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Changes in Iron Markers Following Iron Loading in Hemodialysis Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00308490
First Posted: March 29, 2006
Last Update Posted: March 13, 2007
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.
Information provided by:
Papageorgiou General Hospital
  Purpose
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 Intervention Phase
Anemia in Chronic Renal Disease Drug: iron sucrose Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Papageorgiou General Hospital:

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

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

Estimated Enrollment: 160
Study Start Date: September 2005
Estimated Study Completion Date: January 2007
  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00308490


Locations
Greece
Papageorgiou General Hospital
Thessaloniki, Greece, 56429
Sponsors and Collaborators
Papageorgiou General Hospital
Investigators
Principal Investigator: Efstathios Mitsopoulos, MD Papageorgiou General Hospital
  More Information

ClinicalTrials.gov Identifier: NCT00308490     History of Changes
Other Study ID Numbers: 48/31-1-2005
First Submitted: March 28, 2006
First Posted: March 29, 2006
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
Iron
Ferric oxide, saccharated
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hematinics