitamin B12 and/or folic deficiency
  • other hematologic disease than anemia
  • cancer
  • hypothyroidism
  • infectious disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00308490

Papageorgiou General Hospital
Thessaloniki, Greece, 56429
Sponsors and Collaborators
Papageorgiou General Hospital
Principal Investigator: Efstathios Mitsopoulos, MD Papageorgiou General Hospital Identifier: NCT00308490     History of Changes
Other Study ID Numbers: 48/31-1-2005
First Posted: March 29, 2006    Key Record Dates
Last Update Posted: March 13, 2007
Last Verified: September 2006

Additional relevant MeSH terms:
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Ferric oxide, saccharated
Trace Elements
Growth Substances
Physiological Effects of Drugs