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Completed

NCT Number: NCT01723111

Impact of Dialysis Modality on Hepcidin and Iron Metabolism

* 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Daegu Fatima Hospital, Daegu, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. ESA (Erythrocyte stimulating agents) dose

    Time frame: six months

    We will compare ESA dose between PD patients and HD patients

Secondary outcomes

  1. IV iron treatment (% of patients)

    Time frame: six months

    We will compare IV iron treatment (% of patients) between PD patients and HD patients

  2. Hepcidin level

    Time frame: six months

    We will compare hepcidin level between PD patients and HD patients

  3. hs-CRP

    Time frame: six months

    We will compare hs-CRP level between PD patients and HD patients

  4. Myeloperoxidase

    Time frame: six months

    We will compare myeloperoxidase between PD patients and HD patients

  5. Transfusion rate

    Time frame: six months

    We will compare transfusion rate ( % of patients) between PD patients and HD patients

  6. TNF-a

    Time frame: six months

    We will compare TNF-a between PD patients and HD patients

  7. IL-6

    Time frame: six months

    We will compare IL-6 between PD patients and HD patients

  8. Total antioxidant capacity

    Time frame: six months

    We will compare total antioxidant capacity between PD patients and HD patients

Sponsors and collaborators

Lead sponsor

Kyungpook National University Hospital

Other

Collaborators

  • Fresenius Medical Care North America
  • Roche Pharma AG

Registry information

Official study title

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

Acronym: HERMES

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Nov 7, 2012
Registry last updated
Aug 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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