Clinical Trials Logo

Clinical Trial Summary

Aim of the work 1. Assessment of hepatic affection in patients with ESRD (end stage renal disease) on regular dialysis with iron indices suggesting iron overload. 2. Comparison between HCV -negative HD patients with high and normal TSAT as regard liver iron concentration(LIC) and degree of fibrosis.


Clinical Trial Description

Anemia is a common complication in patients with chronic kidney disease (CKD) . The main cause of anemia is the inadequate production of erythropoietin. Iron deficiency is another common cause of anemia in these patients . Inflammation is another hallmark of CKD that may lead to a "functional" iron deficient anemia . The first treatment used to correct anemia in CKD patients was blood transfusion. However, the risk of transfusion reaction, transmission of infectious agents and iron overload triggered the search for a better treatment of anemia . Nowadays, the gold standard treatment for anemia in CKD patients is the administration of erythropoiesis stimulating agents (ESAs), associated with iron supplementation . Although the majority of the patients respond to ESA therapy, about 10% of CKD patients are hypo-responsive . One of the causes for hypo-responsiveness to ESAs is iron deficiency, either absolute or functional . A ferritin value lower than 30 ng/mL in men or lower than 15 ng/mL in women are consistent with absolute iron deficiency ; a serum ferritin concentration higher than 300 ng/mL, along with anemia, indicates a functional iron deficiency, as it usually occurs in CKD patients . The "Clinical Practice Guideline for Anemia in Chronic Kidney Disease" from KDIGO stated that CKD patients with anemia should first start iron therapy rather than ESAs . The Dialysis Outcomes and Practice Patterns Study (DOPPS) showed that the number of HD patients with IV iron supplementation increased in most countries and the doses prescribed to these patients also increased in the past 10-15 years. The liver is the main site of iron storage, and the liver iron concentration (LIC) is closely correlated with total body iron stores in patients with secondary forms of hemosiderosis such as thalassemia major, sickle cell disease, and genetic hemochromatosis . Non-invasive techniques for estimating liver iron stores have been developed to avoid liver biopsy, including the superconducting quantum interference device (SQUID), quantitative computed tomography, and MRI . More than one study show that 84% of the HD patients had hepatic iron overload, and in 30% of them iron overload was severe; moreover, iron liver content correlated with infused iron . In spite of the widespread use of IV iron supplementation in HD patients, the safest dosing strategy is still poorly clarified, as well as its relation with serum ferritin levels, iron overload and mortality risk. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05028595
Study type Observational
Source Assiut University
Contact
Status Completed
Phase
Start date January 20, 2019
Completion date December 30, 2020

See also
  Status Clinical Trial Phase
Terminated NCT01325584 - Compassionate Use of Omegaven® in the Treatment of Parenteral Nutrition Induced Hepatic Injury Phase 2
Recruiting NCT01981213 - Attempted Suicide With Acetaminophen Among 8-18 Year-old Children / Adolescents in Denmark N/A