NCT01169961

Brief Summary

The purpose of the present study is to evaluate in hemodialysis patients, who have elevated serum ferritin ( \>2000ng/ml) and transferrin saturation (TSAT) \>30%, iron deposition in the heart, pancreas, liver and spleen using the T2\* MRI technique. In addition, we will also measure the free iron forms in the plasma and LPI, LCI in red blood cells, platelets and PMN, in addition to serum hepcidin, TSAT, serum ferritin, CRP and oxidative stress parameters (ROS,GSH, and malonyldialdehyde (MDA).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 26, 2010

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

July 26, 2010

Status Verified

July 1, 2010

Enrollment Period

6 months

First QC Date

July 23, 2010

Last Update Submit

July 23, 2010

Conditions

Iron Overload

Keywords

IRON OVERLOAD IN HEMODIALYSIS PATIENTS

Outcome Measures

Primary Outcomes (1)

  • T2*MRI (magnetic resonance imaging)

    This method is commonly used to evaluate and monitor iron deposition in major organs (iron overload) in hemodialysis patients with end stage renal failure

    one year

Secondary Outcomes (1)

  • Iron parameters (FERRITIN, TRANSFERREN SAT ,LPI HEPCIDIN,LCI,CRP,OXIDATIVE STRESS PARAMETERS(ROS,GSH,MDA)

    ONE YEAR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

hemodialysis patients, who have elevated serum ferritin ( \>2000ng/ml) and transferrin saturation (TSAT) \>30%

You may qualify if:

  • patients for study are \> 50 years of age,
  • on chronic hemodialysis for at least one year,
  • with serum ferritin levels \> 2000 ng/ml and TSAT \> 30%.

You may not qualify if:

  • malignancies,
  • any active infection requiring systemic antibiotic therapy, and
  • hospitalization within the two weeks before screening.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wolfsson Medical Center

Holon, Israel, Israel

RECRUITING

MeSH Terms

Conditions

Iron Overload

Condition Hierarchy (Ancestors)

Iron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • GHOTI HOSSAM

    HEMATOLOGY DEPARTMENT ON WOLFSSON MEDICAL CENTER

    PRINCIPAL INVESTIGATOR

Central Study Contacts

GHOTI HOSSAM

CONTACT

035028110drghoti123@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

July 23, 2010

First Posted

July 26, 2010

Study Start

February 1, 2010

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

July 26, 2010

Record last verified: 2010-07

Locations

IL(1)