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- Essai clinique NCT05028595
Evaluation of Hepatic Affection in Hemodialysis Patients With Iron Overload in Assiut University Hospital
Aim of the work
- Assessment of hepatic affection in patients with ESRD (end stage renal disease) on regular dialysis with iron indices suggesting iron overload.
- Comparison between HCV -negative HD patients with high and normal TSAT as regard liver iron concentration(LIC) and degree of fibrosis.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Assuit, Egypte, 71511
- Marwa Abokresha
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Eighty patients with end-stage kidney disease (ESKD) on regular hemodialysis for more than two years were enrolled in the study with normal serum ferritin level at the start of dialysis
Exclusion Criteria:
- Patients with one or more of the following conditions were excluded; non-dialysis-dependent chronic kidney disease patients (NDD-CKD), iron deficiency anaemia (diagnosed based on iron studies included serum iron, ferritin and total iron binding capacity), other causes of hemochromatosis such as genetic type, or hemochromatosis secondary to hemolytic anemia, hepatitis B virus infection, and human immunodeficiency virus infection. Moreover, patients with additional causes of liver disease, including non-alcoholic fatty liver disease, primary sclerosing cholangitis, primary biliary cholangitis, etc. were excluded.
Other exclusion criteria included active malignancy, heart failure, use of immunosuppressive drugs, previous liver transplantation, and patients who are below 18 year of age
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Assessment of hepatic affection in patients with ESRD (end stage renal disease) on regular dialysis with iron indices suggesting iron overload.
Délai: Baseline
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MRI for abdomen was done .patient on supine position and multiple cuts were taken
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Baseline
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Comparison between HCV -negative HD patients with high and normal TSAT as regard liver iron concentration(LIC) and degree of fibrosis.
Délai: Baseline
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Assesment of degree of hepatic fibrosis by fibroscan machine ,Patients on supine position and sonar probe placed between ribs9-11 to asses degree of fibrosis
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Baseline
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Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Publications générales
- National Kidney Foundation. K/DOQI clinical practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Am J Kidney Dis. 2002 Feb;39(2 Suppl 1):S1-266. No abstract available.
- Stauffer ME, Fan T. Prevalence of anemia in chronic kidney disease in the United States. PLoS One. 2014 Jan 2;9(1):e84943. doi: 10.1371/journal.pone.0084943. eCollection 2014.
- Ribeiro S, Belo L, Reis F, Santos-Silva A. Iron therapy in chronic kidney disease: Recent changes, benefits and risks. Blood Rev. 2016 Jan;30(1):65-72. doi: 10.1016/j.blre.2015.07.006. Epub 2015 Aug 18.
- Nangaku M, Eckardt KU. Pathogenesis of renal anemia. Semin Nephrol. 2006 Jul;26(4):261-8. doi: 10.1016/j.semnephrol.2006.06.001.
- Costa E, Lima M, Alves JM, Rocha S, Rocha-Pereira P, Castro E, Miranda V, do SF, Loureiro A, Quintanilha A, Belo L, Santos-Silva A. Inflammation, T-cell phenotype, and inflammatory cytokines in chronic kidney disease patients under hemodialysis and its relationship to resistance to recombinant human erythropoietin therapy. J Clin Immunol. 2008 May;28(3):268-75. doi: 10.1007/s10875-007-9168-x.
- do Sameiro-Faria M, Ribeiro S, Costa E, Mendonca D, Teixeira L, Rocha-Pereira P, Fernandes J, Nascimento H, Kohlova M, Reis F, Amado L, Bronze-da-Rocha E, Miranda V, Quintanilha A, Belo L, Santos-Silva A. Risk factors for mortality in hemodialysis patients: two-year follow-up study. Dis Markers. 2013;35(6):791-8. doi: 10.1155/2013/518945. Epub 2013 Nov 24.
- Lukaszyk E, Lukaszyk M, Koc-Zorawska E, Tobolczyk J, Bodzenta-Lukaszyk A, Malyszko J. Iron Status and Inflammation in Early Stages of Chronic Kidney Disease. Kidney Blood Press Res. 2015;40(4):366-73. doi: 10.1159/000368512. Epub 2015 Jun 20.
- Ibrahim HN, Ishani A, Guo H, Gilbertson DT. Blood transfusion use in non-dialysis-dependent chronic kidney disease patients aged 65 years and older. Nephrol Dial Transplant. 2009 Oct;24(10):3138-43. doi: 10.1093/ndt/gfp213. Epub 2009 May 18.
- Drueke TB, Parfrey PS. Summary of the KDIGO guideline on anemia and comment: reading between the (guide)line(s). Kidney Int. 2012 Nov;82(9):952-60. doi: 10.1038/ki.2012.270. Epub 2012 Aug 1.
- Kuwahara M, Mandai S, Kasagi Y, Kusaka K, Tanaka T, Shikuma S, Akita W. Responsiveness to erythropoiesis-stimulating agents and renal survival in patients with chronic kidney disease. Clin Exp Nephrol. 2015 Aug;19(4):598-605. doi: 10.1007/s10157-014-1023-9. Epub 2014 Sep 3.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Hepatic MRI
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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Essais cliniques sur Lésion hépatique
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Kessler FoundationInstituto Vocacional Enrique Díaz de León A.C., Guadalajara, MexicoRecrutementTBI (Traumatic Brain Injury) ou MS (Sclérose en Plaques)États-Unis, Espagne