Changes in Iron Markers Following Iron Loading in Hemodialysis Patients

This study has been completed.

Sponsored by:	Papageorgiou General Hospital
Information provided by:	Papageorgiou General Hospital
ClinicalTrials.gov Identifier:	NCT00308490

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 IV

MedlinePlus related topics: Dialysis Kidney Failure

Drug Information available for: Sucrose Ferric oxide, saccharated

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title:	Phase IV Study of Iron Indices' Kinetics in Hemodialysis Patients

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

Study ID Numbers:	48/31-1-2005
Study First Received:	March 28, 2006
Last Updated:	March 12, 2007
ClinicalTrials.gov Identifier:	NCT00308490
Health Authority:	Greece: Ministry of Health and Welfare

Study placed in the following topic categories:

Ferric oxide, saccharated
Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic
Anemia

Kidney Failure, Chronic
Kidney Diseases
Iron
Kidney Failure

Additional relevant MeSH terms:

Hematinics
Therapeutic Uses
Hematologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009