Impact of Dialysis Modality on Hepcidin and Iron Metabolism

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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End-stage Renal Disease

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Peritoneal dialysis<br>start PD | |
| Hemodialysis<br>start HD | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ESA (Erythrocyte stimulating agents) dose | We will compare ESA dose between PD patients and HD patients | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IV iron treatment (% of patients) | We will compare IV iron treatment (% of patients) between PD patients and HD patients | six months | 
| Hepcidin level | We will compare hepcidin level between PD patients and HD patients | six months | 
| hs-CRP | We will compare hs-CRP level between PD patients and HD patients | six months | 
| Myeloperoxidase | We will compare myeloperoxidase between PD patients and HD patients | six months | 
| Transfusion rate | We will compare transfusion rate ( % of patients) between PD patients and HD patients | six months | 
| TNF-a | We will compare TNF-a between PD patients and HD patients | six months | 
| IL-6 | We will compare IL-6 between PD patients and HD patients | six months | 
| Total antioxidant capacity | We will compare total antioxidant capacity between PD patients and HD patients | six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hepcidin, ESA, hemodialysis, peritoneal dialysis, iron metabolism, dialysis modality