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Clinical Trials/NCT01723111
NCT01723111
Completed
Not Applicable

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

Kyungpook National University Hospital4 sites in 1 country120 target enrollmentNovember 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
End-stage Renal Disease
Sponsor
Kyungpook National University Hospital
Enrollment
120
Locations
4
Primary Endpoint
ESA (Erythrocyte stimulating agents) dose
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

  • 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.

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.

Registry
clinicaltrials.gov
Start Date
November 2012
End Date
August 2016
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yong-Lim Kim

MD, PhD

Kyungpook National University Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

ESA (Erythrocyte stimulating agents) dose

Time Frame: six months

We will compare ESA dose between PD patients and HD patients

Secondary Outcomes

  • Hepcidin level(six months)
  • hs-CRP(six months)
  • IL-6(six months)
  • Total antioxidant capacity(six months)
  • IV iron treatment (% of patients)(six months)
  • Transfusion rate(six months)
  • Myeloperoxidase(six months)
  • TNF-a(six months)

Study Sites (4)

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