Changes in Iron Markers Following Iron Loading in Hemodialysis Patients

This study has been completed.
Information provided by:
Papageorgiou General Hospital Identifier:
First received: March 28, 2006
Last updated: March 12, 2007
Last verified: September 2006

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: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its identifier: NCT00308490

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

No publications provided Identifier: NCT00308490     History of Changes
Other Study ID Numbers: 48/31-1-2005
Study First Received: March 28, 2006
Last Updated: March 12, 2007
Health Authority: Greece: Ministry of Health and Welfare

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Urologic Diseases processed this record on October 21, 2014