Changes in Iron Markers Following Iron Loading in Hemodia... | NCT00308490

Studies
Changes in Iron Markers Following Iron Loading in Hemodialysis Patients

NCT00308490

Sponsor

Papageorgiou General Hospital

Status

Completed

Last Update Posted

Mar 13, 2007Estimated

Enrollment

160

Phase

Phase 4

Conditions

Anemia in Chronic Renal Disease

Interventions

iron sucrose

Countries

Greece

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2005

Primary Completion Date

Not provided

Completion Date

Jan 2007

First Submitted Date

Mar 28, 2006

First Submission Date that Met QC Criteria

Mar 28, 2006

First Posted Date

Mar 29, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 12, 2007

Last Update Posted Date

Mar 13, 2007Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

160

Name	Type	Description	Arm Group Labels	Other Names
iron sucrose	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ferritin alterations after iron loading at six and twelve weeks from the beginning of iron loading.

Secondary Outcomes

Measure	Description	Time Frame
All iron indices' alterations during twelve weeks from the beginning of iron loading.

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Efstathios Mitsopoulos, MD	Papageorgiou General Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Papageorgiou General Hospital		Thessaloniki		56429	Greece

Intervention Browse Module

MeSH Terms

ID	Term
D000077605	Ferric Oxide, Saccharated

Ancestor Terms

ID	Term
D005290	Ferric Compounds
D058085	Iron Compounds
D007287	Inorganic Chemicals
D005937	Glucaric Acid

Browse Leaves

Not provided

Browse Branches

Not provided