MedPath

Impact of Dialysis Modality on Hepcidin and Iron Metabolism

Completed
Conditions
End-stage Renal Disease
Registration Number
NCT01723111
Lead Sponsor
Kyungpook National University Hospital
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
120
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
ESA (Erythrocyte stimulating agents) dosesix months

We will compare ESA dose between PD patients and HD patients

Secondary Outcome Measures
NameTimeMethod
Hepcidin levelsix months

We will compare hepcidin level between PD patients and HD patients

hs-CRPsix months

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

IL-6six months

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

Total antioxidant capacitysix months

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

IV iron treatment (% of patients)six months

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

Transfusion ratesix months

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

Myeloperoxidasesix months

We will compare myeloperoxidase between PD patients and HD patients

TNF-asix months

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

Trial Locations

Locations (4)

Yeungnam University College of Medicine

🇰🇷

Daegu, Korea, Republic of

Daegu Fatima Hospital

🇰🇷

Daegu, Korea, Republic of

Dongsan Medical Center

🇰🇷

Daegu, Korea, Republic of

Kyungpook National University Hospital

🇰🇷

Daegu, Korea, Republic of

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