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Changes in Iron Markers Following Iron Loading in Hemodialysis Patients

Primary Purpose

Anemia in Chronic Renal Disease

Status

Completed

Phase

Phase 4

Locations

Greece

Study Type

Interventional

Intervention

iron sucrose

About this trial

This is an interventional diagnostic trial for Anemia in Chronic Renal Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Papageorgiou General Hospital

Outcomes

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.

Full Information

NCT ID

NCT00308490

First Posted

March 28, 2006

Last Updated

March 12, 2007

Sponsor

Papageorgiou General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00308490

Brief Title

Changes in Iron Markers Following Iron Loading in Hemodialysis Patients

Official Title

Phase IV Study of Iron Indices' Kinetics in Hemodialysis Patients

Study Type

Interventional

2. Study Status

Record Verification Date

September 2006

Overall Recruitment Status

Completed

Study Start Date

September 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

January 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Papageorgiou General Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anemia in Chronic Renal Disease

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

160 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

iron sucrose

Primary Outcome Measure Information:

Title

Ferritin alterations after iron loading at six and twelve weeks from the beginning of iron loading.

Secondary Outcome Measure Information:

Title

All iron indices' alterations during twelve weeks from the beginning of iron loading.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Efstathios Mitsopoulos, MD

Organizational Affiliation

Papageorgiou General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Papageorgiou General Hospital

City

Thessaloniki

ZIP/Postal Code

56429

Country

Greece

12. IPD Sharing Statement

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Changes in Iron Markers Following Iron Loading in Hemodialysis Patients

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