End-stage Renal Disease
Conditions
Keywords
hepcidin, ESA, hemodialysis, peritoneal dialysis, iron metabolism, dialysis modality
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.
Interventions
None listed
Sponsors
Roche Pharma AG
Fresenius Medical Care North America
Kyungpook National University Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ESA (Erythrocyte stimulating agents) dose | six months | We will compare ESA dose between PD patients and HD patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hepcidin level | six months | We will compare hepcidin level between PD patients and HD patients |
| hs-CRP | six months | We will compare hs-CRP level between PD patients and HD patients |
| Myeloperoxidase | six months | We will compare myeloperoxidase 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 |
| TNF-a | six months | We will compare TNF-a between PD patients and HD patients |
| IL-6 | six months | We will compare IL-6 between PD patients and HD patients |
| Total antioxidant capacity | six months | We will compare total antioxidant capacity between PD patients and HD patients |
| Transfusion rate | six months | We will compare transfusion rate ( % of patients) between PD patients and HD patients |
Countries
South Korea
Outcome results
None listed