Clinical trial NCT01723111: Impact of Dialysis Modality on Hepcidin and Iron Metabolism
Official title: A Prospective, Multicenter, Observational Study to Evaluate the Impact of Peritoneal Dialysis Compared With Hemodialysis on Iron Metabolism and Hepcidin
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: End-stage Renal Disease
Keywords: hepcidin
ESA
hemodialysis
peritoneal dialysis
iron metabolism
dialysis modality
Lead sponsor: Kyungpook National University Hospital
Sponsor class: OTHER
Collaborators: name: Roche Pharma AG
name: Fresenius Medical Care North America
First posted: 2012-11-07
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: New ESRD patients whose dialysis treatment is expected over 3 months

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.

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
* 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

Primary outcomes:
measure: ESA (Erythrocyte stimulating agents) dose
timeFrame: six months
Secondary outcomes:
measure: IV iron treatment (% of patients)
timeFrame: six months
measure: Hepcidin level
timeFrame: six months
measure: hs-CRP
timeFrame: six months
measure: Myeloperoxidase
timeFrame: six months
measure: Transfusion rate
timeFrame: six months
measure: TNF-a
timeFrame: six months
measure: IL-6
timeFrame: six months
measure: Total antioxidant capacity
timeFrame: six months
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Daegu Fatima Hospital
city: Daegu
country: Korea, Republic of
facility: Dongsan Medical Center
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University College of Medicine
Study officials:
affiliation: Division of Nephrology, Department of Internal Medicine, Kyungpook National University School of Medicine
name: Yong-Lim Kim
role: PRINCIPAL_INVESTIGATOR
References:
citation: Malyszko J, Malyszko JS, Kozminski P, Mysliwiec M. Type of renal replacement therapy and residual renal function may affect prohepcidin and hepcidin. Ren Fail. 2009;31(10):876-83. doi: 10.3109/08860220903216071.