Impact of Dialysis Modality on Hepcidin and Iron Metabolism

Overview

– Dialysis modality may influence the oxidative stress and proinflammatory cytokines in ESRD patients. – Dialysis modality may affect hepcidin – Dialysis modality may influence iron and ESA requirements.

Full Title of Study: “A Prospective, Multicenter, Observational Study to Evaluate the Impact of Peritoneal Dialysis Compared With Hemodialysis on Iron Metabolism and Hepcidin”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: February 2016

Detailed Description

It has been considered that PD patients tended to be less anemic and require lower ESA dose than HD patients. In addition, it was also known that the level of oxidative stress and inflammatory cytokines tended to be lower in PD patients than HD patients. And hepcidin synthesis is markedly increased during inflammation. Altogether, Lower ESA requirement in PD patients may be associated with lower hepcidin level due to lower inflammatory state compared with HD patients.

Arms, Groups and Cohorts

  • Peritoneal dialysis
    • start PD
  • Hemodialysis
    • start HD

Clinical Trial Outcome Measures

Primary Measures

  • ESA (Erythrocyte stimulating agents) dose
    • Time Frame: six months
    • We will compare ESA dose between PD patients and HD patients

Secondary Measures

  • IV iron treatment (% of patients)
    • Time Frame: six months
    • We will compare IV iron treatment (% of patients) between PD patients and HD patients
  • Hepcidin level
    • Time Frame: six months
    • We will compare hepcidin level between PD patients and HD patients
  • hs-CRP
    • Time Frame: six months
    • We will compare hs-CRP level between PD patients and HD patients
  • Myeloperoxidase
    • Time Frame: six months
    • We will compare myeloperoxidase between PD patients and HD patients
  • Transfusion rate
    • Time Frame: six months
    • We will compare transfusion rate ( % of patients) between PD patients and HD patients
  • TNF-a
    • Time Frame: six months
    • We will compare TNF-a between PD patients and HD patients
  • IL-6
    • Time Frame: six months
    • We will compare IL-6 between PD patients and HD patients
  • Total antioxidant capacity
    • Time Frame: six months
    • We will compare total antioxidant capacity between PD patients and HD patients

Participating in This Clinical Trial

Inclusion Criteria

  • Written informed consent – Age 18 years or older – Dialysis treatment was expected over 3 months – In HD patients, regular hemodialysis 4 h a session more than two times a week – In PD patients, over 2 exchange with more than 1.5 L solution Exclusion Criteria:

  • Poorly controlled hypertension, i.e. sitting blood pressure exceeding 180/110 despite medication requiring hospitalization or interruption of ESA treatment – Significant acute or chronic bleeding such as overt gastrointestinal bleeding within the previous 3 months – Active malignant disease (except non-melanoma skin cancer and patients with malignant disease who have been disease-free for at least the 5 previous years are eligible) – Acute infection – Hemolysis – Hemoglobinopathies (e.g. homozygous sickle-cell disease, thalassemia of all types) – Megaloblastic anemia – Platelet count >500 x 109/L or <100 x 109/L – Pure red call aplasia – Epileptic seizure during previous 3 months – Women of childbearing potential without effective contraception – Known hypersensitivity to recombinant human erythropoietin, polyethylene glycol – Planned elective surgery during the study period except for cataract surgery or laser photocoagulation – Life expectancy less than 12 month

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Kyungpook National University Hospital
  • Collaborator
    • Roche Pharma AG
  • Provider of Information About this Clinical Study
    • Principal Investigator: Yong-Lim Kim, MD, PhD – Kyungpook National University Hospital
  • Overall Official(s)
    • Yong-Lim Kim, Principal Investigator, Division of Nephrology, Department of Internal Medicine, Kyungpook National University School of Medicine

References

Malyszko J, Malyszko JS, Kozminski P, Mysliwiec M. Type of renal replacement therapy and residual renal function may affect prohepcidin and hepcidin. Ren Fail. 2009;31(10):876-83. doi: 10.3109/08860220903216071.

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