Assessment of Iron Deposition in Major Organs of Hemodialysis Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Wolfson Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Wolfson Medical Center
ClinicalTrials.gov Identifier:
NCT01169961
First received: July 23, 2010
Last updated: NA
Last verified: July 2010
History: No changes posted
  Purpose

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).


Condition
Iron Overload

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Assessment of Iron Deposition in Major Organs of Hemodialysis Patients, Using T2*MRI and Novel Biomarkers of Free Iron Species

Resource links provided by NLM:


Further study details as provided by Wolfson Medical Center:

Primary Outcome Measures:
  • T2*MRI (magnetic resonance imaging) [ Time Frame: one year ] [ Designated as safety issue: No ]
    This method is commonly used to evaluate and monitor iron deposition in major organs (iron overload) in hemodialysis patients with end stage renal failure


Secondary Outcome Measures:
  • Iron parameters (FERRITIN, TRANSFERREN SAT ,LPI HEPCIDIN,LCI,CRP,OXIDATIVE STRESS PARAMETERS(ROS,GSH,MDA) [ Time Frame: ONE YEAR ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 20
Study Start Date: February 2010
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Detailed Description:

Despite the foregoing advances in the management of anemia associated with chronic kidney disease by the use of erythropoiesis stimulating agents and intravenous iron, assessment of iron status in these patients remains an unresolved issue.

It is estimated that following administration of erythropoietin together with intravenous iron, nearly 50% of all hemodialysis patients in the United states have a serum ferritin >500ng/ml (1). However, in many patients high serum ferritin levels (>2000ng/ml) have been documented. These levels are indicative of iron overload, also defined as hemosiderosis (2).

The risk of using IV iron in spite of serum ferritin levels of >2000ng/ml can result in accumulation of excess iron in tissues, such as the heart, liver, and pancreas similar to findings in patients with hemochromatosis (3) with possible deleterious effects. Accordingly, a recent study indicated a mathematically significant correlation between serum ferritin and liver iron stores using the indirect imaging known as SQUID (4).

Recently, T2*MRI (magnetic resonance imaging) became a non-invasive modality for evaluating tissue iron stores (5). Since high iron content shortens the T2* relaxation, decreased T2* values have been advocated as an early marker of iron deposition in target organs, related to the paramagnetic properties of hemosiderosis (5). This method is commonly used to evaluate and monitor iron deposition in major organs in thalassemia major and myelodysplastic syndrome (MDS) who are multitransfused.

In the former diseases, one of the consequences of iron overload is the presence of labile iron forms, which are redox active and therefore are associated with the propensity to catalyze the generation of reactive oxygen species (ROS) by the Haber Weiss reaction .Two forms of labile iron have been identified, one in the plasma (Labile plasma iron-LPI) and the other is found in the cells (labile cellular iron -LCI)(6,7 ).

In iron overload syndromes such as hemochromatosis, thalassemia or MDS these labile iron forms are increased, causing increased generation of oxidative stress with subsequent damage to membrane, cytoplasmatic and nuclear components.

An important master regulator of iron hemostasis is hepcidin, which is liver derived acute phase protein, and its synthesis is regulated by cytokines and iron status in the body (8).

It has been suggested that increased hepcidin levels may also contribute significantly to the severity of anemia of CKD.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • 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%.

Exclusion Criteria:

  • malignancies,
  • any active infection requiring systemic antibiotic therapy, and
  • hospitalization within the two weeks before screening.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01169961

Contacts
Contact: GHOTI HOSSAM 035028110 drghoti123@yahoo.com

Locations
Israel
Wolfsson Medical Center Recruiting
Holon, Israel
Contact: GHOTI HOSSAM    970-35028110    drghoti123@yahoo.com   
Sponsors and Collaborators
Wolfson Medical Center
Investigators
Principal Investigator: GHOTI HOSSAM HEMATOLOGY DEPARTMENT ON WOLFSSON MEDICAL CENTER
  More Information

No publications provided

Responsible Party: Prof. E. Rachmilewitz, Head of Hematology in Wolfson Medical Center
ClinicalTrials.gov Identifier: NCT01169961     History of Changes
Other Study ID Numbers: 0003-10CTIL
Study First Received: July 23, 2010
Last Updated: July 23, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Wolfson Medical Center:
IRON OVERLOAD IN HEMODIALYSIS PATIENTS

Additional relevant MeSH terms:
Iron Overload
Iron Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 26, 2014