Evaluation of Hepatic Affection in Hemodialysis Patients With Iron Overload in Assiut University Hospital

NCT05028595 | Completed

• 1 other identifier: Hepatic MRI
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of the work

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

Conditions

Hepatic Injury

Outcome Measures

Primary Outcomes (1)

• Assessment of hepatic affection in patients with ESRD (end stage renal disease) on regular dialysis with iron indices suggesting iron overload.

  MRI for abdomen was done .patient on supine position and multiple cuts were taken

  Baseline

Secondary Outcomes (1)

• Comparison between HCV -negative HD patients with high and normal TSAT as regard liver iron concentration(LIC) and degree of fibrosis.

  Baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

PT with ESRD on regular haemodialysis

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Marwa Abokresha

Asyut, 71511, Egypt

Location

Related Publications (10)

• 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.

  PMID: 24392162 BACKGROUND

• 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.

  PMID: 26342303 BACKGROUND

• Nangaku M, Eckardt KU. Pathogenesis of renal anemia. Semin Nephrol. 2006 Jul;26(4):261-8. doi: 10.1016/j.semnephrol.2006.06.001.

  PMID: 16949463 BACKGROUND

• 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.

  PMID: 18205031 BACKGROUND

• 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.

  PMID: 24347799 BACKGROUND

• 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.

  PMID: 26160488 BACKGROUND

• 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.

  PMID: 19451656 BACKGROUND

• 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.

  PMID: 22854645 BACKGROUND

• 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.

  PMID: 25183365 BACKGROUND

• 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.

  PMID: 11904577 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: August 25, 2021
• First Posted: August 31, 2021
• Study Start: January 20, 2019
• Primary Completion: January 30, 2020
• Study Completion: December 30, 2020
• Last Updated: August 31, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)