Changes in Iron Markers Following Iron Loading in Hemodialysis Patients

This study has been completed.
Sponsor:
Information provided by:
Papageorgiou General Hospital
ClinicalTrials.gov Identifier:
NCT00308490
First received: March 28, 2006
Last updated: March 12, 2007
Last verified: September 2006
  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: 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

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

No publications provided

ClinicalTrials.gov 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:
Anemia
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Hematologic Diseases
Urologic Diseases
Renal Insufficiency
Ferric oxide, saccharated
Iron
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 16, 2014