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Impact of Dialysis Modality on Hepcidin and Iron Metabolism (HERMES)

K

Kyungpook National University

Status

Completed

Conditions

End-stage Renal Disease

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT01723111
knuhhermes

Details and patient eligibility

About

  • 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 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.

Enrollment

120 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

120 participants in 2 patient groups

Peritoneal dialysis
Description:
start PD
Hemodialysis
Description:
start HD

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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